A Study of FT-7051 in Men With MCRPC

Study Overview
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Brief Summary
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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.

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

Conditions
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Metastatic Castration-resistant Prostate Cancer

Intervention / Treatment
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* Drug: FT-7051


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose escalation study of FT-7051<br> | Drug: FT-7051<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of dose limiting toxicities (DLTs) |  | Within first 4 weeks of treatment | 
| Serious adverse events (SAEs) and clinically relevant adverse events (AEs) |  | The treatment duration, predicted average 26 weeks | 
| Incidence of clinical laboratory abnormalities as assessed by CTCAE v5.0 |  | The treatment duration, predicted average 26 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic Castration-resistant Prostate Cancer, Prostate cancer, Urogenital disease, Prostatic disease, Hormone antagonists, Hormones, hormone substitutes, FT-7051