Clinical Trials /

Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors

NCT02318329

Description:

This is a three-part, open-label, safety, tolerability, and PK study of FPA144. Patients will be enrolled in Part 1 (A or B, dose escalation) or Part 2 (dose expansion) of the study, but not both.

Related Conditions:
  • Gastric Carcinoma
  • Lymphoma
  • Malignant Solid Tumor
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors
  • Official Title: A Phase 1 Open-Label, Dose-Finding Study Evaluating Safety and Pharmacokinetics of FPA144 in Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: FPA144-001
  • NCT ID: NCT02318329

Conditions

  • Solid Tumors
  • Gastric Cancer

Interventions

DrugSynonymsArms
FPA144anti-hFGFR2b receptor antibodyPart 1A: FPA144 Dose Escalation Solid Tumors

Purpose

This is a three-part, open-label, safety, tolerability, and PK study of FPA144. Patients will be enrolled in Part 1 (A or B, dose escalation) or Part 2 (dose expansion) of the study, but not both.

Detailed Description

      Part 1A is a dose-escalation study in patients with any locally advanced or metastatic solid
      tumor or lymphoma for which standard therapies have been exhausted. Part 1B will further
      assess safety and evaluate PK of FPA144 in gastric cancer patients.

      Part 2 patients will be enrolled and treated in order to further characterize safety and
      preliminary efficacy in a selected cancer patient population with the greatest potential for
      clinical benefit from FPA144 treatment.
    

Trial Arms

NameTypeDescriptionInterventions
Part 1A: FPA144 Dose Escalation Solid TumorsExperimentalIV infusion; safety data will be reviewed prior to dose escalation decision. Dose escalation will complete when recommended dose (RD) is determined.
  • FPA144
Part 1B: FPA144 Dose Escalation Gastric CancerExperimentalIV infusion; safety data will be reviewed prior to dose escalation decision. Dose escalation will complete when recommended dose (RD) is determined.
  • FPA144
Part 2: FPA144 Dose Expansion Gastric or Other Solid TumorsExperimentalIV infusion; once MTD and/or RD has been determined in Part 1, five expansion cohorts of approximately 130-150 patients with gastric or other locally advanced recurrent or metastatic solid tumors will be enrolled.
  • FPA144

Eligibility Criteria

        Inclusion Criteria:

          -  Life expectancy of at least 3 months

          -  ECOG performance status of 0 to 1

          -  Adequate hematological and organ function, confirmed by lab values

          -  Tumor tissue for determination of FGFR2b overexpression and FGFR2 amplification
             (optional for Part 1A patients)

        Exclusion Criteria:

          -  QTc segment >470 msec

          -  Treatment with any anticancer therapy or investigational drugs </=14 days (</=28 days
             for patients in Korea) prior to first dose of FPA144

          -  Presence of any condition that may increase the risk associated with study
             participation or interfere with interpretation of study results
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of Grade 3 and Grade 4 adverse events (AEs) and clinical laboratory abnormalities defined as dose-limiting toxicities (Part 1 only).
Time Frame:4 weeks on average
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Pharmacokinetic profile of FPA144 (area under serum concentration-time curve, maximum serum concentration, minimum serum concentration, clearance, and volume of distribution at steady-state ):
Time Frame:16 weeks on average
Safety Issue:
Description:Sampling following the first dose in Part 1, pre and post-dose at selected cycles, and at the end of treatment for both Part 1 and Part 2.
Measure:Objective response rate (ORR) per RECIST 1.1 (Part 2 only)
Time Frame:16 weeks on average
Safety Issue:
Description:
Measure:Duration of response per RECIST 1.1 (Part 2 only)
Time Frame:16 weeks on average
Safety Issue:
Description:
Measure:Pharmacodynamic profile of FPA144 through an analysis of the immune cell infiltrate in pre-treatment and on-treatment tumor biopsies by tumor type (Part 2 only)
Time Frame:16 weeks on average
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Five Prime Therapeutics, Inc.

Trial Keywords

  • FGFR2b, FGFR2, FGFR, bladder neoplasms, esophageal cancer

Last Updated

January 24, 2017