Sacituzumab Govitecan for Metastatic Castration-Resistant Prostate Cancer

Recruiting at 2 trial locations

Overseen By Cancer Connect

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University of Wisconsin, Madison

Must be taking: Enzalutamide, Darolutamide, Apalutamide, Abiraterone

Must not be taking: Cytotoxic chemotherapy, Herbal products

Disqualifiers: CNS metastases, Cardiac arrhythmias, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 9 weeks

31 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will investigate the safety and efficacy of Sacituzumab Govitecan in patients with metastatic castration-resistant prostate cancer progressing on second generation androgen receptor (AR) directed therapy (e.g., enzalutamide, darolutamide, apalutamide and/or abiraterone).

Research Team

Joshua Lang, MD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

Men over 18 with advanced prostate cancer that's resistant to hormone therapy and has worsened despite treatment like enzalutamide or abiraterone. They should have no other recent cancers, not had certain treatments recently, and must be in fairly good health with stable heart conditions. Participants need a biopsy available from their cancer and agree to use two forms of birth control if applicable.

Inclusion Criteria

Subjects who have partners of child-bearing potential must be willing to use at least two forms of effective birth control (one form must be a barrier method) during the treatment period and for 90 days after last dose of IMMU-132. Subjects must also agree to not donate sperm through 90 days following the last dose of IMMU-132.

Subjects must be willing and able (in the opinion of the treating physician) to undergo one research biopsy for the investigational component of this study

I have had surgery to remove my testicles or have been on hormone therapy for prostate cancer for at least 3 months.

Exclusion Criteria

I don't have serious heart rhythm problems or I have a pacemaker if I do.

I have not had a recent heart attack or severe heart failure in the last 6 months.

I do not have active HIV, Hepatitis B, or Hepatitis C infections.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Sacituzumab Govitecan in addition to their single agent Androgen Receptor Signaling Inhibitors for Castrate-Resistant Prostate Cancer. Treatment is administered on days 1 and 8 in a 21-day cycle, with a minimum of 3 cycles.

9 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including PSA response and progression-free survival.

6 months

Long-term Follow-up

Participants are monitored for progression-free survival and overall survival.

Up to 2 years

Treatment Details

Interventions

• IMMU-132

Trial Overview The trial is testing Sacituzumab Govitecan for safety and effectiveness in men whose prostate cancer has spread and isn't responding to second-generation AR-directed therapies. The study includes those who've progressed on drugs such as enzalutamide or abiraterone.

Participant Groups

Group I: Sacituzumab Govitecan Treatment Experimental Treatment 1 Intervention

Subjects enrolled in this study will receive Sacituzumab Govitecan in addition to their single agent Androgen Receptor Signaling Inhibitors (ARSI) as treatment for Castrate-Resistant Prostate Cancer. Dose will be calculated per protocol in milligrams based on the subject's body weight at the beginning of each cycle or more frequently if weight changes \>10%. Subjects will be treated on days 1 and 8 in a 21-day cycle, minimum 3 cycles.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Gilead Sciences

Industry Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine