Bladder Cancer Clinical Trials Intelligence
Monthly Update Report - October 2025
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Important Notice:
Sophic does not practice medicine nor provide medical advice. The Sophic Starlight Cancer Clinical Trials Intelligence Report is intended solely as an educational resource that provides access to publicly available clinical trial data integrated within Sophic’s proprietary knowledgebase and summarized with AI. This report is not a substitute for professional medical advice, diagnosis, or treatment.
Sophic does not practice medicine nor provide medical advice. The Sophic Starlight Cancer Clinical Trials Intelligence Report is intended solely as an educational resource that provides access to publicly available clinical trial data integrated within Sophic’s proprietary knowledgebase and summarized with AI. This report is not a substitute for professional medical advice, diagnosis, or treatment.
1: Summary data from new trials identified for Bladder Cancer.
Overview
Number of Trials: 2
Two Phase 1 trials are evaluating novel therapies for advanced bladder cancer and other solid tumors. NCT07206225 tests PF-08052667, an antibody-drug conjugate, as monotherapy and combined with sasanlimab (PD-1 inhibitor) in BCG-unresponsive non-muscle invasive bladder cancer. NCT07218003 evaluates RNDO-564, a bispecific antibody targeting Nectin-4, alone and with pembrolizumab in relapsed/refractory locally advanced or metastatic urothelial cancer and other Nectin-4-expressing solid tumors including NSCLC, HNSCC, TNBC, and gastric cancers.
Common Criteria Across Trials
Common Inclusion
- Adults 18 years or older
- Histologically confirmed advanced or metastatic solid tumors
- Measurable disease per RECIST v1.1
- Adequate organ function
- ECOG performance status 0-1
- Prior standard therapy failure, intolerance, or refusal
Common Exclusion
- Active uncontrolled infection
- Renal or hepatic impairment
- Hematologic abnormalities
- Peripheral neuropathy greater than Grade 2
- Concomitant anti-cancer therapy for bladder cancer
- Prior radiation therapy to bladder
2: Extracted Trials with New Information
Trials with Special Criteria
Genomic / Biomarker Trials
- NCT07218003 — Requires Nectin-4 expression in solid tumors
Unique or Unusual Criteria
- NCT07206225 — Requires BCG-unresponsive disease with at least 5 of 6 BCG induction doses; patients must have refused or be ineligible for radical cystectomy
- NCT07218003 — Allows up to 2 prior MMAE-containing therapies; excludes active inflammatory skin diseases requiring biologics or oral steroids; limits prior Nectin-4 targeted agents to one
Trials with Emerging Treatments
- NCT07206225 — A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTITUMOR ACTIVITY OF PF-08052667 AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 18 YEARS OF AGE AND OLDER WITH BLADDER CANCER
Items: PF-08052667 (SGN-B6N), PF-02921367 (DDM), Sasanlimab (PF-06801591)
Note: PF-08052667 is an investigational antibody-drug conjugate for intravesical delivery in bladder cancer; PF-02921367 is an investigational androgen receptor modulator; Sasanlimab is a PD-1 inhibitor under investigation - NCT07218003 — An Open-Label, Multicenter, Phase 1/1b Study of RNDO-564 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Relapsed/Refractory Locally Advanced or Metastatic Urothelial Cancer and Other Solid Tumors Associated With Nectin-4 Expression
Items: RNDO-564
Note: RNDO-564 is a novel bispecific antibody targeting both CD28 and Nectin-4 to induce tumor killing in Nectin-4-positive cancers
3: Individual Trial Overviews
NCT07206225
A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTITUMOR ACTIVITY OF PF-08052667 AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 18 YEARS OF AGE AND OLDER WITH BLADDER CANCER
Organization/Sponsor: Pfizer
Example patient: A 67-year-old patient with BCG-unresponsive carcinoma in situ of the bladder, ECOG status 0, who declined radical cystectomy and has adequate organ function without active infections.
