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A Study of FT-7051 in Men With MCRPC | Clinical Trials | Clareo Health

TERMINATEDPHASE1

A Study of FT-7051 in Men With MCRPC

A Phase 1 Study of FT-7051 in Men With Metastatic Castration-Resistant Prostate Cancer

NCT04575766•Novo Nordisk A/S

Summary

This is a Phase 1, open-label study that will evaluate the safety and tolerability of FT-7051 and determine the recommended Phase 2 dose (RP2D) as well as pharmacokinetics (PK), preliminary anti-tumor activity, and pharmacodynamics (PD) of FT-7051 in men with metastatic castration-resistant prostate cancer who have progressed despite prior therapy and had been treated with at least one potent anti-androgen therapy. The starting dose, 25 mg once daily (QD), of FT-7051 administered discontinuously (21 days on/7 days off) in 28-day cycles.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Signed informed consent
•Diagnosis of progressive metastatic castration-resistant prostate cancer (mCRPC)
•Previously failed at least one potent anti-androgen therapy
•Castrate levels of serum testosterone
•ECOG performance status 0-2
•Adequate bone marrow function
•Adequate kidney, heart and liver function

Exclusion Criteria

•Prior solid organ transplant
•Prior treatment with small molecules including chemotherapy, antibody, or other experimental anticancer therapeutic within 4 weeks of first dose of study treatment
•Prior radiation therapy within 4 weeks prior to initiation of study treatment (including radiofrequency ablation)
•Prior androgen antagonist therapy (enzalutamide, apalutamide, abiraterone acetate, or darolutamide) within 2 weeks
•Prior radium-223 therapy within 6 weeks
•Symptomatic, untreated or actively progressing central nervous system (CNS) metastasis
•Unstable or severe, uncontrolled medical condition (e.g., unstable cardiac function, unstable pulmonary condition including pneumonitis and/or interstitial lung disease, uncontrolled diabetes, active or uncontrolled infection requiring systemic therapy) or any important medical illness or abnormal laboratory finding that would, in the Investigator's judgement, increase the risk to the patient associated with participation in the study
•Concomitant medications that cause Torsades de Pointes that have not reached steady state before first dose of the study drug
•Concomitant medications that are strong inhibitors or inducers of CYP3A4 or an inhibitor of P-gp
•History of infection with human immunodeficiency virus (HIV)
+1 more criteria

Locations (8)

HonorHealth

Scottsdale, Arizona, United States

University of Colorado Health

Aurora, Colorado, United States

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois, United States

University of Maryland, Greenebaum Cancer Center

Baltimore, Maryland, United States

Washington University School of Medicine

St Louis, Missouri, United States

Icahn School of Medicine at Mt. Sinai

New York, New York, United States

Duke University Health System

Durham, North Carolina, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Key Dates

Start Date

December 30, 2020

Primary Completion Date

November 8, 2022

Completion Date

November 15, 2022

Last Updated

August 9, 2023

Enrollment

ACTUAL participants

Conditions

Metastatic Castration-resistant Prostate Cancer

Interventions

FT-7051

DRUG

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

View study

RECRUITINGPHASE2

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

NCT05489211

Endometrial CancerGastric Cancer+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 9, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of FT-7051 in Men With MCRPC

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC

A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)

SHR-1701 in Combination With Stereotactic Body Radiotherapy in mCRPC

A Study of SYNC-T Therapy SV-102 in Participants With Metastatic Castration-Resistant Prostate Cancer