ARV-110 + Abiraterone for Prostate Cancer

Recruiting at 19 trial locations

Overseen By Arvinas Androgen Receptor, Inc.

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Arvinas Androgen Receptor, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

Phase 1b study to assess the combination of ARV-110 and abiraterone in patients with metastatic prostate cancer with rising PSA values on abiraterone.

Eligibility Criteria

Men with metastatic castration-resistant prostate cancer who have rising PSA levels despite ongoing abiraterone treatment. They should be in good physical condition (ECOG status of 0 or 1) and on stable hormone therapy. Excluded are those with recent major surgery, uncontrolled infections, severe heart conditions, electrolyte imbalances, brain metastases requiring steroids, or other active cancers.

Inclusion Criteria

My PSA levels have increased 16 weeks after starting abiraterone.

My PSA levels have increased 16 weeks after starting abiraterone.

I am currently on stable doses of abiraterone and a steroid for my metastatic prostate cancer.

Exclusion Criteria

Patients with QTcF ≥470 msec.

I do not have any active, uncontrolled infections including HIV/AIDS or hepatitis.

Patients with electrolyte imbalances of hypokalemia, hypomagnesemia, and/or hypocalcemia

Treatment Details

Interventions

• Abiraterone (Androgen Synthesis Inhibitor)
• ARV-110 (Androgen Receptor Degrader)

Trial Overview The trial is testing the combination of a new drug called ARV-110 with an existing medication named Abiraterone to see if it can help men whose prostate cancer continues to progress as indicated by rising PSA levels even after being treated with Abiraterone alone.

Participant Groups

Group I: Oral tablet(s) in combination with abiraterone and a corticosteroid. Experimental Treatment 1 Intervention

ARV-110 oral tablets in combination with abiraterone and a corticosteroid administered daily in 28 day cycles.

Abiraterone is already approved in Canada, Japan for the following indications:

Approved in Canada as Zytiga for:

• Metastatic castration-resistant prostate cancer (mCRPC)
• Metastatic high-risk castration-sensitive prostate cancer (mCSPC)

Approved in Japan as Zytiga for:

• Metastatic castration-resistant prostate cancer (mCRPC)
• Metastatic high-risk castration-sensitive prostate cancer (mCSPC)

Who Is Running the Clinical Trial?

Arvinas Androgen Receptor, Inc.

Lead Sponsor

Trials

4

Recruited

450+