Phase 1
NCT07206225
A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTITUMOR ACTIVITY OF PF-08052667 AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 18 YEARS OF AGE AND OLDER WITH BLADDER CANCER
Organization/Sponsor: Pfizer
Example patient: A 67-year-old patient with BCG-unresponsive carcinoma in situ of the bladder, ECOG status 0, who declined radical cystectomy and has adequate organ function without active infections.
Phase 1
Interventions
-
Drug: PF-08052667
Summary: An antibody-drug conjugate targeting non-muscle-invasive bladder cancer, designed for intravesical delivery and tested in combination with other treatments (Summary of Web Search). -
Drug: PF-02921367
Summary: An investigational drug targeting the androgen receptor via selective androgen receptor modulation, with limited data on efficacy and safety in bladder cancer (Summary of Web Search). -
Biological: BCG
Summary: Attenuated live Mycobacterium bovis vaccine administered intravesically to treat and prevent bladder carcinoma in situ and recurrent papillary tumors by stimulating local immune responses including macrophage proliferation (FDA label, NCI Thesaurus). -
Biological: Sasanlimab
Summary: A PD-1 inhibitor that blocks interaction with PD-L1 and PD-L2, restoring immune function by activating NK cells and cytotoxic T-lymphocytes against tumor cells (NCI Thesaurus).
Key Inclusion
- 18 years of age or older
- Histological diagnosis of high-risk non-muscle invasive urothelial carcinoma with carcinoma in situ (CIS)
- BCG unresponsive or BCG-exposed with persistent or recurrent disease after at least 5 out of 6 BCG induction doses
- Refused or ineligible for radical cystectomy
- Available tumor tissue within last 6 months
- ECOG performance status 0 or 1
Key Exclusion
- Concomitant anti-cancer therapy for NMIBC
- Prior radiation therapy to the bladder
- Renal or hepatic impairment
- Hematologic abnormalities as defined in protocol
- Active uncontrolled infection
NCT07218003
An Open-Label, Multicenter, Phase 1/1b Study of RNDO-564 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Relapsed/Refractory Locally Advanced or Metastatic Urothelial Cancer and Other Solid Tumors Associated With Nectin-4 Expression
Organization/Sponsor: Rondo Therapeutics
Example patient: A 62-year-old with metastatic urothelial cancer who progressed after platinum-based chemotherapy and one prior enfortumab vedotin treatment, with Grade 1 peripheral neuropathy and measurable lung metastases.
Phase 1, Phase 1b
NCT07218003
An Open-Label, Multicenter, Phase 1/1b Study of RNDO-564 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Relapsed/Refractory Locally Advanced or Metastatic Urothelial Cancer and Other Solid Tumors Associated With Nectin-4 Expression
Organization/Sponsor: Rondo Therapeutics
Example patient: A 62-year-old with metastatic urothelial cancer who progressed after platinum-based chemotherapy and one prior enfortumab vedotin treatment, with Grade 1 peripheral neuropathy and measurable lung metastases.
Phase 1, Phase 1b
Interventions
-
Biological: Pembrolizumab
Summary: Humanized monoclonal IgG4 antibody blocking PD-1 receptor to enhance T-cell-mediated immune responses against tumor cells; FDA-approved for multiple solid tumors and hematologic malignancies including urothelial cancer (FDA label, NCI Thesaurus). -
Biological: RNDO-564
Summary: Novel bispecific antibody targeting Nectin-4 and CD28 to induce tumor killing in Nectin-4 positive tumors including breast and urothelial cancers; under clinical investigation (Web Search).
Key Inclusion
- Histologically documented incurable, locally advanced or metastatic solid tumors
- Progressive disease on standard therapies or standard therapy not tolerated/declined
- Relapsed/refractory locally advanced or metastatic urothelial cancer (RR la/mUC)
- NSCLC, HNSCC, cervical cancer, gastric/GEJ cancer, esophageal cancer, or TNBC
- Up to 2 prior MMAE-containing therapies allowed if peripheral neuropathy Grade 2 or less
- Measurable disease per RECIST v1.1
- Adequate organ function
Key Exclusion
- More than one prior Nectin-4 targeted agent
- Peripheral neuropathy greater than Grade 2
- History of or active inflammatory skin disease requiring biologics or oral steroids