Clinical Trials for Bladder Cancer

NECTINIUM-2: A Phase 1b, 2 Part, Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of a Nectin-4 Radiopharmaceutical ([225Ac]Ac-AKY-1189) in Patients With Previously Treated Locally Advanced or Metastatic Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with previously treated, progressing locally advanced or metastatic urothelial cancer enter dose escalation; expansion enrolls patients with Nectin-4–positive solid tumors identified by [64Cu]Cu-AKY-1189 imaging. All receive up to six cycles of [225Ac]Ac-AKY-1189, a Nectin-4–targeted radiopharmaceutical that delivers actinium-225 to tumor cells.

ClinicalTrials.gov ID: NCT07020117

GUARDIAN-101: A Phase 1 Dose Escalation and Expansion Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with advanced or metastatic TP53 R175H-mutant solid tumors who are HLA-A*02:01-positive and have exhausted standard options receive CLSP-1025 monotherapy. This investigational T-cell engager binds CD3 and an HLA-A*02:01-presented mutant p53 peptide to direct T-cell killing of tumor cells.

ClinicalTrials.gov ID: NCT06778863

Phase 1, Open-Label, Multicenter, First-In-Human Trial of Ds-2243a in Participants With Advanced Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with previously treated, unresectable or metastatic synovial sarcoma, myxoid/round cell liposarcoma, NSCLC, or urothelial carcinoma who have an eligible HLA-A*02 subtype and ECOG 0–1 receive DS-2243a. This investigational bispecific antibody binds T cells and an NY-ESO peptide presented by HLA-A*02 on tumor cells to promote tumor killing.

ClinicalTrials.gov ID: NCT06644755

A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers (ICONIC)

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Enrolling adults with metastatic rare genitourinary cancers across multiple histologic cohorts (e.g., small cell/neuroendocrine bladder, variant urothelial, penile, sarcomatoid/unclassified RCC, collecting duct, renal medullary, urethral; including a bone-only GU cohort), with up to two prior lines allowed (cohort-specific exceptions. Patients receive cabozantinib (MET/VEGFR2/AXL multi-kinase inhibitor) plus nivolumab (PD-1) and ipilimumab (CTLA-4) for up to 2 years.

ClinicalTrials.gov ID: NCT03866382

A Phase I/Ib Open Label, Single-Arm Study of Cabozantinib in Combination with Enfortumab Vedotin (EV) in the Treatment of Locally Advanced or Metastatic Urothelial Cancer

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with unresectable locally advanced or metastatic urothelial carcinoma after prior PD-1/PD-L1 therapy (and prior platinum or platinum-ineligible), ECOG 0–2, receive enfortumab vedotin (anti–Nectin-4 ADC delivering MMAE) plus cabozantinib (multikinase inhibitor of MET/VEGFR/AXL) until progression/toxicity. Excludes prior EV/MMAE or cabozantinib, significant cardiovascular/GI risks, untreated/unstable CNS disease, and grade ≥2 neuropathy.

ClinicalTrials.gov ID: NCT04878029

A Phase 1 Dose-Escalation and Expansion Study Evaluating the Safety, Efficacy, and Pharmacokinetics of EVOLVE104 in Subjects With Advanced Urothelial and Squamous Cell Carcinomas

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with measurable, locally advanced or metastatic bladder cancer or squamous cell carcinoma of the lung, esophagus, skin, or anogenital region, generally after standard therapy, receive EVOLVE104 monotherapy. This investigational trispecific T-cell engager binds tumor-cell ULBP2/5/6 and T-cell CD3 and CD2 to promote T-cell killing with CD2 costimulation.

ClinicalTrials.gov ID: NCT07217171

A Multi-Center, Open Label, Phase 1/2 Study of CP-383, in Patients With Advanced or Metastatic Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Patients with incurable locally advanced, recurrent, or metastatic solid tumors who lack appropriate standard treatment receive once-daily oral CP-383, an investigational dual DHODH/TEAD4 inhibitor. Dose expansion focuses on selected cancers, including colorectal, small-cell lung, and head and neck cancers, with some cohorts defined by tumor alterations.

ClinicalTrials.gov ID: NCT07030257

A Phase 1 Open-label Study to Investigate PF-08046876 in Adult Participants With Advanced Solid Tumors.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with measurable advanced bladder, lung, head and neck, esophageal, or pancreatic cancer and ECOG 0–1 receive intravenous PF-08046876, an antibody–drug conjugate targeting integrin beta-6 that delivers a camptothecin-class topoisomerase I inhibitor. Dose escalation requires progression after standard therapy; dose optimization and expansion cohorts allow up to two prior systemic therapy lines for advanced disease.

ClinicalTrials.gov ID: NCT07090499

A First-in-human, Phase I, Multi-center, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Evidence of Antitumor Activity of IDOV-Immune in Adult Participants With Advanced Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with measurable advanced solid tumors that have progressed after standard therapy or lack a standard treatment option receive a single intravenous infusion of IDOV-Immune. This engineered oncolytic vaccinia virus is designed to replicate preferentially in tumor cells, destroy them, and stimulate antitumor immunity.

ClinicalTrials.gov ID: NCT06910657

Combinations of Sacituzumab Govitecan Plus Enfortumab Vedotin and Pembrolizumab for Metastatic Urothelial Carcinoma: the Double Antibody Drug Conjugate (DAD) and Double Antibody Drug Conjugate With Immunotherapy (DAD-IO) Phase I/II Trial

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with metastatic urothelial carcinoma: refractory cohort includes patients progressing after platinum (if eligible) and prior PD-1/L1 therapy; first-line cohort includes treatment‑naive mUC (prior perioperative therapy allowed, prior IO >6 months). Treatments are enfortumab vedotin (anti–Nectin-4 ADC with MMAE) plus sacituzumab govitecan (anti–Trop-2 ADC with SN‑38) for refractory disease, and the same doublet plus pembrolizumab (anti–PD‑1) for first line.

ClinicalTrials.gov ID: NCT04724018