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

December 4, 2024 updated by: Five Prime Therapeutics, Inc.

A Phase 1a/1b 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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
Time Frame: 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
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)
Time Frame: Cycle 1 (one cycle = 21 days) Day 1 post-dose, up to approximately 21 days
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
Time Frame: Median (min, max) duration of FPT155 exposure was 8.29 [3.0, 27.1] weeks.
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
Time Frame: Median (min, max) duration of FPT155 exposure was 8.29 [3.0, 27.1] weeks.
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
Time Frame: Median (min, max) duration of FPT155 exposure was 8.29 [3.0, 27.1] weeks.
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
Time Frame: Cycle 1 (one cycle = 21 days) Day 1 post-dose, up to approximately 21 days
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Phase 1a Monotherapy: Area Under Serum Concentration-time Profile From Time 0 to Time Tau (The Dosing Interval) (AUC0-tau) of FPT155
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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: Volume of Distribution at Steady State (Vss) of FPT155
Time Frame: 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
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: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response
Time Frame: Cycle 1 (21-day cycles) Day 1
Data presented below includes participants with at least 1 anti-drug antibodies-positive sample relative to baseline after initiation of the treatment.
Cycle 1 (21-day cycles) Day 1
Phase 1b Monotherapy: Objective Response Rate (ORR) Per RECIST v1.1
Time Frame: Up to approximately 30 months
ORR was defined as the total number of participants with confirmed responses of either complete response (CR) (CR: The disappearance of all target lesions, any pathological lymph nodes [whether target or non-target] must have a reduction in short axis to <10 mm) or partial response (PR) (PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters), as determined by the investigator per RECIST v1.1.
Up to approximately 30 months
Phase 1b Monotherapy: Duration of Response (DOR) Per RECIST v1.1
Time Frame: Up to approximately 30 months
DOR was defined as the time from first response (CR [The disappearance of all target lesions, any pathological lymph nodes {whether target or non-target} or PR [At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters] determined by the investigator per RECIST v1.1) that was subsequently confirmed until the onset of progressive disease (DP) (DP: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study [this includes the baseline sum if that is the smallest on study]. In addition to the 20% relative increase, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression) or death from any cause, whichever occurred first.
Up to approximately 30 months
Phase 1b Monotherapy: Progression-free Survival (PFS) Per RECIST v1.1
Time Frame: Up to approximately 30 months
PFS was defined as time from the first dose of study treatment until the first documentation by the investigator of DP (DP: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study [this includes the baseline sum if that is the smallest on study]. In addition to the 20% relative increase, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression) per RECIST v1.1 or death from any cause, whichever occurred first. The median was estimated by using the Kaplan-Meier method and corresponding 2-sided 90% CI using Brookmeyer and Crowley methodology.
Up to approximately 30 months
Phase 1b Monotherapy: Disease Control Rate (DCR) Per RECIST v1.1
Time Frame: Up to approximately 30 months
DCR was defined as the total number of participants with confirmed responses of either CR (CR: The disappearance of all target lesions, any pathological lymph nodes [whether target or non-target] must have a reduction in short axis to <10 mm), PR (PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters), or stable disease (SD) (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. In numerical terms, it means a reduction in tumor size that is less than 30% [which is required for PR] and an increase in size that is less than 20% [which is required for PD]) as determined by the investigator per RECIST v1.1.
Up to approximately 30 months
Phase 1b Monotherapy: AUC0-tau of FPT155
Time Frame: 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
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 1b Monotherapy: Cmax of FPT155
Time Frame: 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
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 1b Monotherapy: Ctrough of FPT155
Time Frame: 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
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 1b Monotherapy: CL of FPT155
Time Frame: 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
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 1b Monotherapy: t1/2 of FPT155
Time Frame: 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
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 1b Monotherapy: Vss of FPT155
Time Frame: 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
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 1b Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response
Time Frame: Cycle 1 (21-day cycles) Day 1
Data presented below includes participants with at least 1 anti-drug antibodies-positive sample relative to baseline after initiation of the treatment.
Cycle 1 (21-day cycles) Day 1
Phase 1a Combination: ORR Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time Frame: Up to approximately 30 months
ORR was defined as the total number of participants with confirmed responses of either CR (CR: The disappearance of all target lesions, any pathological lymph nodes [whether target or non-target] must have a reduction in short axis to <10 mm) or PR (PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters), as determined by the investigator per RECIST v1.1.
Up to approximately 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Five Prime Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: MD, Amgen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 18, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 10, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 10, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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