Safety, Tolerability, Pharmacokinetics, and Efficacy of Acapatamab in Subjects With mCRPC

Recruiting at 30 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Amgen

Must be taking: GnRH agonist/antagonist

Must not be taking: Strong OAT3 inhibitors

Disqualifiers: CNS metastases, Autoimmune disease, Cardiac arrhythmia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 3 years

212 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new drug called acapatamab, which helps the immune system target and kill advanced prostate cancer cells that don't respond to hormone treatments.

Will I have to stop taking my current medications?

The trial requires that you stop any anticancer therapy or immunotherapy at least 4 weeks before starting the study, except for certain hormone therapies. If you are on chronic systemic corticosteroid therapy, you need to stop it 7 days before the first dose.

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

Inclusion Criteria

- nodal or visceral progression as defined by RECIST 1.1 with PCGW3 modifications

Subjects with histologically or cytologically confirmed mCRPC who are refractory to a novel antiandrogen therapy (abiraterone, enzalutamide, and/or apalutamide) and have failed at least 1 (but not more than 2) taxane regimens (or who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen). Progression on novel antiandrogen therapy may have occurred in the non-metastatic CRPC setting

Subject has provided informed consent prior to initiation of any study specific activities/procedures

Exclusion Criteria

Prior PSMA-targeted therapy (subjects on prior therapy may be eligible if discussed with Amgen medical monitor prior to enrollment)

Needing chronic systemic corticosteroid therapy (prednisone > 10 mg per day or equivalent) or any other immunosuppressive therapies (including anti-tumor necrosis factor alpha [TNF alpha] therapies) unless stopped 7 days prior to start of first dose

Any anticancer therapy or immunotherapy within 4 weeks of start of first dose, not including luteinizing hormone-releasing hormone agonist (LHRH)/GnRH analogue (agonist/antagonist). Subjects on a stable bisphosphonate or denosumab regimen for >/= 30 days prior to randomization are eligible

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-exploration

Acapatamab is administered intravenously to estimate the maximum tolerated dose (MTD) and identify the recommended phase 2 dose (RP2D) based on emerging safety, efficacy, and pharmacodynamic data.

Up to 3 years

Treatment

Participants receive acapatamab alone or in combination with pembrolizumab, etanercept prophylaxis, or CYP phenotyping cocktail, with monitoring for safety and efficacy.

Up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of prostate-specific antigen (PSA) response and progression-free survival.

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Acapatamab

How Is the Trial Designed?

Group I: Part 6: acapatamab + Cytochrome P450 (CYP) Cocktail Drug Interaction Experimental Treatment 2 Interventions

Part 6: acapatamab is administered intravenously at RP2D/MTD. A CYP phenotyping cocktail will be administered orally.

Group II: Part 5: acapatamab Outpatient Cohort Experimental Treatment 1 Intervention

Part 5: acapatamab is administered intravenously at RP2D/MTD in an outpatient setting with 8-hour monitoring.

Group III: Part 4: acapatamab 24 Hour Monitoring Experimental Treatment 1 Intervention

Part 4: acapatamab is administered intravenously at RP2D/MTD with 24-hour monitoring.

Group IV: Part 3: acapatamab + Etanercept Prophylaxis Experimental Treatment 2 Interventions

Part 3: acapatamab is administered intravenously at RP2D/MTD levels. Etanercept will be administered subcutaneously in cycle 1 only.

Group V: Part 2: acapatamab + Pembrolizumab Experimental Treatment 2 Interventions

Part 2: acapatamab is administered intravenously at the MTD/RP2D. Pembrolizumab will be administered intravenously.

Group VI: Part 1 Dose-exploration: acapatamab treatment Experimental Treatment 1 Intervention

Part 1 dose-exploration: acapatamab is administered intravenously. The dose-exploration phase of the study will estimate the MTD of acapatamab. RP2D may be identified based on emerging safety, efficacy, and pharmacodynamic data prior to reaching an MTD.

Group VII: Part 1 Dose-expansion: acapatamab treatment Experimental Treatment 1 Intervention

Part 1 dose-expansion: acapatamab is administered intravenously at the MTD/RP2D.

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London