Clinical Trials for Bladder Cancer

A Randomized Open-Label Phase 2/3 Study of BT8009 as Monotherapy or in Combination in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)

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.

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.

No known activity

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

HealthScout AI summary: Adults with unresectable locally advanced or metastatic urothelial carcinoma (bladder, ureter, renal pelvis, or urethra) are randomized to BT8009, a Nectin‑4–targeted Bicycle Toxin Conjugate delivering MMAE, as monotherapy (post‑platinum, no prior MMAE) or BT8009 plus pembrolizumab in the first-line setting, versus standard platinum-based chemotherapy with optional avelumab maintenance. Key cohorts include first-line, platinum-eligible patients and previously treated patients with progression after ≥1 systemic regimen.

ClinicalTrials.gov ID: NCT06225596

A Multicenter, Open-label Phase 1/2 Study of TYRA300 in Advanced Urothelial Carcinoma and Other Solid Tumors With Activating FGFR3 Gene Alterations (SURF301)

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.

HealthScout AI summary: Adults with advanced urothelial carcinoma or other solid tumors harboring activating FGFR3 mutations or fusions receive oral TYRA-300 (dabogratinib), a highly selective FGFR3 tyrosine kinase inhibitor designed to spare FGFR1/2/4 and retain activity against FGFR3 gatekeeper mutations (e.g., V555M). Phase 2 includes cohorts post–FGFR inhibitor with resistance/kinase domain mutations, FGFR inhibitor–naïve urothelial carcinoma, and other FGFR3-altered solid tumors.

ClinicalTrials.gov ID: NCT05544552

An Open Label, Phase 1, Treatment Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of IDE397 (MAT2A Inhibitor) In Adult 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.

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.

HealthScout AI summary: This trial evaluates the safety and preliminary anti-tumor activity of IDE397, a MAT2A inhibitor, in adult patients with MTAP-deleted advanced solid tumors, either as monotherapy or in combination with docetaxel, paclitaxel, or sacituzumab govitecan. Eligible patients must have advanced or metastatic solid tumors that have failed at least one prior treatment line.

ClinicalTrials.gov ID: NCT04794699

A Phase 1/2, Open-label, Dose-escalation, and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Therapeutic Activity of GI-101 As a Single Agent and in Combination with Pembrolizumab, Lenvatinib or Local Radiotherapy in Patients with Advanced or Metastatic Solid Tumors (Keynote B59)

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.

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.

HealthScout AI summary: This trial involves adult patients with advanced or metastatic solid tumors and evaluates the safety and therapeutic activity of GI-101, a bispecific fusion protein targeting CTLA-4 and the IL-2 pathway, as a single agent and in combination with pembrolizumab, lenvatinib, or radiotherapy.

ClinicalTrials.gov ID: NCT04977453

Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT5528 in Patients With Advanced Malignancies Associated With EphA2 Expression

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.

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.

HealthScout AI summary: This trial involves patients over 18 with advanced solid tumors expressing high levels of EphA2, testing the safety and efficacy of BT5528, a targeted Bicycle Toxin Conjugate linked to MMAE, as a monotherapy and in combination with the PD-1 inhibitor nivolumab, particularly in ovarian, urothelial, lung, breast, head and neck, and gastric cancers after progression on standard treatments.

ClinicalTrials.gov ID: NCT04180371

A Phase 1/2, First-in-Human, Open Label, Dose Escalation and Expansion Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic 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.

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.

HealthScout AI summary: Adult patients with unresectable locally advanced or metastatic solid tumors (including melanoma, renal cell carcinoma, or PD-L1-positive NSCLC) who have progressed after or are ineligible for standard therapies receive AU-007, a novel monoclonal antibody that redirects IL-2 activity toward effector T and NK cells by blocking IL-2Rα, as monotherapy or in combination with recombinant IL-2 and/or checkpoint inhibitors. Patients must have adequate organ function, resolved prior immunotherapy toxicity, and measurable or evaluable disease.

ClinicalTrials.gov ID: NCT05267626

A Phase 1 Study of SGN-B6A in 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.

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.

HealthScout AI summary: This trial enrolls adults with metastatic or unresectable solid tumors (including NSCLC, HNSCC, HER2-negative breast, esophageal, cutaneous SCC, ovarian, bladder, cervical, pancreatic, and gastric cancers), evaluating the antibody-drug conjugate sigvotatug vedotin—targeting integrin beta-6—with or without pembrolizumab and/or platinum chemotherapy. Eligibility varies by cohort, including both treatment-naïve and previously treated/refractory patients, with fresh or recent tumor biopsy required in some arms.

ClinicalTrials.gov ID: NCT04389632

A Pilot Study of Spatially Fractionated Radiation Therapy in Patients with Extra-Cranial Soft Tissue Metastases

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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic solid tumors and at least two extracranial soft tissue metastases (one ≥4 cm) requiring palliative radiation, comparing lattice radiation therapy (LRT)—a spatially fractionated radiotherapy technique that may enhance immune effects—to standard SBRT, with each patient receiving both treatments at different sites.

ClinicalTrials.gov ID: NCT05837767

A Phase I Dose Escalation / Dose Expansion Study of NBTXR3 Activated by Radiotherapy for Patients with Advanced Cancers Treated with an Anti-PD-1 Therapy

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.

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.

HealthScout AI summary: This trial enrolls patients with advanced, injectable metastatic or recurrent head and neck squamous cell carcinoma, NSCLC, melanoma, hepatocellular, renal, urothelial, cervical, or triple-negative breast cancer—regardless of anti-PD-1 status—to receive a single intratumoral injection of NBTXR3 (a hafnium oxide nanoparticle radioenhancer) activated by SABR, followed by anti-PD-1 therapy with nivolumab or pembrolizumab.

ClinicalTrials.gov ID: NCT03589339

A First in Human Phase I Trial of Binary Oncolytic Adenovirus in Combination With HER2-Specific Autologous CAR T Cells in Patients With Advanced HER2 Positive 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.

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.

HealthScout AI summary: Eligible adult patients have advanced, refractory HER2-positive solid tumors with at least one injectable lesion. The trial evaluates safety and preliminary efficacy of intratumoral CAdVEC, an oncolytic adenovirus expressing IL-12 and a PD-L1 blocker, alone or in combination with intravenous HER2-specific autologous CAR T cells at higher dose levels.

ClinicalTrials.gov ID: NCT03740256