Brief Title: Study of GB-4362 With Enfortumab Vedotin and Pembrolizumab for Advanced Urothelial Cancer

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Incidence of AEs and SAEs

Primary Outcome 1 - Timeframe: From first dose of GB-4362 through 18 weeks after the last dose of GB-4362 (or prior to initiation of subsequent anti-cancer therapy

CONDITION

• Advanced Urothelial Cancer
• Metastatic Urothelial Carcinoma

ELIGIBILITY

Inclusion 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.
Exclusion Criteria
* 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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: Study Contact

Phone: (888) 5471235

Email: [email protected]

LOCATION