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:

Completed

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

  • Advanced Solid Tumors
  • Gastric Cancer
  • Transitional Cell Carcinoma of the Bladder

Interventions

DrugSynonymsArms
FPA144BemarituzumabPart 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 TumorsExperimentalDose escalation of FPA144 (0.3 mg/kg to 15 mg/kg)
  • FPA144
Part 1B: FPA144 Dose Escalation Gastric CancerExperimentalDose escalation of FPA144 (3-10 mg/kg) in patients with gastric cancer
  • FPA144
Part 2: FPA144 Dose Expansion Gastric or Other Solid TumorsExperimentalEvaluation of objective responses in patients with tumors with various levels of FGFR2b overexpression
  • FPA144

Eligibility Criteria

        Inclusion Criteria:

          -  Life expectancy of at least 3 months

          -  ECOG performance status of 0 to 1

             • In sexually-active patients, willingness to use 2 effective methods of contraception

          -  Adequate hematological and organ function, confirmed by lab values

          -  Tumor tissue must be available for prospective determination of FGFR2b overexpression

               -  Locally recurrent or metastatic disease that has progressed on or following
                  standard treatment, or is not a candidate for standard treatment

               -  Histologically or cytologically confirmed transitional cell carcinoma of the
                  genitourinary tract

               -  Measurable disease as defined by RECIST version 1.1

        Exclusion Criteria:

          -  Untreated or symptomatic central nervous system (CNS) metastases

          -  Impaired cardiac function or clinically significant cardiac disease

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

          -  Ongoing acute adverse effects from prior anticancer or investigational therapy > NCI
             CTCAE Grade 1

          -  Retinal disease or a history of retinal disease or detachment

          -  Corneal defects, corneal ulcerations, keratitis, keratoconus, history of corneal
             transplant, or other known abnormalities of the cornea

          -  Major surgical procedures are not allowed ≤28 days prior to FPA144 administration

          -  Females who are pregnant or breastfeeding; women of childbearing potential must not be
             considering getting pregnant during the study

             - Presence of any serious or unstable concomitant systemic disorder incompatible with
             the clinical study

          -  Known allergy or hypersensitivity to components of the FPA144 formulation including
             polysorbate

          -  History of prior malignancy except:

          -  a) Curatively treated non-melanoma skin cancer or

          -  b) Solid tumor treated curatively more than 5 years previously without evidence of
             recurrence or

          -  c) History of other malignancy that in the Investigator's opinion would not affect the
             determination of study treatment effect

          -  Prior treatment with any selective inhibitor (e.g., AZD4547, BGJ398, JNJ-42756493,
             BAY1179470) of the FGF-FGFR pathway
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only).
Time Frame:4 weeks on average
Safety Issue:
Description:Number of participants with grade 3 and grade 4 adverse events (AE) and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs)

Secondary Outcome Measures

Measure:Pharmacokinetic (PK) Profile of FPA144: Maximum Serum Concentration
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. • Summary of area under serum concentration-time curve, maximum serum concentration,
Measure:Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time Frame:16 weeks on average
Safety Issue:
Description:Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measure:Duration of Response Per RECIST 1.1 (Part 2 Only)
Time Frame:16 weeks on average
Safety Issue:
Description:Duration of complete or partial response with 95% confidence intervals in gastric cancer population.
Measure:Pharmacokinetic (PK) Profile of FPA144: Area Under Serum Concentration-time Curve
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. • Summary of area under serum concentration-time curve, maximum serum concentration,

Details

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

Trial Keywords

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

Last Updated

May 3, 2021