Clinical Trials for Bladder Cancer

Phase Ib Trial of Erdafitinib Combined With Enfortumab Vedotin Following Platinum and PD1/L1 Inhibitors for Metastatic Urothelial Carcinoma With FGFR2/3 Genetic Alterations

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: Adults with locally advanced/metastatic urothelial carcinoma harboring activating FGFR2/3 alterations after progression on platinum and a PD‑1/L1 inhibitor (including cisplatin-ineligible) receive erdafitinib (oral pan-FGFR1–4 TKI) plus enfortumab vedotin (Nectin‑4–targeted MMAE ADC). Requires measurable disease and adequate organ function; excludes prior FGFR inhibitors or enfortumab/MMAE ADCs and significant ocular/cardiovascular issues.

ClinicalTrials.gov ID: NCT04963153

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

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: 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

Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients With Nectin-4 Expressing Advanced Malignancies

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.

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 assesses BT8009, a Bicycle Toxin Conjugate targeting Nectin-4, both as monotherapy and combined with pembrolizumab, in patients with advanced Nectin-4 expressing solid tumors such as urothelial carcinoma, breast, NSCLC, and ovarian cancers, who have progressed after prior treatment or lack standard therapy options. The study evaluates safety, pharmacokinetics, and preliminary efficacy, with previously reported promising response rates in treated urothelial cancer patients.

ClinicalTrials.gov ID: NCT04561362

An Open-Label, Multiple-Dose, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VMD-928 in Subjects With Solid Tumors or Lymphoma

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.

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 advanced solid tumors or lymphoma that are refractory to standard therapies, whose tumors overexpress TrkA or harbor an NTRK1 gene fusion, to receive oral VMD-928, a highly selective irreversible TrkA inhibitor that acts via allosteric dimerization and inactivation of the target. Key exclusions include significant comorbidities and impaired drug absorption.

ClinicalTrials.gov ID: NCT03556228