Sophic Logo gordian knotOvarian and Endometrial Cancer Clinical Trials Intelligence

Monthly Update Report for Trials Started in December 2025


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1: Summary data from new trials identified for Ovarian and Endometrial Cancer.


Overview

Number of Trials: 14

These 14 trials span a diverse range of gynecologic and other solid tumor cancers, with a strong focus on ovarian, endometrial, and breast cancers. Several trials test novel targeted therapies, including RBM39 degraders, fascin inhibitors, WRN inhibitors, and antibody-drug conjugates targeting folate receptor alpha. Others evaluate repurposed drugs (nelfinavir, hydroxychloroquine), combination strategies with PARP inhibitors or checkpoint inhibitors, and innovative delivery models such as at-home cancer care and nanotechnology-based hyperthermia. Behavioral and imaging studies complement the therapeutic trials, addressing fear of progression, endometrial inflammation, and advanced ultrasound diagnostics. Many trials focus on platinum-resistant or recurrent disease, BRCA/HRD-positive populations, and biomarker-driven patient selection.

Common Criteria Across Trials

Common Inclusion

  • Age ≥18 years
  • Histologically or cytologically confirmed malignancy
  • Measurable disease per RECIST 1.1
  • ECOG performance status 0-2
  • Adequate organ function (hematologic, hepatic, renal)
  • Absolute neutrophil count ≥1,000-1,500/μL
  • Platelet count ≥75,000-100,000/μL
  • Hemoglobin ≥9-10 g/dL
  • Serum creatinine ≤1.5× ULN or creatinine clearance ≥35-51 mL/min
  • AST/ALT ≤2.5-5× ULN
  • Total bilirubin ≤1.5× ULN
  • Negative pregnancy test for women of childbearing potential
  • Willingness to use contraception
  • Ability to provide informed consent

Common Exclusion

  • Active or untreated CNS metastases
  • Uncontrolled intercurrent illness or active infection
  • Major surgery within 2-4 weeks
  • Prior radiotherapy within 2-4 weeks
  • Chemotherapy or investigational therapy within 14-21 days
  • Unresolved toxicities >Grade 1 from prior therapy (except alopecia)
  • Pregnant or breastfeeding
  • History of myocardial infarction or unstable cardiac disease within 6 months
  • Known HIV, HBV, or HCV infection
  • History of interstitial lung disease or pneumonitis
  • Concurrent malignancy requiring active treatment
  • Psychiatric or neurological disorder impairing compliance

2: Extracted Trials with New Information


Trials with Special Criteria

Genomic / Biomarker Trials

Unique or Unusual Criteria

Trials with Emerging Treatments


3: Individual Trial Overviews


NCT06971744

Autophagy Maintenance (AUTOMAIN) Therapy in High-Grade Serous Ovarian Cancer: A Phase II Trial Genomic-based

Organization/Sponsor: Medical University of South Carolina


Example patient: A 58-year-old woman with platinum-sensitive first recurrent high-grade serous ovarian cancer, BRCA1 mutation positive, who completed 6 cycles of carboplatin/paclitaxel with bevacizumab achieving complete response, ECOG 1, with controlled hypertension and no cardiac disease.

Phase II

Interventions

  • Biological: Bevacizumab
    Summary: Recombinant humanized monoclonal antibody that inhibits VEGF, blocking tumor angiogenesis by preventing new blood vessel formation required for tumor growth and metastasis; indicated for ovarian cancer maintenance therapy (FDA label, NCI Thesaurus).
  • Drug: Nelfinavir
    Summary: HIV-1 protease inhibitor that selectively binds and inhibits HIV protease and cytochrome P450 3A; being repurposed for potential anticancer effects in this trial (FDA label, NCI Thesaurus).
  • Drug: Hydroxychloroquine
    Summary: Antimalarial and antirheumatic 4-aminoquinoline that raises intralysosomal pH, impairing autophagic protein degradation; may cause cell death in tumor cells reliant on autophagy for survival (FDA label, NCI Thesaurus).

