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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Sacituzumab Govitecan (also known as IMMU-132) for individuals with a type of prostate cancer that no longer responds to hormonal therapy. The main goal is to assess the safety and effectiveness of this drug when combined with existing treatments. The trial seeks participants whose prostate cancer has spread and continues to grow despite current medication. Those whose cancer has progressed on drugs like enzalutamide or abiraterone may be suitable for this study. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Is there any evidence suggesting that Sacituzumab Govitecan is likely to be safe for humans?

Research has shown that Sacituzumab Govitecan generally has a manageable safety profile in cancer treatments. In earlier studies, patients experienced side effects similar to those of chemotherapy, which were considered manageable. The treatment was tested in various cancer types and showed consistent results.

Sacituzumab Govitecan is currently undergoing testing for advanced prostate cancer that no longer responds to hormone therapy. Although this specific trial is still ongoing, previous research provides some reassurance about its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Sacituzumab Govitecan is unique because it combines an antibody with a chemotherapy drug to specifically target and destroy cancer cells in metastatic castration-resistant prostate cancer. Unlike standard treatments that primarily focus on blocking androgen receptors, Sacituzumab Govitecan works by delivering a potent chemotherapy agent directly to the cancer cells, potentially reducing damage to healthy cells. Researchers are excited about this treatment because its targeted approach could lead to more effective results and fewer side effects compared to existing therapies.

What evidence suggests that Sacituzumab Govitecan might be an effective treatment for metastatic castration-resistant prostate cancer?

Research has shown that Sacituzumab Govitecan, which participants in this trial will receive, yields promising results in treating various types of cancer. Studies have found it effective for several cancers, including endometrial and small-cell lung cancer. For prostate cancer, particularly in patients whose disease persists despite treatment, one study showed partial improvement. This treatment targets a protein called Trop-2, present on many cancer cells, allowing it to deliver cancer-fighting drugs directly to the tumor. This targeted approach offers a potential option for patients whose cancer hasn't responded to other treatments. ^{1 2 3 4 6}

Who Is on the Research Team?

Joshua Lang, MD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. annalsofoncology.org annalsofoncology.org/article/S0923-7534(22)03743-7/fulltext

1406P Interim results of a phase II trial of sacituzumab ... Twenty pts were enrolled in this Phase II trial at the time of interim analysis. Pts had a median PSA of 47.2ng/mL at baseline. All pts had metastatic disease, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03725761

Study Details | NCT03725761 | Sacituzumab Govitecan in ... This study will investigate the safety and efficacy of Sacituzumab Govitecan in patients with metastatic castration-resistant prostate cancer progressing on ...

3. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.2020.38.6_suppl.TPS251

Prostate Cancer - Advanced The primary endpoint is PSA response rate (≥50% PSA decline at or within 9 weeks of starting treatment); secondary endpoints include rPFS and ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33741442/

Sacituzumab govitecan, a Trop-2-directed antibody-drug ... Partial responses were seen in endometrial cancer (4/18, 22.2% ORR) and small-cell lung cancer (11/62, 17.7% ORR), and one castrate-resistant prostate cancer ...

5. bjmo.be bjmo.be/sacituzumab-govitecan-efficacious-in-additional-cancers-updated-efficacy-and-safety-results-from-the-phase-i-ii-immu-132-01-trial/

Sacituzumab govitecan efficacious in additional cancers In an updated analysis of this trial, SG was found to have manageable adverse events comparable to chemotherapy, and showed efficacy in colorectal, endometrial, ...

6. aacrjournals.org aacrjournals.org/cancerres/article/83/11_Supplement/B016/726782/Abstract-B016-Liquid-biopsy-biomarker-analysis-of

Abstract B016: Liquid biopsy biomarker analysis of a phase II ... Liquid biopsy biomarker analysis of a phase II trial of sacituzumab govitecan in castrate resistant metastatic prostate cancer [abstract].