Clinical Trials for Bladder Cancer

A Phase 2 Open-label Basket Study to Evaluate the Efficacy and Safety of Orally Administered Reversible Tyrosine Kinase Inhibitor BAY 2927088 in Participants With Metastatic or Unresectable Solid Tumors With HER2-activating Mutations

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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.

TrialFetch AI summary: Adults with unresectable or metastatic solid tumors other than NSCLC that harbor an activating HER2 mutation are eligible after appropriate standard therapy or when no satisfactory alternative exists; prior HER2 tyrosine kinase inhibitor treatment and active brain metastases are excluded. All participants receive oral sevabertinib, a reversible HER2-directed tyrosine kinase inhibitor, 20 mg twice daily.

ClinicalTrials.gov ID: NCT06760819

A Randomized, Open-Label, Phase 2/3 Study of Datopotamab Deruxtecan (Dato-DXd) Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) Who Progressed During or After Enfortumab Vedotin (EV) Plus Pembrolizumab Combination Treatment TROPION-Urothelial03 (TU03)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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.

TrialFetch AI summary: Adults with unresectable locally advanced or metastatic urothelial carcinoma that progressed during or after first-line enfortumab vedotin plus pembrolizumab, and who are eligible for cisplatin or carboplatin, receive datopotamab deruxtecan plus platinum or gemcitabine plus platinum. Datopotamab deruxtecan is a TROP2-directed antibody–drug conjugate that delivers a topoisomerase I inhibitor.

ClinicalTrials.gov ID: NCT07129993

FORAGER-2: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Vepugratinib Combined With Enfortumab Vedotin and Pembrolizumab in Adults With Untreated Locally Advanced or Metastatic Urothelial Carcinoma With an FGFR3 Genetic Alteration

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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.

TrialFetch AI summary: Adults with previously untreated, unresectable locally advanced or metastatic urothelial carcinoma harboring an FGFR3 alteration receive first-line enfortumab vedotin and pembrolizumab plus either vepugratinib or placebo. Vepugratinib is an investigational FGFR3-selective inhibitor.

ClinicalTrials.gov ID: NCT07218380

A Phase 3, Randomized, Open-label Study of Sacituzumab Tirumotecan (MK-2870) Versus Investigator's Choice of Non-platinum Chemotherapy in Participants With Pretreated Locally Advanced/Metastatic Urothelial Carcinoma

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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.

TrialFetch AI summary: Patients with unresectable locally advanced or metastatic urothelial carcinoma progressing after anti-PD-(L)1 therapy, platinum chemotherapy, and enfortumab vedotin (or disitamab vedotin in China) are randomized to sacituzumab tirumotecan or investigator’s choice of paclitaxel, docetaxel, or vinflunine. Sacituzumab tirumotecan is a TROP2-directed antibody–drug conjugate that delivers a topoisomerase I inhibitor.

ClinicalTrials.gov ID: NCT07419295

HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects With Locally Advanced or Metastatic Solid Tumors

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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 ECOG 0–1 and previously treated, refractory, locally advanced unresectable or metastatic solid tumors across multiple tumor-specific cohorts receive patritumab deruxtecan 5.6 mg/kg IV every 3 weeks. This investigational HER3-targeted antibody–drug conjugate delivers an exatecan-derived topoisomerase I inhibitor payload.

ClinicalTrials.gov ID: NCT06172478

A Phase 2 Master Protocol to Assess the Efficacy and Safety of FORE8394, an Inhibitor of BRAF Class 1 and Class 2 Alterations, in Participants With Cancer Harboring BRAF Alterations

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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 aged ≥10 years with advanced solid tumors or recurrent or progressive primary CNS tumors harboring eligible BRAF fusions or BRAF V600E mutations receive plixorafenib, an oral inhibitor of BRAF V600 signaling and BRAF-containing dimers. Depending on the tumor cohort, plixorafenib is given alone or with cobicistat to increase plixorafenib exposure; patients with metastatic cutaneous melanoma or thyroid cancer are randomized between these regimens.

ClinicalTrials.gov ID: NCT05503797

A Phase 2 Multi-Cohort, Open-Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48-ADC) Alone or in Combination With Pembrolizumab in Subjects With Locally-Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

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

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: For patients with measurable, locally advanced unresectable or metastatic urothelial carcinoma, generally with HER2 expression (IHC 1+ to 3+), cohorts include previously treated patients and untreated platinum-eligible patients. Treatment is disitamab vedotin, an investigational HER2-directed antibody–drug conjugate that delivers the microtubule inhibitor MMAE, alone or with the PD-1 inhibitor pembrolizumab.

ClinicalTrials.gov ID: NCT04879329

A Phase 1a/1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Advanced or Metastatic Urothelial Carcinoma or Other 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: Patients with advanced or metastatic urothelial carcinoma after at least one prior regimen, including those previously treated with enfortumab vedotin, or selected other solid tumors after standard options are exhausted receive intravenous LY4052031. This investigational Nectin-4–targeted antibody–drug conjugate delivers a topoisomerase I inhibitor payload.

ClinicalTrials.gov ID: NCT06465069

A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors

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: Adults with measurable, locally advanced or metastatic solid tumors and ECOG performance status 0–1 receive MDNA11 alone or with pembrolizumab. MDNA11 is a long-acting IL-2 agonist designed to favor IL-2 receptor β signaling in CD8-positive T cells and natural killer cells while limiting regulatory T-cell stimulation; pembrolizumab blocks PD-1.

ClinicalTrials.gov ID: NCT05086692

A Phase 1/1b Study of IAM1363 in Patients with Advanced Cancers Harboring HER2 Alterations

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 HER2-altered advanced cancers after progression on or intolerance of their last systemic therapy receive oral IAM1363, an investigational irreversible HER2 inhibitor designed to penetrate the brain. Patients with brain metastases may enroll unless they need immediate local therapy.

ClinicalTrials.gov ID: NCT06253871