Key Inclusion

  • Platinum-sensitive first recurrent high-grade serous or predominantly serous ovarian, fallopian tube, or primary peritoneal cancer
  • Disease-free progression of at least 6 months since last platinum chemotherapy
  • Known BRCA 1/2 mutation status and/or HRD/LOH testing completed
  • Enrolled within 3-8 weeks of first day of last cycle of platinum-based chemotherapy for first recurrence
  • Received at least 3 courses of bevacizumab during chemotherapy with plan to continue maintenance
  • Partial or complete response to current platinum-based chemotherapy
  • ECOG performance status 0-2
  • Adequate organ function and controlled blood pressure

Key Exclusion

  • Platinum resistant or refractory disease
  • NYHA Class III or IV cardiac disease or myocardial infarction within 6 months
  • Candidates for PARP inhibitor maintenance unless previously intolerant
  • Receiving coumadin or unable to stop strong CYP inhibitors/inducers
  • Unable to discontinue statin use within 48 hours of study treatment
  • G6PD deficiency, myasthenia gravis, or porphyria
  • High ASCVD score requiring continued statin therapy
  • Contraindications to bevacizumab per approved labeling

NCT07197554

A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies

Organization/Sponsor: SEED Therapeutics, Inc.


Example patient: A 52-year-old woman with metastatic ovarian cancer refractory to standard chemotherapy, ECOG status 1, with measurable peritoneal disease, adequate organ function, and no prior RBM39-targeted therapy.

Phase 1

Interventions

  • Drug: ST-01156
    Summary: ST-01156 is an oral small molecule RBM39 degrader that targets and degrades the RBM39 protein to inhibit cancer growth in advanced solid tumors including ovarian and endometrial cancers (Source: Web Search).

Key Inclusion

  • Age ≥18 years, or ≥16 years for Ewing Sarcoma or malignancies with biological rationale
  • Metastatic or locally advanced and unresectable solid tumor
  • At least 1 measurable lesion or evaluable disease per RECIST v1.1
  • ECOG performance status ≤2 at screening
  • Adequate organ function as defined in protocol

Key Exclusion

  • Received prior radiotherapy within 2 weeks of treatment
  • Known active CNS metastases or carcinomatous meningitis
  • Received anticancer therapy or investigational agent within 14 days or 5 half-lives
  • Major surgery within 28 days before study therapy
  • Unresolved toxicities from previous anticancer therapies except alopecia and peripheral neuropathy
  • Previously received a RBM39 inhibitor or degrader

NCT07285044

Cancer CARE (Connected Access and Remote Expertise) Beyond Walls - Pilot, Phase 2 Clinical Trial to Evaluate Administration of Cancer-Directed Therapy in the Patient's Homes Versus in Clinic in the Florida Panhandle and Surrounding Areas

Organization/Sponsor: Mayo Clinic


Example patient: A 62-year-old woman with stage III ovarian cancer receiving pembrolizumab and bevacizumab with ECOG PS 1, living independently in the Florida Panhandle with Wi-Fi access, tolerating treatment well and planning to continue therapy for at least 12 weeks.

Phase 2

Interventions

  • Procedure: Questionnaire Administration
    Summary: Administration of questionnaires to assess patient-reported outcomes and experiences during at-home cancer therapy delivery (NCI Thesaurus).
  • Procedure: Cancer Therapeutic Procedure
    Summary: Standard-of-care cancer treatment interventions including immunotherapy, targeted therapy, chemotherapy, and hormonal agents administered in the patient's home setting (NCI Thesaurus).

