A Study of FT-7051 in Men With MCRPC

Phase 1

Terminated

• Conditions: Metastatic Castration-resistant Prostate Cancer
• Interventions: Drug: FT-7051

• Registration Number: NCT04575766
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-24
• Study First Submitted QC: 2020-10-01
• Study First Posted: 2020-10-05
• Study Start: 2020-12-30
• Primary Completion: 2022-11-08
• Study Completion: 2022-11-15
• Status Verified: 2023-03
• Last Update Submitted: 2023-08-08
• Last Update Posted: 2023-08-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose escalation study of FT-7051	FT-7051	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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
Prostate-specific antigen (PSA): Percent Change from Baseline	12 weeks
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

Trial Locations

Locations (8)

University of Maryland, Greenebaum Cancer Center; 🇺🇸 Baltimore, Maryland, United States

HonorHealth; 🇺🇸 Scottsdale, Arizona, United States

University of Colorado Health; 🇺🇸 Aurora, Colorado, 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

Robert H. Lurie Comprehensive Cancer Center of Northwestern University; 🇺🇸 Chicago, Illinois, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States