A Study of FT-7051 in Men With MCRPC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-30

Study Completion Date

2022-11-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Phase I/II Open-label Study of MCS110 in Patients With Prostate Cancer and Bone Metastases

NCT00757757

Prostate Cancer Bone Metastases

TERMINATED PHASE1/PHASE2

Study of TAS3681 in Metastatic Castration Resistant Prostate Cancer

NCT02566772

Metastatic Castration Resistant Prostate Cancer

COMPLETED PHASE1

[Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application_2

NCT05579184

Metastatic Castration-resistant Prostate Cancer, mCRPC

ACTIVE_NOT_RECRUITING PHASE2

A Safety and Feasibility Study of Mitotane in Prostate Cancer

NCT02057237

Prostate Cancer

COMPLETED PHASE1

A Phase I/II Study of TRC105 in Metastatic Castrate Resistant Prostate Cancer (CRPC)

NCT01090765

Prostate Cancer Metastatic Castrate Resistant Prostate Cancer

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metastatic Castration-resistant Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dose escalation study of FT-7051

Group Type EXPERIMENTAL

FT-7051

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No