Key Inclusion

  • Histologically confirmed malignancy including ovarian, endometrial, fallopian tube, peritoneal, breast, colorectal, lung, or other eligible cancer types
  • Currently receiving standard-of-care treatment with eligible regimens such as pembrolizumab, nivolumab, bevacizumab, trastuzumab, or other listed agents
  • Age 18 years or older
  • ECOG performance status 0-3
  • Adequate tolerability of standard-of-care treatment without clinically significant drug-related reactions
  • Resides within Florida Panhandle and surrounding area with Wi-Fi connection capability
  • Plans to continue eligible treatment regimen for at least 12 weeks from registration
  • Social stability appropriate for at-home care program participation

Key Exclusion

  • Co-morbid systemic illnesses or severe concurrent disease that would interfere with safety assessment
  • Receiving investigational agents for primary neoplasm treatment
  • Requires continuous 24/7 assistance with daily living without available caregiver support
  • Current inpatient hospitalization excluding Advanced Care at Home program admission

NCT07224464

Open Label Feasibility Dose Escalation Study to Evaluate the Safety of Sarah Nanotechnology System, With Alternating Magnetic Field (AMF) Application in Patients With Advanced Metastatic Solid Tumors.

Organization/Sponsor: New Phase Ltd.


Example patient: A 62-year-old woman with metastatic ovarian cancer refractory to platinum-based chemotherapy and PARP inhibitors, ECOG 1, with thoracic and abdominal disease, no brain metastases, and rib cage circumference 85 cm.

Phase N/A

Interventions

  • Device: The Sarah Nanotechnology System
    Summary: A nanotechnology-based system that delivers thermal energy via alternating magnetic field to induce hyperthermia for thermal destruction of malignant cells in advanced metastatic solid tumors (NCI Thesaurus).

Key Inclusion

  • Histologically confirmed advanced metastatic solid tumors between thoracic inlet and pelvic floor
  • Progressed on or after standard therapy and ineligible for surgical resection
  • Measurable disease according to RECIST 1.1
  • Exhausted all standard treatment options
  • No prior history of brain metastasis
  • Age ≥18 years
  • Rib cage circumference ≤90 cm
  • ECOG performance status ≤2

Key Exclusion

  • Chemotherapy, radiotherapy or hormonal therapy within 14 days before screening
  • Immunotherapy or investigational agent within 21 days before screening
  • Residual toxicities >Grade 1 from prior anti-cancer therapy
  • Presence or prior history of brain metastases
  • Uncontrolled intercurrent illness including active infection or cardiac conditions
  • Pregnant or breastfeeding
  • Electronic or electronically conductive implants or metals in body
  • Unable to lay down with hands extended over head

NCT07318415

Quantitative Assessment of Vaginal Tissue Response to Intravaginal Brachytherapy With Multiparametric Ultrasound Imaging (mpUS)

Organization/Sponsor: Memorial Sloan Kettering Cancer Center


Example patient: A 52-year-old woman with FIGO stage IB endometrioid endometrial carcinoma who underwent hysterectomy, bilateral salpingo-oophorectomy, and sentinel lymph node mapping with negative margins, scheduled to begin intravaginal brachytherapy 8 weeks post-surgery.

Phase N/A

Interventions

  • Assessment Tool: The vaginal assessment score (VAS)
    Summary: A four-item clinician-administered measure using a four-point rating scale to assess patient perception of vaginal dryness, soreness, irritation, and pain (NCI Thesaurus).
  • Imaging: Multiparametric Ultrasound Imaging
    Summary: Uses multiple ultrasound imaging techniques targeting tissue characteristics to enhance detection and diagnosis accuracy in endometrial and ovarian cancer (Web Search Summary).

