FPT155 in Patients With Advanced Solid Tumors

NCT ID: NCT04074759

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-18
• Study Completion Date: 2021-08-10

Brief Summary

This study is a Phase 1 open-label, first-in-human, multicenter study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and activity of FPT155 as monotherapy in patients with advanced solid tumors.

Detailed Description

This Phase 1 study is comprised of dose escalation and cohort expansions for FPT155 monotherapy and for FPT155 in combination with pembrolizumab. Monotherapy dose escalation is designed with initial accelerated titration followed by a standard 3+3 dose escalation; combination dose escalation uses a standard 3+3 design. Patients will remain on study treatment until progression of disease, unacceptable toxicity, or other specified reason for discontinuation.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FPT155 monotherapy

The study consists of dose escalation and cohort expansions

Group Type: EXPERIMENTAL

FPT155

Intervention Type: BIOLOGICAL

A soluble CD80 fusion protein

FPT155 in combination with pembrolizumab

The study consists of dose escalation and cohort expansions

Group Type: EXPERIMENTAL

FPT155

Intervention Type: BIOLOGICAL

A soluble CD80 fusion protein

pembrolizumab

Intervention Type: BIOLOGICAL

An anti-PD1 antibody

Interventions

FPT155

A soluble CD80 fusion protein

Intervention Type: BIOLOGICAL

pembrolizumab

An anti-PD1 antibody

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed solid tumors (except primary central nervous system tumors). For patients enrolled for treatment with FPT155+pembrolizumab: histologically confirmed non-small cell lung cancer not eligible for curative therapy.
• Disease that is unresectable, locally advanced, or metastatic and has progressed following all standard treatments or is not appropriate for standard treatments
• All patients must have at least one measurable lesion at baseline according to RECIST v1.1
• Availability of archival tumor tissue and consent to provide archival tumor for retrospective biomarker analysis, or consent to undergo a fresh tumor biopsy during screening
• For patients participating in cohort expansions: consent to undergo a mandatory fresh tumor biopsy during screening and on treatment
• ECOG performance status of 0 or 1
• Prior radiotherapy must be completed at least 2 weeks before first dose of study treatment administration. No radiopharmaceuticals (eg, strontium, samarium) within 8 weeks before first dose of study treatment administration.
• Prior surgery that requires general anesthesia must be completed at least 14 days before first dose of study treatment
• Adequate bone marrow, liver and kidney function

Exclusion Criteria

• Uncontrolled or significant cardiac disease
• Any uncontrolled medical condition or psychiatric disorder including infection, autoimmune disease, bleeding disorder or symptomatic involvement of the central nervous system
• Treatment with any anti-cancer therapy or participation in another investigational drug or biologics trial within 28 days or ≤ 5 half-lives (whichever is shorter)
• Patients who discontinue prior immune-modulating therapies (including regimens containing an immune agonist or a PD-L1/PD-1 antagonist) due to toxicity or have received treatment within 5 half lives or 90 days
• Pregnancy or breastfeeding
• For patients participating in cohort expansion: Prior treatment with a CTLA-4 antagonist, including ipilimumab and tremelimumab

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Five Prime Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia

Scientia Clinical Research

Randwick, New South Wales, Australia

ICON

Auchenflower, Queensland, Australia

Olivia Newton-John Cancer Center

Heidelberg, Victoria, Australia

Cabrini Hospital

Malvern, Victoria, Australia

Linear Clinical Research

Nedlands, Western Australia, Australia

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

St Vincent Hospital of the Catholic University of Korea

Suwon, Gyeonggi-do, South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Countries

Australia; South Korea

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

FPT155-001

Identifier Type: -

Identifier Source: org_study_id