Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors
NCT ID: NCT02318329
Last Updated: 2024-06-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
79 participants
INTERVENTIONAL
2014-11-30
2019-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1A: FPA144 Dose Escalation Solid Tumors
Dose escalation of FPA144 (0.3 mg/kg to 15 mg/kg)
FPA144
FPA144 will be administered by IV infusion over approximately 30 minutes every 2 weeks.
Part 1B: FPA144 Dose Escalation Gastric Cancer
Dose escalation of FPA144 (3-10 mg/kg) in patients with gastric cancer
FPA144
FPA144 will be administered by IV infusion over approximately 30 minutes every 2 weeks.
Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors
Evaluation of objective responses in patients with tumors with various levels of FGFR2b overexpression
FPA144
FPA144 will be administered by IV infusion over approximately 30 minutes every 2 weeks.
Interventions
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FPA144
FPA144 will be administered by IV infusion over approximately 30 minutes every 2 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Five Prime Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Lead
Role: STUDY_DIRECTOR
Five Prime Therapeutics, Inc.
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center, Mission Bay
San Francisco, California, United States
Innovative Cancer Research Institute
Whittier, California, United States
The University of Chicago Medical Center
Chicago, Illinois, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Weill Cornell Medical Center
New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute, LLC
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul St. Mary's Hospital
Seoul, , South Korea
SMG-SNU Boramae Medical Center
Seoul, , South Korea
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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FPA144-001
Identifier Type: -
Identifier Source: org_study_id
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