Key Inclusion

  • Primary endometrial carcinoma with eligible histologic subtypes including endometrioid, serous, clear cell, carcinosarcoma
  • Hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymph node assessment completed
  • Complete surgical resection with negative margins and no residual gross disease
  • FIGO 2009 stage I-II disease per surgical staging
  • Age 18 years or older
  • Able to start radiotherapy within 12 weeks from surgery

Key Exclusion

  • Receiving chemotherapy or hormonal therapy
  • Prior or concurrent malignancy interfering with toxicity or efficacy assessment
  • Prior pelvic radiotherapy
  • Active genitourinary infection requiring antibiotics except uncomplicated UTI
  • History of active inflammatory bowel disease including Crohn's or ulcerative colitis
  • Concurrent psychiatric or medical condition making patient unsuitable per investigator

NCT07322094

CATALINA-4: Phase 1B/2 Study of TORL-1-23 With Neoadjuvant Chemotherapy and Interval Cytoreductive Surgery in Newly Diagnosed Patients With Advanced Stage Ovarian Cancer Genomic-based

Organization/Sponsor: TORL Biotherapeutics, LLC


Example patient: A 58-year-old woman with newly diagnosed FIGO Stage III epithelial ovarian cancer positive for CLDN6 expression, ECOG performance status 1, with adequate organ function and no prior treatment or surgery.

Phase 1B, Phase 2

Interventions

  • Combination: TORL-1-23, paclitaxel, and carboplatin
    Summary: TORL-1-23 is a novel therapeutic targeting CLDN6 in ovarian cancer. Carboplatin is a platinum-based chemotherapy that disrupts cancer cell DNA. Paclitaxel disrupts microtubules. Source: FDA label and Web Search.
  • Combination: TORL-1-23 and carboplatin
    Summary: TORL-1-23 targets CLDN6 in ovarian cancer; carboplatin is a platinum agent disrupting DNA. Source: Web Search.
  • Combination: TORL-1-23 and paclitaxel
    Summary: TORL-1-23 targets CLDN6 in ovarian cancer with efficacy in platinum-resistant cases; paclitaxel disrupts microtubules. Source: Web Search.

Key Inclusion

  • ECOG performance status ≤2
  • Histologically or cytologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube cancer
  • FIGO Stage III or IV
  • Positive for CLDN6 expression
  • Adequate organ function

Key Exclusion

  • Clear cell, mucinous, sarcomatous, mixed histology, low-grade/borderline, or non-epithelial ovarian cancers
  • Prior systemic treatment for the disease under study
  • Prior surgery
  • Prior radiation therapy to abdomen or pelvis
  • Active, progressive, or symptomatic brain metastases
  • Pregnant or breastfeeding women

NCT07109414

Randomized Phase 2/3 Trial of NP-G2-044 (Prilukae) Combined With PLD for Treatment of Platinum-Resistant Ovarian Cancer (ULTIMUS-1)

Organization/Sponsor: Novita Pharmaceuticals, Inc.


Example patient: A 62-year-old woman with platinum-resistant high-grade serous ovarian cancer who progressed 150 days after her last platinum therapy, previously treated with bevacizumab, ECOG 1, with measurable peritoneal disease and adequate organ function.

Phase 2, Phase 3

Interventions

  • Drug: NP-G2-044
    Summary: An orally available fascin inhibitor that prevents actin bundling and filopodia formation, thereby impairing tumor cell migration and metastasis in ovarian cancer (NCI Thesaurus).
  • Drug: PLD
    Summary: Poly(lactic-co-glycolic acid) nanoparticles delivering chemotherapy directly to tumors in ovarian cancer, minimizing systemic side effects through targeted delivery (Web Search).

