Advanced Solid TumorsPhase 1FPT155-001NCT04074759

FPT155 in Patients With Advanced Solid Tumors

A Phase 1 study testing FPT155 and pembrolizumab in people with Advanced Solid Tumors, run by Five Prime Therapeutics, Inc. at 12 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Solid Tumors
What is being tested?: FPT155 and pembrolizumab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 12 sitesin 2 countries
Study dates: 18 Oct 2018to 10 Aug 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

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

Who cannot join

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

Trial locations and contacts

12 sites in 2 countries.

Country

City, postcode or hospital

12 sites in 2 countries

Australia7 sites

ICON
Auchenflower, Queensland, 4066
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010
Olivia Newton-John Cancer Center
Heidelberg, Victoria, 3084
Cabrini Hospital
Malvern, Victoria, 3144
Linear Clinical Research
Nedlands, Western Australia, 6009
Scientia Clinical Research
Randwick, New South Wales, 2031

Other trials in Australia

South Korea5 sites

National Cancer Center
Goyang-si, Gyeonggi-do, 10408
Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yonsei University Health System
Seoul, 03722
Samsung Medical Center
Seoul, 06351
St Vincent Hospital of the Catholic University of Korea
Suwon, Gyeonggi-do, 16247

Other trials in South Korea

About this study

Official title: A Phase 1a/1b Study of FPT155 in Patients With Advanced Solid Tumors

Read the 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
Being tested: FPT155, pembrolizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FPT155Biological
A soluble CD80 fusion protein
pembrolizumabBiological
An anti-PD1 antibody

Study groups in NCT04074759
Study group	Role	What they receive
FPT155 monotherapy	Experimental	The study consists of dose escalation and cohort expansions Receives: Biological: FPT155
FPT155 in combination with pembrolizumab	Experimental	The study consists of dose escalation and cohort expansions Receives: Biological: FPT155; Biological: pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Data presented below includes participants with at least 1 anti-drug antibodies-positive sample relative to baseline after initiation of the treatment.
Measured: Cycle 1 (21-day cycles) Day 1
Phase 1b Monotherapy: Objective Response Rate (ORR) Per RECIST v1.1
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.
Measured: Up to approximately 30 months
Phase 1b Monotherapy: Duration of Response (DOR) Per RECIST v1.1
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.
Measured: Up to approximately 30 months
Phase 1b Monotherapy: Progression-free Survival (PFS) Per RECIST v1.1
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.
Measured: Up to approximately 30 months
Phase 1b Monotherapy: Disease Control Rate (DCR) Per RECIST v1.1
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.
Measured: Up to approximately 30 months
Phase 1b Monotherapy: AUC0-tau of FPT155
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Data presented below includes participants with at least 1 anti-drug antibodies-positive sample relative to baseline after initiation of the treatment.
Measured: Cycle 1 (21-day cycles) Day 1
Phase 1a Combination: ORR Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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.
Measured: Up to approximately 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Oct 201810 Aug 2021

First posted30 Aug 2019
Study start18 Oct 2018
Primary completion10 Aug 2021
Study completion10 Aug 2021

Why it stopped: Sponsor decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Model description: Two arm trial with multiple cohorts
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04074759
Sponsor's protocol ID: FPT155-001
Acronym: FPT155-001
Status last verified: Feb 2024
First submitted: 13 Aug 2019
Last updated: 23 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Advanced/Metastatic Solid Tumors, Colorectal Cancer
RecruitingPhase 2
A Study of Navlimetostat (BMS-986504) Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
Solid Tumors
RecruitingPhase 1
Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TGW101 in Participants With Advanced Solid Tumors
Advanced Solid Tumors
RecruitingPhase 1/2
CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
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All Advanced Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1a/1b Study of FPT155 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT04074759
Acronym / sponsor ID: FPT155-001 / FPT155-001
Conditions: Advanced Solid Tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor decision
Enrolment: 80 participants (actual)
Lead sponsor: Five Prime Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 18 Oct 2018 (actual)
Primary completion: 10 Aug 2021 (actual)
Study completion: 10 Aug 2021 (actual)
First posted: 30 Aug 2019 (actual)
Results: Posted 23 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2
Model description: Two arm trial with multiple cohorts

Arm	Type	Receives
FPT155 monotherapy	Experimental	Biological: FPT155The study consists of dose escalation and cohort expansions
FPT155 in combination with pembrolizumab	Experimental	Biological: FPT155, Biological: pembrolizumabThe study consists of dose escalation and cohort expansions

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FPT155A soluble CD80 fusion protein	Biological	FPT155 in combination with pembrolizumab, FPT155 monotherapy
pembrolizumabAn anti-PD1 antibody	Biological	FPT155 in combination with pembrolizumab

Primary outcome

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.
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.
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.
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.
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.
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.

