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
- Advanced Solid Tumors
- Gastric Cancer
- Transitional Cell Carcinoma of the Bladder
Interventions
Drug | Synonyms | Arms |
---|
FPA144 | Bemarituzumab | 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 | Dose escalation of FPA144 (0.3 mg/kg to 15 mg/kg) | |
Part 1B: FPA144 Dose Escalation Gastric Cancer | Experimental | Dose escalation of FPA144 (3-10 mg/kg) in patients with gastric cancer | |
Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors | Experimental | Evaluation of objective responses in patients with tumors with various levels of FGFR2b overexpression | |
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