Key Inclusion

  • Confirmed ovarian high-grade serous carcinoma
  • Platinum resistance
  • No PLD use after developing platinum resistance
  • Prior bevacizumab or ineligible for bevacizumab
  • ECOG status 0-1
  • Measurable disease per RECIST v1.1
  • Left ventricular ejection fraction > 50%
  • Adequate hematologic, hepatic, and renal function

Key Exclusion

  • Primary platinum-refractory disease (recurrence within 120 days of first-line platinum)
  • Platinum-sensitive recurrence (>183 days from penultimate platinum)
  • Uncontrolled pleural effusions or ascites requiring drainage within 60 days
  • Active CNS metastases or leptomeningeal disease
  • Severe gastrointestinal conditions or bowel obstruction
  • Liver metastases involving >60% of parenchyma
  • QTcF >470 ms
  • Grade 2 or greater neuropathy

NCT07281547

Mechanistic Randomized Controlled Feasibility Trial of Aspirin on Endometrium and Inflammatory Metabolites in Postmenopausal Women With Non-Atrophic Endometrial Changes

Organization/Sponsor: Mayo Clinic


Example patient: A 58-year-old postmenopausal woman with obesity and postmenopausal bleeding, found to have 6mm thickened endometrium on ultrasound, scheduled for endometrial biopsy, with no history of gynecologic malignancy and able to tolerate NSAIDs.

Phase N/A

Interventions

  • Procedure: Ultrasound Imaging
    Summary: High-frequency sound waves generate body images for diagnostic purposes (NCI Thesaurus).
  • Other: Questionnaire Administration
    Summary: Participants complete questionnaires to collect clinical and risk factor data (NCI Thesaurus).
  • Other: Patient Observation
    Summary: Closely monitoring patient condition with regular exams without immediate treatment unless changes occur (NCI Thesaurus).
  • Drug: Low-Dose Aspirin
    Summary: NSAID inhibiting cyclooxygenase enzymes to reduce prostaglandin production and platelet aggregation, providing anti-inflammatory and analgesic effects at 81-100mg doses (FDA label, NCI Thesaurus).
  • Procedure: Biospecimen Collection
    Summary: Collection of blood, tissue, and urine samples for correlative research and testing purposes (NCI Thesaurus).

Key Inclusion

  • Postmenopausal women (no period for over 1 year or postmenopausal hormone levels)
  • Pain and findings warranting endometrial sampling (postmenopausal bleeding, thickened endometrium >4mm, obesity, fibroids)
  • Scheduled endometrial biopsy
  • Willingness to provide blood, tissue, and urine specimens for research
  • Understands English or Spanish language
  • Within Mayo Clinic Comprehensive Cancer Center area

Key Exclusion

  • Previous hysterectomy (removal of uterus)
  • Atrophic endometrium on endometrial sampling
  • History of uterine, cervical, or ovarian cancers or precancers
  • Contraindication to NSAIDs or previous adverse reaction to NSAIDs
  • Clinically contraindicated to discontinue anticoagulation other than aspirin
  • Patients from outside Mayo Clinic Comprehensive Cancer Center area

NCT06856499

Phase I Evaluation of Combination CLK/DYRK (Cirtuvivint) Inhibition With PARP Inhibition (Olaparib) in BRCA/HRD Platinum Resistant Ovarian Cancer Genomic-based

Organization/Sponsor: University of Colorado, Denver


Example patient: A 52-year-old woman with BRCA1-mutated high-grade serous ovarian cancer who progressed 4 months after completing carboplatin/paclitaxel and olaparib maintenance, with measurable peritoneal disease, ECOG PS 1, and adequate organ function.

Phase 1

Interventions

  • Drug: Olaparib
    Summary: Olaparib is a PARP inhibitor that blocks DNA repair enzymes, causing synthetic lethality in BRCA-mutated or HRD tumors by preventing single-strand DNA break repair, leading to cancer cell death; FDA-approved for ovarian, breast, pancreatic, and prostate cancers with BRCA mutations or homologous recombination deficiency (FDA label, NCI Thesaurus).
  • Drug: Cirtuvivint
    Summary: Cirtuvivint is a small-molecule inhibitor targeting CDC-like kinases (CLK) and DYRK kinases, disrupting cancer cell growth pathways; being tested in combination with olaparib for ovarian cancer treatment (Web Search Summary).

