NCT05833867

Adaptive RADiation Therapy With Concurrent Sacituzumab Govitecan (SG) for Muscle Invasive Bladder Cancer

Adaptive RADiation Therapy With Concurrent Sacituzumab Govitecan (SG) for Bladder Preservation in Patients With MIBC (RAD-SG).

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shilpa Gupta, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the safety and tolerability of treatment with concurrent Sacituzumab Govitecan (SG) and adaptive radiation therapy. The main objective is to establish the safety, tolerability, and feasibility of bladder preservation therapy treatment with concurrent SG and adaptive image-guided radiation therapy for participants with localized MIBC. Participants will receive the study drug, SG, through an IV once weekly on days 1 and 8 of each 21-day treatment cycle. The first cycle of SG will begin 21 days prior to the scheduled start of radiation therapy. The second and third cycles of SG will be given while the participant is receiving radiation therapy. Participants will be asked to undergo computed tomography (CT) and magnetic resonance imaging (MRI) pre-and post-treatment. Participation in the research will last up to 5 years, depending on treatment outcomes, with a treatment period of 8 weeks and a study follow-up period of up to 2-5 years thereafter, and a survival follow-up, with only phone call communication from years 3-5.

Detailed description

Treatment patterns in the community demonstrate that a substantial proportion of participants with bladder cancer do not receive curative intent therapy, especially if unfit for or refuse radical cystectomy. Concurrent chemoradiation is an accepted alternative to radical cystectomy, however systemic radio sensitizing chemotherapy may have significant off target side effects. This study is investigating the concurrent administration of a bladder cancer targeted antibody drug conjugate with radiotherapy. Sacituzumab govitecan (SG), or IMMU-132 is an investigational new drug that utilizes an antibody-drug conjugate (ADC) to target and kill epithelial bladder cancer cells. SG is experimental because it is not approved by the Food and Drug Administration (FDA) for use in this setting. The aim for this study is to establish the safety, tolerability, and feasibility of bladder preservation therapy treatment with concurrent SG and adaptive image-guided radiation therapy for platinum ineligible participants with localized MIBC.

Conditions

• Localized Muscle Invasive Bladder Urothelial Carcinoma
• Muscle-Invasive Bladder Carcinoma

Interventions

Type	Name	Description
DRUG	Sacituzumab govitecan	8 mg/kg Sacituzumab Govitecan is to be administered intravenously in 21-day cycles on Day 1 and Day 8; the next cycle should start a minimum of 14 days after the Day 8 dose (i.e., the Day 8 infusion will be counted as the first day of that 14-day period).
RADIATION	Adaptive Radiotherapy	Concurrently, participants will receive an individualized tailored plan for radiation therapy.

Timeline

• Start date: 2024-04-01
• Primary completion: 2026-06-01
• Completion: 2027-10-01
• First posted: 2023-04-27
• Last updated: 2026-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study