BridgeMD
New treatment option for Advanced Urothelial Cancer
Official title Study of GB-4362 With Enfortumab Vedotin and Pembrolizumab for Advanced Urothelial Cancer
ClinicalTrials.gov ID: NCT07484022
What this study is testing
What is GB-4362?
GB-4362 is an investigational medicine, being studied as a potential treatment for advanced urothelial cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the safety and tolerability of an investigational drug called GB-4362 when it is given together with enfortumab vedotin and pembrolizumab in adults with advanced or metastatic urothelial cancer. GB-4362 is a monoclonal antibody designed to bind and neutralize free monomethyl auristatin E (MMAE), a chemotherapy payload released from enfortumab vedotin that is associated with side effects such as peripheral neuropathy.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Planned to receive standard-of-care treatment with enfortumab vedotin (EV) (starting dose 1.25 mg/kg) in combination with pembrolizumab for locally...
- Age ≥18 years.
- ECOG Performance Status score of 0 or 1 (ECOG 2 excluded in Dose Escalation but allowed in Dose Expansion).
- Weight ≥50 kg at screening.
- Life expectancy ≥3 months, as determined by the investigator.
You likely can't join if
- Previously received enfortumab vedotin (EV) or other MMAE-based antibody-drug conjugates (ADCs).
- Received anti-cancer treatment with chemotherapy, biologics, or investigational agents within 4 weeks before the first dose of EV/pembrolizumab.
- Uncontrolled diabetes.
- Active CNS metastases. Participants with treated CNS metastases are permitted if all of the following criteria are met:
- CNS metastases have been clinically stable for at least 4 weeks prior to screening and baseline scans show no evidence of new or enlarged metastasis.
- The participant is on a stable dose of ≤10 mg/day of prednisone or equivalent for at least 2 weeks (if requiring steroid treatment).
See the full eligibility criteria
- Planned to receive standard-of-care treatment with enfortumab vedotin (EV) (starting dose 1.25 mg/kg) in combination with pembrolizumab for locally advanced or metastatic urothelial cancer.
- Age ≥18 years.
- ECOG Performance Status score of 0 or 1 (ECOG 2 excluded in Dose Escalation but allowed in Dose Expansion).
- Weight ≥50 kg at screening.
- Life expectancy ≥3 months, as determined by the investigator.
- Participants must provide written informed consent before any study-related activities are carried out and must be able to understand the nature and purpose of the study, including potential risks and adverse effects.
- Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
- Previously received enfortumab vedotin (EV) or other MMAE-based antibody-drug conjugates (ADCs).
- Received anti-cancer treatment with chemotherapy, biologics, or investigational agents within 4 weeks before the first dose of EV/pembrolizumab.
- Uncontrolled diabetes.
- Active CNS metastases. Participants with treated CNS metastases are permitted if all of the following criteria are met:
- CNS metastases have been clinically stable for at least 4 weeks prior to screening and baseline scans show no evidence of new or enlarged metastasis.
- The participant is on a stable dose of ≤10 mg/day of prednisone or equivalent for at least 2 weeks (if requiring steroid treatment).
- The participant does not have leptomeningeal disease.
- Ongoing clinically significant toxicity associated with prior treatment (including radiotherapy or surgery) that has not resolved to Grade ≤1 or returned to baseline.
- History of a severe (Grade ≥3) allergic or infusion-related reaction to any monoclonal antibody.
- Another underlying medical condition that, in the opinion of the investigator, would impair the ability of the participant to receive or tolerate the planned treatment and follow-up.
- Known psychiatric or substance abuse disorders that would interfere with cooperating with study requirements
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Irvine, California, United States
- Orlando, Florida, United States
- Tucker, Georgia, United States
- Zion, Illinois, United States
- New Brunswick, New Jersey, United States
- Lake Success, New York, United States
- New York, New York, United States
- Houston, Texas, United States
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Irvine, California, United States; Orlando, Florida, United States; Tucker, Georgia, United States; Zion, Illinois, United States; New Brunswick, New Jersey, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.