19 secondary outcomes

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
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
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
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
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
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
Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response
Time frame: 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
Phase 1b Monotherapy: Duration of Response (DOR) Per RECIST v1.1
Time frame: Up to approximately 30 months
Phase 1b Monotherapy: Progression-free Survival (PFS) Per RECIST v1.1
Time frame: Up to approximately 30 months
Phase 1b Monotherapy: Disease Control Rate (DCR) Per RECIST v1.1
Time frame: 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
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
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
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
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
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
Phase 1b Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response
Time frame: 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

Results and safety

Results posted to the registry on 23 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1a Monotherapy: FPT155 Dose A	1	0
Phase 1a Monotherapy: FPT155 Dose B	1	0
Phase 1a Monotherapy: FPT155 Dose C	2	0
Phase 1a Monotherapy: FPT155 Dose D	1	0
Phase 1a Monotherapy: FPT155 Dose E	4	0
Phase 1a Monotherapy: FPT155 Dose F	3	0
Phase 1a Monotherapy: FPT155 Dose G	3	0
Phase 1a Monotherapy: FPT155 Dose H	3	0
Phase 1a Monotherapy: FPT155 Dose I	7	2
Phase 1a Monotherapy: FPT155 Dose J	10	2
Phase 1a Monotherapy: FPT155 Dose K	20	0
Phase 1a Monotherapy: FPT155 Dose L	6	1
Phase 1b Monotherapy: 1bM1 FPT155 Dose K	1	0
Phase 1b Monotherapy: 1bM2 FPT155 Dose K	5	0
Phase 1b Monotherapy: 1bM3 FPT155 Dose K	3	0
Phase 1b Monotherapy: 1bM4 FPT155 Dose K	1	0
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg	3	0
Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg	3	0
Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg	3	0

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Phase 1a Monotherapy: FPT155 Dose A n = 1	Phase 1a Monotherapy: FPT155 Dose B n = 1	Phase 1a Monotherapy: FPT155 Dose C n = 2	Phase 1a Monotherapy: FPT155 Dose D n = 1	Phase 1a Monotherapy: FPT155 Dose E n = 4	Phase 1a Monotherapy: FPT155 Dose F n = 3	Phase 1a Monotherapy: FPT155 Dose G n = 3	Phase 1a Monotherapy: FPT155 Dose H n = 3	Phase 1a Monotherapy: FPT155 Dose I n = 7	Phase 1a Monotherapy: FPT155 Dose J n = 10	Phase 1a Monotherapy: FPT155 Dose K n = 20	Phase 1a Monotherapy: FPT155 Dose L n = 6	Phase 1b Monotherapy: 1bM1 FPT155 Dose K n = 1	Phase 1b Monotherapy: 1bM2 FPT155 Dose K n = 5	Phase 1b Monotherapy: 1bM3 FPT155 Dose K n = 3	Phase 1b Monotherapy: 1bM4 FPT155 Dose K n = 1	Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg n = 3	Phase 1a Combination: FPT155 (Dose I) + Pembrolizumab 200 mg n = 3	Phase 1a Combination: FPT155 (Dose J) + Pembrolizumab 200 mg n = 3
All TEAEs	1	1	2	1	3	2	3	3	6	10	20	6	1	5	3	1	3	3	2
TEAEs Grade 3 or Higher	1	0	1	0	1	1	3	1	1	2	11	2	1	4	2	0	2	3	1
TEAEs Related to FPT155	0	0	1

Population analysed: Safety population: All participants who received any portion of a least one dose of FPT155.

