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FOR46 in Combination With Enzalutamide in Patients With Metastatic Castration Resistant Prostate Cancer

NCT05011188 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-08-27

No results posted yet for this study

Summary

This is a Phase 1b/2 study evaluating FOR46 in combination with enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) after prior progression on abiraterone. FOR46 is designed to target and bind to CD46, a transmembrane cellular protein expressed at moderate or high levels in numerous cancer types. The investigators hypothesize that the combination of FOR46 plus enzalutamide will achieve a clinically significant composite response rate with sufficient durability of response in mCRPC patients.

Conditions

Interventions

BIOLOGICAL

FOR46

Given intravenously (IV)

BIOLOGICAL

Enzalutamide

Given orally (PO)

DRUG

Pegfilgrastim

Given subcutaneously (subQ)

PROCEDURE

Blood Samples

Blood samples will be taken for correlative studies

Sponsors & Collaborators

  • Fortis Therapeutics, Inc.

    collaborator INDUSTRY

  • FibroGen

    collaborator INDUSTRY

  • Rahul Aggarwal

    lead OTHER

Principal Investigators

  • Rahul Aggarwal, MD · University of San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-19
Primary Completion
2027-07-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT05011188 on ClinicalTrials.gov