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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04074759
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : April 16, 2020
Sponsor:
Information provided by (Responsible Party):
Five Prime Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Biological: FPT155 Biological: pembrolizumab Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 322 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Two arm trial with multiple cohorts
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Safety and Tolerability Study of FPT155 in Patients With Advanced Solid Tumors
Actual Study Start Date : November 14, 2018
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Monotherapy: Maximum tolerated dose (MTD) of FPT155 [ Time Frame: Approximately 16 months ]
    Determined by the frequency of dose-limiting toxicities during dose-escalation

  2. Monotherapy: Incidence of treatment emergent adverse events [ Time Frame: Through study completion, approximately 30 months ]
    Severity graded per CTCAE version 4.03

  3. FPT155 + pembrolizumab: Maximum tolerated dose (MTD) of FPT155 [ Time Frame: Approximately 12 months ]
    Determined by the frequency of dose-limiting toxicities during dose-escalation

  4. FPT155 + pembrolizumab: Incidence of treatment emergent adverse events [ Time Frame: Through study completion, approximately 30 months ]
    Severity graded per CTCAE version 4.03


Secondary Outcome Measures :
  1. Pharmacokinetic profile FPT155 [ Time Frame: Through study completion, approximately 30 months ]
    Area under serum concentration-time curve of FPT155

  2. Incidence of treatment emergent anti-FPT155 antibody response [ Time Frame: Through study completion, approximately 30 months ]
    Immunogenicity

  3. Pharmacokinetic profile FPT155 [ Time Frame: Through study completion, approximately 30 months ]
    Maximum serum concentration of FPT155

  4. Pharmacokinetic profile FPT155 [ Time Frame: Through study completion, approximately 30 months ]
    Trough serum concentration of FPT155

  5. Pharmacokinetic profile FPT155 [ Time Frame: Through study completion, approximately 30 months ]
    Clearance of FPT155

  6. Pharmacokinetic profile FPT155 [ Time Frame: Through study completion, approximately 30 months ]
    Terminal Half-Life of FPT155

  7. Pharmacokinetic profile FPT155 [ Time Frame: Through study completion, approximately 30 months ]
    Volume of distribution

  8. Objective response rate [ Time Frame: Through study treatment, approximately a median of 6 months ]
    Defined as the proportion of patients with a response of either complete response or partial response as determined by investigator per RECIST v1.1

  9. Cohort Expansions only: Progression-free survival [ Time Frame: Approximately a median of 6 months ]
    Defined as the total duration from enrollment to disease progression or death

  10. Cohort Expansions only: Duration of response [ Time Frame: Approximately a median of 9 months ]
    Time from complete or partial response per RECIST v1.1, until progression of disease or death



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04074759


Contacts
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Contact: Siddhartha Mitra (877)499-2094 FPT155-001@fiveprime.com
Contact: Stefanie Sun (877)499-2094 FPT155-001@fiveprime.com

Locations
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Australia, New South Wales
Chris O'Brien Lifehouse Recruiting
Camperdown, New South Wales, Australia, 2050
St Vincent's Hospital Sydney Recruiting
Darlinghurst, New South Wales, Australia, 2010
Scientia Clinical Research Recruiting
Randwick, New South Wales, Australia, 2031
Australia, Queensland
ICON Recruiting
Auchenflower, Queensland, Australia, 4066
Australia, Victoria
Olivia Newton-John Cancer Center Recruiting
Heidelberg, Victoria, Australia, 3084
Cabrini Hospital Recruiting
Malvern, Victoria, Australia, 3144
Australia, Western Australia
Linear Clinical Research Recruiting
Nedlands, Western Australia, Australia, 6009
Korea, Republic of
National Cancer Center Recruiting
Goyang-Si, Gyeonggi-do, Korea, Republic of, 10408
St Vincent Hospital of the Catholic University of Korea Recruiting
Suwon-Si, Gyeonggi-do, Korea, Republic of, 16247
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 03722
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Sponsors and Collaborators
Five Prime Therapeutics, Inc.
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Responsible Party: Five Prime Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04074759    
Other Study ID Numbers: FPT155-001
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents