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

NCT03792841 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2025-10-16

No results posted yet for this study

Summary

A phase 1 study evaluating the safety, tolerability, pharmacokinetics, and efficacy of prostate specific membrane antigen half-life extended bispecific T-cell engager acapatamab in subjects with metastatic castration-resistant prostate cancer, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).

Conditions

Interventions

DRUG

acapatamab

Investigational immunotherapy for the treatment of metastatic castration-resistant prostate cancer

DRUG

Pembrolizumab

Combined with acapatamab for investigational treatment of mCRPC

DRUG

Etanercept

Prophylaxis for acapatamab-related cytokine release syndrome.

DRUG

Cytochrome P450 (CYP) Cocktail

Evaluate the effect of co-administration of multiple dosing of acapatamab on plasma

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-05
Primary Completion
2023-06-29
Completion
2023-06-29
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • France
  • Japan
  • Netherlands
  • Singapore
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03792841 on ClinicalTrials.gov