Key Inclusion

  • High-grade serous or endometrioid epithelial ovarian, primary peritoneal, or fallopian tube cancer
  • Platinum-resistant disease (progression <6 months from last platinum dose)
  • Measurable disease by RECIST 1.1 criteria
  • BRCA mutation (tumor or germline) and/or tumor HRD positive
  • Prior PARP inhibitor as treatment or maintenance therapy
  • 1-3 prior lines of systemic therapy including at least one platinum-based regimen
  • ECOG performance status 0-2
  • Adequate hematologic, liver, and kidney function

Key Exclusion

  • Clear cell, mucinous, sarcomatous, low grade/borderline, germ cell, or sex-cord stromal ovarian tumors
  • Platinum refractory disease (progression during or within 4 weeks of platinum therapy)
  • Myelodysplastic syndrome/acute myeloid leukemia or suggestive features
  • Systemic chemotherapy or radiotherapy within 3 weeks prior to study treatment
  • Clinically significant cardiac disease including recent myocardial infarction or uncontrolled arrhythmias
  • Untreated or symptomatic CNS metastases
  • GI disorder interfering with oral medication absorption
  • Persistent grade ≥2 toxicities from prior cancer therapy (excluding alopecia or neuropathy)

NCT07226102

An E-Health Intervention for Fear of Progression in Women With Gynecologic or Breast Cancer

Organization/Sponsor: City of Hope Medical Center


Example patient: A 52-year-old English-speaking woman with stage III high-grade serous ovarian cancer, 4 months post-diagnosis, currently in remission but experiencing severe fear of recurrence with a Fear of Progression score of 38, without major depression or hospice enrollment.

Phase N/A

Interventions

  • Behavioral: Virtual Technology Intervention
    Summary: An immersive, computer-generated environment for interaction and navigation, used to address fear of cancer progression through behavioral modification (NCI Thesaurus).
  • Procedure: Survey Administration
    Summary: Presentation of surveys or questionnaires to obtain patient responses for assessment of fear of progression and related outcomes (NCI Thesaurus).
  • Procedure: Interview
    Summary: Structured conversation to gather patient background, personal details, and opinions on intervention experiences and psychological outcomes (NCI Thesaurus).
  • Behavioral: Internet-Based Intervention
    Summary: Web-based program designed to alter or eliminate dysfunctional fear behaviors related to cancer progression (NCI Thesaurus).
  • Behavioral: Educational Intervention
    Summary: Educational activities intended to prevent or alter disease course by addressing psychological distress and fear in cancer patients (NCI Thesaurus).
  • Behavioral: Behavioral Intervention
    Summary: Operant conditioning using rewards and punishments to help patients reduce contribution to painful psychological stimuli and manage fear (NCI Thesaurus).

Key Inclusion

  • Women with stage III or IV gynecologic (ovarian, endometrial, cervical, vulvar/vaginal) or breast cancer
  • At least 2 months from initial diagnosis
  • High-risk disease including carcinosarcoma, ovarian cancer stage II or grade III, endometrioid endometrial cancer stage II or III with grade III LVI or deep invasion, serous, clear cell or undifferentiated histologies, triple negative breast cancer
  • Score ≥34 on Fear of Progression Short-Form indicating dysfunctional levels
  • Age 18 or older
  • Able to read and understand English
  • Patients in remission or with progressive disease

Key Exclusion

  • Enrolled in hospice
  • Major depression as assessed by PHQ-9
  • Non-English speaking
  • Unable to comply with study procedures in investigator opinion

NCT07218809

A Randomised, Open-label, Phase III Study of AZD5335 Versus Mirvetuximab Soravtansine in FRα-high and AZD5335 Versus Investigator's Choice Chemotherapy in FRα-low Expressing High-grade Platinum-resistant Epithelial Ovarian Cancer Patients (TREVI-OC-01) Genomic-based

Organization/Sponsor: AstraZeneca


Example patient: A 62-year-old woman with high-grade serous ovarian cancer and germline BRCA1 mutation who progressed 5 months after completing second-line platinum-based chemotherapy and prior PARPi treatment, now requiring single-agent therapy.

