FPT155 in Patients With Advanced Solid Tumors

NCT04074759 | Terminated Phase 1 Results

• 1 other identifier: FPT155-001
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 12

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (6)

• Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)

  TEAE was defined as an adverse event (AE) that was not present prior to the start date of study drug or was worsened during treatment and 100 days after last dose of treatment. An AE that was present at treatment initiation but resolved and then reappeared and the event severity increase while the participant was on treatment is also a TEAE. A severe AE (SAE) is defined as any untoward medical occurrence that at any dose: Is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, and is a congenital anomaly/birth defect. AEs were graded 1 (mild)-5 (fatal AE) according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.03.

  Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination

• Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)

  DLTs ware defined as any of the events that occurred during the first 28 days of treatment and were assessed by the Clinical Research Coordinator (CRC) as related to FPT155.

  Cycle 1 (one cycle = 21 days) Day 1 post-dose, up to approximately 21 days

• Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Discontinued Due to AEs

  Represents the number of participants who had discontinuation of FPT155 dosing due to AEs.

  Median (min, max) duration of FPT155 exposure was 8.29 [3.0, 27.1] weeks.

• Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Modified Due to AEs

  Represents the number of participants who had a modification in the dosing schedules of FPT155 due to AEs.

  Median (min, max) duration of FPT155 exposure was 8.29 [3.0, 27.1] weeks.

• Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Interrupted Due to AEs

  Represents the number of participants who had an interruption in the dosing schedules of FPT155 due to AEs.

  Median (min, max) duration of FPT155 exposure was 8.29 [3.0, 27.1] weeks.

• Phase 1a Combination: Number of Participants Who Experienced DLTs

  DLTs ware defined as any of the events that occur during the first 28 days of treatment and are assessed by the CRC as related to FPT155.

  Cycle 1 (one cycle = 21 days) Day 1 post-dose, up to approximately 21 days

Secondary Outcomes (19)

• Phase 1a Monotherapy: Area Under Serum Concentration-time Profile From Time 0 to Time Tau (The Dosing Interval) (AUC0-tau) of FPT155

  Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15

• Phase 1a Monotherapy: Maximum Observed Serum Concentration (Cmax) of FPT155

  Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15

• Phase 1a Monotherapy: Trough Observed Serum Concentration at the End of Each Dose Interval (Ctrough) of FPT155

  Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15

• Phase 1a Monotherapy: Clearance (CL) of FPT155

  Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15

• Phase 1a Monotherapy: Terminal Half-life (t1/2) of FPT155

  Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15

Study Arms (2)

FPT155 monotherapy

EXPERIMENTAL

The study consists of dose escalation and cohort expansions

Biological: FPT155

FPT155 in combination with pembrolizumab

EXPERIMENTAL

The study consists of dose escalation and cohort expansions

Biological: FPT155; Biological: pembrolizumab

Interventions

FPT155 BIOLOGICAL

A soluble CD80 fusion protein

FPT155 in combination with pembrolizumab; FPT155 monotherapy

pembrolizumab BIOLOGICAL

An anti-PD1 antibody

FPT155 in combination with pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Five Prime Therapeutics, Inc.: lead

Study Sites (12)

Chris O'Brien Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia

Location

Scientia Clinical Research

Randwick, New South Wales, 2031, Australia

Location

ICON

Auchenflower, Queensland, 4066, Australia

Location

Olivia Newton-John Cancer Center

Heidelberg, Victoria, 3084, Australia

Location

Cabrini Hospital

Malvern, Victoria, 3144, Australia

Location

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

Location

National Cancer Center

Goyang-si, Gyeonggi-do, 10408, South Korea

Location

St Vincent Hospital of the Catholic University of Korea

Suwon, Gyeonggi-do, 16247, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Interventions

pembrolizumab

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two arm trial with multiple cohorts

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 30, 2019
• Study Start: October 18, 2018
• Primary Completion: August 10, 2021
• Study Completion: August 10, 2021
• Last Updated: January 23, 2025
• Results First Posted: January 23, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (7); KR (5)