For Healthcare Professionals

A Study of FT-7051 in Men With MCRPC

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

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

EXCLUSION CRITERIA

  1. Prior solid organ transplant
  2. Prior treatment with small molecules including chemotherapy, antibody, or other experimental anticancer therapeutic within 4 weeks of first dose of study treatment
  3. Prior radiation therapy within 4 weeks prior to initiation of study treatment (including radiofrequency ablation)
  4. Prior androgen antagonist therapy (enzalutamide, apalutamide, abiraterone acetate, or darolutamide) within 2 weeks
  5. Prior radium-223 therapy within 6 weeks
  6. Symptomatic, untreated or actively progressing central nervous system (CNS) metastasis
  7. 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
  8. Concomitant medications that cause Torsades de Pointes that have not reached steady state before first dose of the study drug
  9. Concomitant medications that are strong inhibitors or inducers of CYP3A4 or an inhibitor of P-gp
  10. History of infection with human immunodeficiency virus (HIV)
  11. Active infection with hepatitis B, or hepatitis C virus
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 617-679-1970Email iconEmail Study Center

Study’s details


Contition

Metastatic Castration-resistant Prostate Cancer

Age (in years)

18 - 200

Phase

Phase 1

Participants needed

45

Est. Completion Date

Mar 2023

Treatment type

Interventional


Sponsor

Forma Therapeutics, Inc.

ClinicalTrials.gov identifier

NCT04575766

Study number

7051-ONC-101

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