Clinical Trials for Bladder Cancer

A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

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.

TrialFetch AI summary: Patients with previously treated, locally advanced or metastatic TP53 Y220C–mutant solid tumors and ECOG performance status 0–1 may be eligible; the enrolling portion requires measurable disease and excludes tumors with a KRAS single-nucleotide variant. Participants receive oral rezatapopt, an investigational small molecule that stabilizes Y220C-mutant p53 to restore tumor-suppressor activity; earlier cohorts also evaluated rezatapopt with pembrolizumab.

ClinicalTrials.gov ID: NCT04585750

A Phase 1/1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 relapsed or refractory, unresectable locally advanced or metastatic solid tumors, including metastatic castration-resistant prostate cancer, receive MGC026 intravenously every 21 days in dose-escalation or expansion cohorts. MGC026 is a B7-H3–targeting antibody–drug conjugate carrying an exatecan-based topoisomerase I inhibitor payload.

ClinicalTrials.gov ID: NCT06242470

A Phase I/II Study of VLS-1488 (an Oral KIF18A Inhibitor) in Subjects With Advanced Cancer

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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, ECOG 0–1, and limited treatment options receive oral VLS-1488 monotherapy; eligible cancers include high-grade serous ovarian, squamous non-small cell lung, triple-negative breast, and selected gastrointestinal, head and neck, and gynecologic tumors. VLS-1488 inhibits KIF18A, a mitotic kinesin involved in chromosome alignment.

ClinicalTrials.gov ID: NCT05902988

PROGRESS: Precision Oncology Using Genomic Reflexive Evaluations for Study Selection and Survival

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

TrialFetch AI summary: This trial enrolls adults with stage IV solid tumors—including NSCLC, colorectal, breast, or bladder cancer—who are candidates for NGS testing prior to first or second-line metastatic therapy, and evaluates centralized precision oncology navigation and expert NGS review to increase use of existing targeted therapies and biomarker-driven clinical trial referrals. No investigational drugs are provided; the study focuses on optimizing precision oncology care using standard of care treatments.

ClinicalTrials.gov ID: NCT06896162

A Phase 1 Dose-Escalation and Expansion Study of Intratumorally Administered ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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: For adults with progressing, unresectable or recurrent advanced solid tumors or lymphomas who have no remaining standard treatment options and at least one injectable, measurable lesion, this study evaluates intratumoral ONM-501 alone or with cemiplimab. ONM-501 is an investigational STING-directed immunotherapy designed to enhance intracellular cGAMP delivery and sustain STING activation; cemiplimab inhibits PD-1.

ClinicalTrials.gov ID: NCT06022029

A Phase 1a/1b Study of BG-68501, a Selective CDK2 Inhibitor, in Participants With Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 advanced solid tumors may receive the oral selective CDK2 inhibitor BG-68501 alone; expansion cohorts focus on HR-positive/HER2-negative breast cancer and platinum-resistant or -refractory serous ovarian, fallopian tube, or primary peritoneal cancer. Breast cancer cohorts also evaluate BG-68501 with fulvestrant, with or without the investigational selective CDK4 inhibitor BGB-43395.

ClinicalTrials.gov ID: NCT06257264

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

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 high-risk non–muscle-invasive bladder cancer who are not undergoing radical cystectomy receive intravesical PF-08052667, an investigational integrin β6–targeted antibody–drug conjugate, alone or with intravesical BCG and/or subcutaneous sasanlimab, an anti–PD-1 antibody. Cohorts include patients with persistent or recurrent disease after BCG and some previously untreated patients.

ClinicalTrials.gov ID: NCT07206225

A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE892 as Monotherapy and Combination Therapy in Participants With MTAP-Deleted Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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, measurable MTAP-deleted advanced solid tumors (ECOG 0–1) receive oral IDE892 alone or with IDE397; dose-expansion cohorts are limited to NSCLC. IDE892 is an MTA-cooperative PRMT5 inhibitor, and IDE397 is a MAT2A inhibitor.

ClinicalTrials.gov ID: NCT07277413

AN INTERVENTIONAL PHASE 1B/2, OPEN-LABEL STUDY TO INVESTIGATE THE SAFETY, ANTITUMOR ACTIVITY, AND PHARMACOKINETICS OF PF 08634404 MONOTHERAPY OR IN COMBINATION WITH ENFORTUMAB VEDOTIN IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 urothelial carcinoma and ECOG performance status 0–1 receive PF-08634404 alone if previously treated, or PF-08634404 plus enfortumab vedotin if untreated for advanced disease. PF-08634404 is an investigational bispecific antibody targeting PD-1 and VEGF.

ClinicalTrials.gov ID: NCT07421700

A Phase Ib/II Study to Evaluate the Safety and Efficacy of Enfortumab Vedotin Plus Pembrolizumab in Combination With Quemliclustat in Unresectable Locally Advanced and Metastatic Urothelial Carcinoma

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 untreated, measurable, unresectable locally advanced or metastatic urothelial carcinoma receive enfortumab vedotin plus pembrolizumab with investigational quemliclustat, a CD73 inhibitor intended to reduce immunosuppressive adenosine in the tumor microenvironment.

ClinicalTrials.gov ID: NCT07667335