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Phase 1a Monotherapy: FPT155 Dose A n = 1	Phase 1a Monotherapy: FPT155 Dose B n = 1	Phase 1a Monotherapy: FPT155 Dose C n = 2	Phase 1a Monotherapy: FPT155 Dose D n = 1	Phase 1a Monotherapy: FPT155 Dose E n = 3	Phase 1a Monotherapy: FPT155 Dose F n = 3	Phase 1a Monotherapy: FPT155 Dose G n = 3	Phase 1a Monotherapy: FPT155 Dose H n = 3	Phase 1a Monotherapy: FPT155 Dose I n = 3	Phase 1a Monotherapy: FPT155 Dose J n = 3	Phase 1a Monotherapy: FPT155 Dose K n = 3	Phase 1a Monotherapy: FPT155 Dose L n = 6
All DLTs	0	0	0	0	0	0	0	0	0	0	0	2
Cytokine release syndrome	0	0	0	0	0	0	0	0	0	0	0	1
Infusion related reaction	0	0	0	0	0	0	0	0	0	0	0	1

Population analysed: DLT-evaluable population: All participants enrolled into Phase 1a dose escalation portion of the study who received at least 1 dose of all assigned study drug(s) and remain on study for the 21-day DLT evaluation period, or who experienced a DLT before clearing the 21-day DLT evaluation interval. Study used a 3 + 3 design in the Phase 1a Monotherapy cohorts, from cohort "Phase 1a Monotherapy: FPT155 Dose E".

Primary outcome: 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.. Count of participants. Unit: Participants

Measure	Phase 1b Monotherapy: 1bM1 FPT155 Dose K n = 1	Phase 1b Monotherapy: 1bM2 FPT155 Dose K n = 5	Phase 1b Monotherapy: 1bM3 FPT155 Dose K n = 3	Phase 1b Monotherapy: 1bM4 FPT155 Dose K n = 1
Value	0	0	2	0

Population analysed: Safety population: All participants who received any portion of a least one dose of FPT155.

Primary outcome: 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.. Count of participants. Unit: Participants

Measure	Phase 1b Monotherapy: 1bM1 FPT155 Dose K n = 1	Phase 1b Monotherapy: 1bM2 FPT155 Dose K n = 5	Phase 1b Monotherapy: 1bM3 FPT155 Dose K n = 3	Phase 1b Monotherapy: 1bM4 FPT155 Dose K n = 1
Value	0	1	0	0

Population analysed: Safety population: All participants who received any portion of a least one dose of FPT155.

19 secondary outcomes are reported in the full results.

Adverse events

Group	Serious adverse events	Other adverse events	Deaths
Phase 1a Monotherapy: FPT155 Dose A	1 of 1 (100%)	0 of 1 (0%)	1 of 1
Phase 1a Monotherapy: FPT155 Dose B	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Phase 1a Monotherapy: FPT155 Dose C	1 of 2 (50%)	2 of 2 (100%)	1 of 2
Phase 1a Monotherapy: FPT155 Dose D	0 of 1 (0%)	1 of 1 (100%)	1 of 1
Phase 1a Monotherapy: FPT155 Dose E	1 of 4 (25%)	3 of 4 (75%)	2 of 4
Phase 1a Monotherapy: FPT155 Dose F	1 of 3 (33.3%)	2 of 3 (66.7%)	0 of 3
Phase 1a Monotherapy: FPT155 Dose G	3 of 3 (100%)	3 of 3 (100%)	1 of 3
Phase 1a Monotherapy: FPT155 Dose H	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Phase 1a Monotherapy: FPT155 Dose I	2 of 7 (28.6%)	6 of 7 (85.7%)	3 of 7
Phase 1a Monotherapy: FPT155 Dose J	3 of 10 (30%)	10 of 10 (100%)	2 of 10
Phase 1a Monotherapy: FPT155 Dose K	10 of 20 (50%)	18 of 20 (90%)	4 of 20
Phase 1a Monotherapy: FPT155 Dose L	2 of 6 (33.3%)	5 of 6 (83.3%)	1 of 6
Phase 1b Monotherapy: 1bM1 FPT155 Dose K	1 of 1 (100%)	1 of 1 (100%)	0 of 1
Phase 1b Monotherapy: 1bM2 FPT155 Dose K	0 of 5 (0%)	5 of 5 (100%)	2 of 5
Phase 1b Monotherapy: 1bM3 FPT155 Dose K	2 of 3 (66.7%)	3 of 3 (100%)	1 of 3
Phase 1b Monotherapy: 1bM4 FPT155 Dose K	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Phase 1a Combination: FPT155 (Dose H) + Pembrolizumab 200 mg

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

12 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FPT155 and pembrolizumab in people with Advanced Solid Tumors, run by Five Prime Therapeutics, Inc. at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Australia, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04074759.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.