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.
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
| Drug | Synonyms | Arms |
|---|
| FPA144 | anti-hFGFR2b receptor antibody | Part 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
| Name | Type | Description | Interventions |
|---|
| Part 1A: FPA144 Dose Escalation Solid Tumors | Experimental | IV infusion; safety data will be reviewed prior to dose escalation decision. Dose escalation will complete when recommended dose (RD) is determined. | |
| Part 1B: FPA144 Dose Escalation Gastric Cancer | Experimental | IV infusion; safety data will be reviewed prior to dose escalation decision. Dose escalation will complete when recommended dose (RD) is determined. | |
| Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors | Experimental | IV 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. | |
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
