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

Primary Purpose

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

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
FPA144
Sponsored by
Five Prime Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Solid Tumors focused on measuring FGFR2b, FGFR2, FGFR, bladder neoplasms, esophageal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope Comprehensive Cancer Center
  • Ronald Reagan UCLA Medical Center
  • UCSF Helen Diller Family Comprehensive Cancer Center, Mission Bay
  • Innovative Cancer Research Institute
  • The University of Chicago Medical Center
  • Dana-Farber Cancer Institute
  • Karmanos Cancer Institute
  • Weill Cornell Medical Center
  • University of Pennsylvania
  • Sarah Cannon Research Institute, LLC
  • Vanderbilt University Medical Center
  • The University of Texas M.D. Anderson Cancer Center
  • South Texas Accelerated Research Therapeutics, LLC
  • Chonbuk National University Hospital
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University
  • Samsung Medical Center
  • Gangnam Severance Hospital
  • Korea University Anam Hospital
  • Seoul St. Mary's Hospital
  • SMG-SNU Boramae Medical Center
  • China Medical University Hospital
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Part 1A: FPA144 Dose Escalation Solid Tumors

Part 1B: FPA144 Dose Escalation Gastric Cancer

Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors

Arm Description

Dose escalation of FPA144 (0.3 mg/kg to 15 mg/kg)

Dose escalation of FPA144 (3-10 mg/kg) in patients with gastric cancer

Evaluation of objective responses in patients with tumors with various levels of FGFR2b overexpression

Outcomes

Primary Outcome Measures

Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only).
Number of participants with grade 3 and grade 4 adverse events (AE) and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs)
Number of Participants With AEs and Clinical Laboratory Abnormalities (Parts 1B and 2 Only)
Number of Participants with AEs and clinical laboratory abnormalities (Parts 1B and 2 only)

Secondary Outcome Measures

Pharmacokinetic (PK) Profile of FPA144: Maximum Serum Concentration
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,
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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.
Duration of Response Per RECIST 1.1 (Part 2 Only)
Duration of complete or partial response with 95% confidence intervals in gastric cancer population.
Pharmacokinetic (PK) Profile of FPA144: Area Under Serum Concentration-time Curve
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,

Full Information

First Posted
November 25, 2014
Last Updated
December 9, 2021
Sponsor
Five Prime Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02318329
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Five Prime Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumors, Gastric Cancer, Transitional Cell Carcinoma of the Bladder
Keywords
FGFR2b, FGFR2, FGFR, bladder neoplasms, esophageal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1A: FPA144 Dose Escalation Solid Tumors
Arm Type
Experimental
Arm Description
Dose escalation of FPA144 (0.3 mg/kg to 15 mg/kg)
Arm Title
Part 1B: FPA144 Dose Escalation Gastric Cancer
Arm Type
Experimental
Arm Description
Dose escalation of FPA144 (3-10 mg/kg) in patients with gastric cancer
Arm Title
Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors
Arm Type
Experimental
Arm Description
Evaluation of objective responses in patients with tumors with various levels of FGFR2b overexpression
Intervention Type
Drug
Intervention Name(s)
FPA144
Other Intervention Name(s)
Bemarituzumab
Intervention Description
FPA144 will be administered by IV infusion over approximately 30 minutes every 2 weeks.
Primary Outcome Measure Information:
Title
Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only).
Description
Number of participants with grade 3 and grade 4 adverse events (AE) and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs)
Time Frame
4 weeks on average
Title
Number of Participants With AEs and Clinical Laboratory Abnormalities (Parts 1B and 2 Only)
Description
Number of Participants with AEs and clinical laboratory abnormalities (Parts 1B and 2 only)
Time Frame
16 weeks on average
Secondary Outcome Measure Information:
Title
Pharmacokinetic (PK) Profile of FPA144: Maximum Serum Concentration
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,
Time Frame
16 weeks on average
Title
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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.
Time Frame
16 weeks on average
Title
Duration of Response Per RECIST 1.1 (Part 2 Only)
Description
Duration of complete or partial response with 95% confidence intervals in gastric cancer population.
Time Frame
16 weeks on average
Title
Pharmacokinetic (PK) Profile of FPA144: Area Under Serum Concentration-time Curve
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,
Time Frame
16 weeks on average

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Lead
Organizational Affiliation
Five Prime Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center, Mission Bay
City
San Francisco
State/Province
California
ZIP/Postal Code
74158
Country
United States
Facility Name
Innovative Cancer Research Institute
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
The University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Sarah Cannon Research Institute, LLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
The University of Texas M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
South Texas Accelerated Research Therapeutics, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Chonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-do
ZIP/Postal Code
561-712
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified data will be provided to investigative sites requesting information for secondary publication.
IPD Sharing Time Frame
After publication of the primary endpoint results.
IPD Sharing Access Criteria
Participating investigators in good standing.
Citations:
PubMed Identifier
31094225
Citation
Catenacci DV, Tesfaye A, Tejani M, Cheung E, Eisenberg P, Scott AJ, Eng C, Hnatyszyn J, Marina N, Powers J, Wainberg Z. Bemarituzumab with modified FOLFOX6 for advanced FGFR2-positive gastroesophageal cancer: FIGHT Phase III study design. Future Oncol. 2019 Jun;15(18):2073-2082. doi: 10.2217/fon-2019-0141. Epub 2019 May 16.
Results Reference
background
PubMed Identifier
32965540
Citation
Xiang H, Liu L, Gao Y, Ahene A, Macal M, Hsu AW, Dreiling L, Collins H. Population pharmacokinetic analysis of phase 1 bemarituzumab data to support phase 2 gastroesophageal adenocarcinoma FIGHT trial. Cancer Chemother Pharmacol. 2020 Nov;86(5):595-606. doi: 10.1007/s00280-020-04139-4. Epub 2020 Sep 23.
Results Reference
derived
PubMed Identifier
32167861
Citation
Catenacci DVT, Rasco D, Lee J, Rha SY, Lee KW, Bang YJ, Bendell J, Enzinger P, Marina N, Xiang H, Deng W, Powers J, Wainberg ZA. Phase I Escalation and Expansion Study of Bemarituzumab (FPA144) in Patients With Advanced Solid Tumors and FGFR2b-Selected Gastroesophageal Adenocarcinoma. J Clin Oncol. 2020 Jul 20;38(21):2418-2426. doi: 10.1200/JCO.19.01834. Epub 2020 Mar 13.
Results Reference
derived

Learn more about this trial

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

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