A Study of FT-7051 in Men With MCRPC

• ClinicalTrials.gov Identifier: NCT04575766
• Recruitment Status: Terminated
• First Posted: October 5, 2020
• Last Update Posted: March 6, 2023
• Sponsor: Forma Therapeutics, Inc.
• Information provided by (Responsible Party): Forma Therapeutics, Inc.

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Metastatic Castration-resistant Prostate Cancer	Drug: FT-7051	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1 Study of FT-7051 in Men With Metastatic Castration-Resistant Prostate Cancer
• Actual Study Start Date: December 30, 2020
• Actual Primary Completion Date: November 8, 2022
• Actual Study Completion Date: November 15, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Dose escalation study of FT-7051	Drug: FT-7051; Dose levels: Dose Level -1 through Dose Level 7, assigned per the protocol using a BOIN design. Additional dose levels may be explored as applicable. Capsules available in strengths of 10mg, 25mg, and 100 mg that are orally administered per the protocol frequency and dose level.

Outcome Measures

Primary Outcome Measures :

1. Incidence of dose limiting toxicities (DLTs) [ Time Frame: Within first 4 weeks of treatment ]
2. Serious adverse events (SAEs) and clinically relevant adverse events (AEs) [ Time Frame: The treatment duration, predicted average 26 weeks ]
3. Incidence of clinical laboratory abnormalities as assessed by CTCAE v5.0 [ Time Frame: The treatment duration, predicted average 26 weeks ]

Secondary Outcome Measures :

1. Prostate-specific antigen (PSA): Percent Change from Baseline [ Time Frame: 12 weeks ]
2. Prostate-specific antigen (PSA): Maximum Decrease from Baseline [ Time Frame: The treatment duration, predicted average 26 weeks ]
3. Prostate-specific antigen (PSA): Time to Progression [ Time Frame: The treatment duration, predicted average 26 weeks ]
4. Time to radiographic progression (rTTP) [ Time Frame: The treatment duration, predicted average 26 weeks ]
5. Overall response rate: radiographic response rate [ Time Frame: The treatment duration, predicted average 26 weeks ]
6. Complete response rate [ Time Frame: The treatment duration, predicted average 26 weeks ]
7. Area under the plasma concentration versus time curve (AUC) [ Time Frame: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment ]
8. Peak Plasma Concentration (Cmax) [ Time Frame: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment ]
9. Time of peak plasma concentration (Tmax) [ Time Frame: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment ]
10. Terminal elimination half-life (T 1/2) [ Time Frame: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment ]
11. Apparent plasma clearance (CL/F) [ Time Frame: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment ]
12. Apparent volume of distribution (Vd/F) [ Time Frame: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment ]
13. Model-based estimate of change from baseline QT interval corrected using Fridericia's correction formula (QTcF) and 90% confidence interval at the estimated Cmax [ Time Frame: Electrocardiogram collected at multiple timepoints during the first 45 days of treatment ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

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)
• Active infection with hepatitis B, or hepatitis C virus

Contacts and Locations

Locations

United States, Arizona

HonorHealth

Scottsdale, Arizona, United States, 85258

United States, Colorado

University of Colorado Health

Aurora, Colorado, United States, 80045

United States, Illinois

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois, United States, 60611

United States, Maryland

University of Maryland, Greenebaum Cancer Center

Baltimore, Maryland, United States, 21201

United States, Missouri

Washington University School of Medicine

Saint Louis, Missouri, United States, 63110

United States, New York

Icahn School of Medicine at Mt. Sinai

New York, New York, United States, 10029

United States, North Carolina

Duke University Health System

Durham, North Carolina, United States, 27710

United States, South Carolina

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States, 29572

Sponsors and Collaborators

Forma Therapeutics, Inc.

Investigators

• Study Director: Emma Barrett, MD; Forma Therapeutics, Inc.

More Information

• Responsible Party: Forma Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT04575766
• Other Study ID Numbers: 7051-ONC-101
• First Posted: October 5, 2020
• Last Update Posted: March 6, 2023
• Last Verified: March 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Forma Therapeutics, Inc.:

Metastatic Castration-resistant Prostate Cancer; Prostate cancer; Urogenital disease; Prostatic disease; Hormone antagonists; Hormones, hormone substitutes; FT-7051

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases