FPT155 in Patients With Advanced Solid Tumors (FPT155-001)

A Phase 1 Safety and Tolerability Study of FPT155 in Patients With Advanced Solid Tumors

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.

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Biological: FPT155; Biological: pembrolizumab

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Chris O'Brien Lifehouse
    • Darlinghurst, New South Wales, Australia, 2010
      • St Vincent's Hospital Sydney
    • Randwick, New South Wales, Australia, 2031
      • Scientia Clinical Research
  • Queensland
    • Auchenflower, Queensland, Australia, 4066
      • ICON
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Olivia Newton-John Cancer Center
    • Malvern, Victoria, Australia, 3144
      • Cabrini Hospital
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Linear Clinical Research
• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Gyeonggi-do
    • Goyang-Si, Gyeonggi-do, Korea, Republic of, 10408
      • National Cancer Center
    • Suwon-Si, Gyeonggi-do, Korea, Republic of, 16247
      • St Vincent Hospital of the Catholic University of Korea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FPT155 monotherapy; The study consists of dose escalation and cohort expansions	Biological: FPT155; A soluble CD80 fusion protein
Experimental: FPT155 in combination with pembrolizumab; The study consists of dose escalation and cohort expansions	Biological: FPT155; A soluble CD80 fusion protein; Biological: pembrolizumab; An anti-PD1 antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monotherapy: Maximum tolerated dose (MTD) of FPT155	Determined by the frequency of dose-limiting toxicities during dose-escalation	Approximately 16 months
Monotherapy: Incidence of treatment emergent adverse events	Severity graded per CTCAE version 4.03	Through study completion, approximately 30 months
FPT155 + pembrolizumab: Maximum tolerated dose (MTD) of FPT155	Determined by the frequency of dose-limiting toxicities during dose-escalation	Approximately 12 months
FPT155 + pembrolizumab: Incidence of treatment emergent adverse events	Severity graded per CTCAE version 4.03	Through study completion, approximately 30 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic profile FPT155	Area under serum concentration-time curve of FPT155	Through study completion, approximately 30 months
Incidence of treatment emergent anti-FPT155 antibody response	Immunogenicity	Through study completion, approximately 30 months
Pharmacokinetic profile FPT155	Maximum serum concentration of FPT155	Through study completion, approximately 30 months
Pharmacokinetic profile FPT155	Trough serum concentration of FPT155	Through study completion, approximately 30 months
Pharmacokinetic profile FPT155	Clearance of FPT155	Through study completion, approximately 30 months
Pharmacokinetic profile FPT155	Terminal Half-Life of FPT155	Through study completion, approximately 30 months
Pharmacokinetic profile FPT155	Volume of distribution	Through study completion, approximately 30 months
Objective response rate	Defined as the proportion of patients with a response of either complete response or partial response as determined by investigator per RECIST v1.1	Through study treatment, approximately a median of 6 months
Cohort Expansions only: Progression-free survival	Defined as the total duration from enrollment to disease progression or death	Approximately a median of 6 months
Cohort Expansions only: Duration of response	Time from complete or partial response per RECIST v1.1, until progression of disease or death	Approximately a median of 9 months

Collaborators and Investigators

• Sponsor: Five Prime Therapeutics, Inc.
• Investigators: Study Director: MD, Amgen

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2018
• Primary Completion (Actual): October 18, 2021
• Study Completion (Actual): October 18, 2021

Study Registration Dates

• First Submitted: August 13, 2019
• First Submitted That Met QC Criteria: August 28, 2019
• First Posted (Actual): August 30, 2019

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Pembrolizumab
• Other Study ID Numbers: FPT155-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No