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FPA150 in Patients With Advanced Solid Tumors (FPA150-001)

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ClinicalTrials.gov Identifier: NCT03514121
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Five Prime Therapeutics, Inc.

Brief Summary:
This is a multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of FPA150, an anti-B7H4 antibody in patients with advanced solid tumors. The Phase 1a, open-label, cohort will identify a recommended dose of FPA150 to use for Phase 1b.

Condition or disease Intervention/treatment Phase
Breast Cancer Ovarian Cancer Endometrial Cancer Urothelial Cancer Advanced Solid Tumors Biological: FPA150 Early Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 268 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm trial with multiple cohorts
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1a/1b Study of FPA150, an Anti-B7-H4 Antibody, in Patients With Advanced Solid Tumors
Actual Study Start Date : March 27, 2018
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phase 1a dose escalation
The study consists of Phase 1a dose escalation, Phase 1a dose exploration and Phase 1b dose expansion
Biological: FPA150
A monoclonal antibody against B7-H4




Primary Outcome Measures :
  1. For Phase 1a, to determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of FPA150 [ Time Frame: Through study completion, an average of 24 weeks ]
    Tolerability

  2. For Phase 1a, number of participants with adverse events as assessed by the latest version of CTCAE [ Time Frame: Through study completion, an average of 24 weeks ]
    Safety

  3. For Phase 1b, number of participants with adverse events as assessed by the latest version of CTCAE at the maximum tolerated dose (MTD) and/or recommended dose (RD) of FPA150 [ Time Frame: Through study completion, average 24 weeks ]
    Safety


Secondary Outcome Measures :
  1. Area under serum concentration-time curve of FPA150 in day*µg/mL [ Time Frame: Through study completion, an average of 24 weeks ]
    Pharmacokinetic profile FPA150

  2. Maximum serum concentration of FPA150 in µg/mL [ Time Frame: Through study completion, an average of 24 weeks ]
    Pharmacokinetic Profile FPA150

  3. Trough serum concentration of FPA150 in µg/mL [ Time Frame: Through study completion, an average of 24 weeks ]
    Pharmacokinetic Profile FPA150

  4. Clearance of FPA150 in mL/day/kg [ Time Frame: Through study completion, an average of 24 weeks ]
    Pharmacokinetic Profile FPA150

  5. Terminal Half-Life of FPA150 in day [ Time Frame: Through study completion, an average of 24 weeks ]
    Pharmacokinetic Profile FPA150

  6. Volume of distribution (mL/kg) of FPA150 [ Time Frame: Through study completion, an average of 24 weeks ]
    Pharmacokinetic Profile FPA150

  7. Incidence of treatment emergent anti-FPA150 antibody response (levels in serum) [ Time Frame: Through study completion, an average of 24 weeks ]
    Immunogenicity FPA150

  8. Pharmacodynamic profile of FPA150 [ Time Frame: Through study completion, an average of 24 weeks ]
    Biomarker analysis of the fibroblast growth factor receptor (FGFR) pathway in blood


Other Outcome Measures:
  1. For Phase 1b, to evaluate the overall response rate (ORR) defined as the total number of patients with complete response (CR) or partial response (PR) per RECIST v1.1 divided by the total number of patients who are evaluable for a response [ Time Frame: Through study completion, an average of 24 weeks ]
    Efficacy



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed solid tumors except primary central nervous system (CNS) tumors.
  • Disease that is unresectable, locally advanced, or metastatic.
  • Patients must have had progressive disease during or after, or refused, appropriate standard therapy for their tumor type.
  • All patients must have at least one measurable lesion at baseline according to RECIST v1.1; tumor sites situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, are not considered measurable unless there has been demonstrated progression in the lesion.
  • Adequate washout for prior anti-cancer therapy (ie, ≥ 5 half-lives or 4 weeks since the last dose, whichever is shorter).
  • Availability of archival tumor tissue and consent to providing archival tumor for retrospective biomarker analysis, or willingness to undergo a fresh tumor biopsy during screening (a biopsy is required for patients in the Phase 1a Dose Exploration portion).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Prior radiotherapy must be completed at least 2 weeks before the first dose of study drug.
  • Prior radiopharmaceuticals (eg strontium, samarium) must be completed at least 8 weeks before the first dose of study drug.
  • Screening laboratory values must meet the following criteria:

    • Neutrophils ≥ 1200 cells/ µL
    • Platelets ≥ 75 × 103/ µL
    • Hemoglobin (Hb) ≥ 9.0 g/dL
    • Serum creatinine < 1.5× ULN or creatinine clearance (CrCl) of ≥ 40 mL/ minute
    • AST and ALT < 3× ULN
    • Bilirubin < 1.5× ULN (except patients with Gilbert's syndrome, who must have total bilirubin < 3 mg/dL)

Exclusion Criteria:

  • Immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids (doses > 10 mg/day prednisone or equivalent daily) must be discontinued at least 2 weeks before the first dose of study drug. Short courses of high dose steroids or continuous low dose (prednisone < 10 mg/day ) are allowed.
  • Decreased cardiac function with New York Heart Association (NYHA) > Class 2 at screening.
  • Uncontrolled or significant heart disorder such as unstable angina.
  • QT interval corrected for heart rate (QTc) per institutional guidelines > 450 msec for males or > 470 msec for females at screening.
  • Current unresolved infection or history of chronic, active, clinically significant infection (viral, bacterial, fungal, or other) which, in the opinion of the Investigator, would preclude the patient from exposure to a biologic agent or may pose a risk to patient safety.
  • Any uncontrolled medical condition or psychiatric disorder which, in the opinion of the Investigator, would pose a risk to patient safety or interfere with study participation or interpretation of individual patient results.
  • Active, known, or suspected autoimmune disease. Patients with Type I diabetes mellitus, hypothyroidism requiring only hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger, are permitted to enroll.
  • Known history of testing positive for human immunodeficiency virus (HIV) 1 or 2 or known acquired immunodeficiency syndrome (AIDS).
  • Positive test for hepatitis B virus surface antigen (HBsAg) or detectable hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection.
  • Ongoing adverse effects from prior treatment > Grade 1 (with the exception of Grade 2 alopecia or peripheral neuropathy) based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
  • Symptomatic interstitial lung disease or inflammatory pneumonitis.
  • Untreated or active CNS or leptomeningeal metastases. Patients are eligible if metastases have been treated and patients are neurologically returned to baseline or neurologically stable (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks before the first dose of study drug.
  • Evidence of coagulopathy or bleeding diathesis. Patients receiving stable therapeutic doses of anti-coagulants will be permitted.
  • Transfusion of blood or platelets completed within 72 hours before the first dose of study drug.

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): NCT03514121


Contacts
Contact: Sandeep Inamdar (866) 588-3796 FPA150-001@fiveprime.com
Contact: Stefanie Sun (866) 588-3796 FPA150-001@fiveprime.com

Locations
United States, Arizona
Honor Health Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Jasgit Sachdev, MD         
United States, California
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Zev A Wainberg, MD         
Sarcoma Oncology Research Center Recruiting
Santa Monica, California, United States, 90403
Contact: Sant P Chawla, MD         
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06520
Contact: Patricia LoRusso, DO         
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Amy M. Weise, DO         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Todd Bauer, MD         
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Shubham Pant, MD         
South Texas Accelerated Research Therapeutics Recruiting
San Antonio, Texas, United States, 78229
Contact: Amita Patnaik, MD         
Sponsors and Collaborators
Five Prime Therapeutics, Inc.

Responsible Party: Five Prime Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03514121     History of Changes
Other Study ID Numbers: FPA150-001
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female