Phase III

Interventions

  • Drug: Topotecan
    Summary: Topotecan is a topoisomerase I inhibitor that stabilizes topoisomerase I-DNA complexes during S phase, preventing DNA religation and producing lethal double-strand breaks to inhibit tumor cell replication (FDA label, NCI Thesaurus).
  • Drug: Pegylated liposomal Doxorubicin (PLD)
    Summary: Liposomal-encapsulated doxorubicin is an anthracycline topoisomerase inhibitor indicated for platinum-resistant ovarian cancer that prevents DNA replication in cancer cells, with cardiotoxicity as a key safety concern (FDA label, NCI Thesaurus).
  • Drug: Paclitaxel
    Summary: Paclitaxel is a microtubule inhibitor extracted from Pacific yew that binds tubulin, inhibits microtubule disassembly, disrupts cell division, and induces apoptosis by blocking Bcl-2 function (FDA label, NCI Thesaurus).
  • Biological: Mirvetuximab Soravtansine (MIRV)
    Summary: An antibody-drug conjugate combining anti-FRα monoclonal antibody with DM4 maytansinoid via cleavable linker, delivering targeted microtubule inhibition to FRα-positive cancer cells in platinum-resistant ovarian cancer (FDA label, NCI Thesaurus).
  • Biological: AZD5335
    Summary: An antibody-drug conjugate composed of torvutatug (anti-FRα antibody) conjugated to exatecan via samrotecan linker, targeting FRα-expressing tumor cells and inhibiting topoisomerase I to induce DNA breaks and apoptosis (NCI Thesaurus).

Key Inclusion

  • High-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer
  • Platinum-resistant disease (progression ≤6 months after last platinum dose)
  • 1-3 prior systemic anti-cancer therapy lines
  • Radiologically progressed on or after most recent therapy
  • Single-agent therapy appropriate as next treatment
  • Prior PARPi required if BRCA mutated (unless contraindicated)
  • FFPE tumor tissue sample provided
  • At least 4 cycles of platinum with response (CR/PR) for single prior line patients

Key Exclusion

  • Endometrioid, clear cell, mucinous, sarcomatous, low-grade, or borderline histology
  • Primary platinum-refractory disease (progression ≤3 months after first-line platinum)
  • Active/chronic corneal disorders or history of corneal transplantation
  • Current signs of bowel obstruction including sub-occlusive disease
  • Non-infectious ILD/pneumonitis or history requiring steroids/oxygen
  • Prior FRα-targeted therapy including MIRV or TOP1i ADC
  • Major surgical procedure within 4 weeks of first dose

NCT07280312

Ultrasound Imaging of Ovarian and Adnexal Lesions

Organization/Sponsor: Mayo Clinic


Example patient: A 52-year-old woman with a newly identified ovarian mass on imaging scheduled for surgical resection without prior ovarian surgery or chemotherapy.

Phase N/A

Interventions

  • Procedure: Ultrasound Microvessel Imaging
    Summary: An ultrasound imaging technique using enhanced vessel detection sensitivity to evaluate microvasculature structure and function (NCI Thesaurus).
  • Procedure: Transvaginal Ultrasound
    Summary: Ultrasound probe inserted vaginally creates images of female genital tract to evaluate infertility, bleeding, pain, malformations, tumors, and infection (NCI Thesaurus).

Key Inclusion

  • Female patients aged ≥ 18 years
  • Scheduled for surgery for ovarian or adnexal lesions

Key Exclusion

  • Prior surgical removal of ovarian or adnexal lesions
  • Undergoing neoadjuvant chemotherapy
  • Undergoing targeted systemic therapy
  • Prisoners
  • Adults lacking capacity to consent
  • Pregnant women

NCT07102797

ActiveGirls: Physical Activity, Hormone Health, and Diabetes Risk in Early Adolescence

Organization/Sponsor: Massachusetts General Hospital


Example patient: An 11-year-old pre-menarchal English-speaking girl with BMI at 90th percentile and maternal history of PCOS, without diabetes or conditions limiting physical activity participation.

Phase N/A

Interventions

  • Behavioral: ActiveGirls Physical Activity Program (Delayed Lower Intensity)
    Summary: Physical activity program using wearable technology and personalized exercise with counseling to improve activity levels and quality of life in at-risk girls (Web Search).
  • Behavioral: ActiveGirls Physical Activity Program (Full)
    Summary: Physical activity intervention targeting hormone health and diabetes risk in pre-menarchal girls aged 8-12 at risk for PCOS and insulin resistance (Web Search).

Key Inclusion

  • Female ages 8-12 years old
  • Pre-menarchal at baseline
  • At risk for PCOS/insulin resistance
  • History of maternal PCOS or gestational diabetes
  • BMI ≥85th percentile
  • History of premature adrenarche or small for gestational age
  • English-speaking child and caregiver
  • Caregiver access to device for study communications

Key Exclusion

  • Current use of metformin, GLP-1R agonist, insulin, or GnRH agonist
  • Type 1 or Type 2 diabetes
  • Congenital adrenal hyperplasia or adrenal tumor
  • Uncontrolled hypothyroidism (TSH >7.0 mIU/mL)
  • Growth hormone deficiency
  • Cardiovascular, neurologic, or musculoskeletal conditions limiting physical activity
  • Severe congenital heart disease, cystic fibrosis, or cerebral palsy
  • Significant cardiac, hepatic, oncologic, inflammatory, or psychiatric disease

NCT07262619

A Multicenter, Multi-Part, Phase 1/2 Study of EIK1005 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors, Including Checkpoint Inhibitor Naïve Participants With Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Tumors Genomic-based

Organization/Sponsor: Eikon Therapeutics


Example patient: A 62-year-old woman with metastatic MSI-H endometrial cancer, ECOG 1, who progressed after pembrolizumab and platinum-based chemotherapy, with adequate organ function and no active autoimmune disease.

Phase 1, Phase 2

Interventions

  • Biological: Pembrolizumab (KEYTRUDA®)
    Summary: Humanized monoclonal antibody blocking PD-1 to enhance immune-mediated tumor destruction, FDA-approved for numerous solid and hematologic malignancies including melanoma, NSCLC, head and neck cancers, lymphomas, and various advanced cancers. Requires monitoring for immune-related adverse events affecting multiple organ systems (FDA label, NCI Thesaurus).
  • Drug: EIK1005
    Summary: Experimental WRN inhibitor being studied for advanced solid tumors with MSI-H or dMMR status; exact mechanism not publicly disclosed, aims to determine safe effective dose (Web Search).

Key Inclusion

  • Age ≥18 years
  • Advanced (unresectable/metastatic) solid tumor histologically or cytologically confirmed
  • Part 1B/2: MSI-H or dMMR tumor locally confirmed with archival tissue ≤3 years old
  • Progressed after or intolerant to ≥1 standard treatment regimen
  • Measurable disease per RECIST 1.1
  • ECOG performance status 0-1
  • Adequate organ and marrow function
  • Life expectancy ≥3 months

Key Exclusion

  • Prior treatment with WRN inhibitor
  • Active CNS metastases or carcinomatous meningitis unless stable ≥4 weeks
  • Mean resting QTcF >470 ms
  • Active autoimmune disease requiring systemic treatment in past 2 years
  • History of pneumonitis/interstitial lung disease requiring steroids
  • Chronic systemic steroid therapy >10 mg prednisone equivalent (Parts 1B/2)
  • Active infections requiring systemic therapy
  • Additional progressing malignancy requiring active treatment within 3 years