A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma

ID#: NCT04740034

Age: 18 years - 66+

Gender: Male

Healthy Subjects: No

Study Phase: Phase 1

Recruitment Status: Recruiting

Start Date: April 29, 2021

End Date: September 30, 2024

Contact Information:
Amgen Call Center
866-572-6436
Summary: This is a phase 1, open-label study evaluating the safety, clinical pharmacology and clinical activity of AMG 340, a PSMA x CD3 T-cell engaging bispecific antibody, in subjects with metastatic castrate-resistant prostate cancer (mCRPC) who have received 2 or more prior lines of therapy. The study consists of 2 parts, a monotherapy dose escalation (Arm A) and a monotherapy dose expansion (Arm B). Once the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is identified in Arm A, Arm B will be initiated to further characterize the safety, tolerability and pharmacokinetic (PK) profile of the MTD/RP2D dose of AMG 340 monotherapy in subjects with mCRPC.
Eligibility:

Inclusion Criteria:

- Pathologically confirmed prostatic adenocarcinoma.

- History of metastatic disease.

- Chemically or surgically castrate.

- Subject has received at least 2 lines of systemic therapy approved for mCRPC, with disease progression on the most recent systemic therapy as defined in Prostate Cancer Working Group 3 (PCWG3) recommendations.

- HIV, HBV, and/or HCV-infected subjects that have been cured or who are on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.

- An Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.

- Subject must have adequate heart, liver, bone marrow and kidney function (e.g. eGFR ≥ 30 mL/min, AST/ALT ≤ 3 x ULN, Hgb ≥ 9 g/dL, Plt ≥ 100,000 / mm3, ANC ≥ 1500 / mm3).

Exclusion Criteria:

- Subject has been diagnosed with or treated for another malignancy whose natural history or treatment may interfere with the safety or efficacy assessment of the investigational regimen.

- History of neuroendocrine differentiation in the subject's disease.

- Subject has a history of central nervous system (CNS) involvement by their mCRPC. Metastases stemming from bone are allowed.

- Subject has clinically significant CNS pathology.

- Subject requires chronic immunosuppressive therapy.

- Subject has a history of major cardiac abnormalities.