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Advanced Solid TumorsPhase 1NCT02318329

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

A Phase 1 study testing FPA144 in people with Advanced Solid Tumors and Gastric Cancer, run by Five Prime Therapeutics, Inc. at 26 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
FPA144
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
26 sitesin 3 countries
Study dates
Nov 2014to 30 Jun 2019
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

26 sites in 3 countries.

26 sites in 3 countries

United States13 sites

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • The University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

  • Sarah Cannon Research Institute, LLC

    Nashville, Tennessee, 37203

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Weill Cornell Medical Center

    New York, New York, 10065

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • South Texas Accelerated Research Therapeutics, LLC

    San Antonio, Texas, 78229

  • UCSF Helen Diller Family Comprehensive Cancer Center, Mission Bay

    San Francisco, California, 74158

  • Innovative Cancer Research Institute

    Whittier, California, 90603

Other trials in United States

South Korea9 sites

  • Chonbuk National University Hospital

    Jeonju, Jeollabuk-do, 561-712

  • Seoul National University Bundang Hospital

    Seongnam-si, 463-707

  • Seoul National University Hospital

    Seoul, 110-744

  • Severance Hospital, Yonsei University

    Seoul, 120-752

  • Samsung Medical Center

    Seoul, 135-710

  • Gangnam Severance Hospital

    Seoul, 135-720

  • Korea University Anam Hospital

    Seoul, 136-705

  • Seoul St. Mary's Hospital

    Seoul, 137-701

  • SMG-SNU Boramae Medical Center

    Seoul, 156-707

Other trials in South Korea

Taiwan4 sites

  • China Medical University Hospital

    Taichung, 40447

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

About this study

Official title: A Phase 1 Open-Label, Dose-Finding Study Evaluating Safety and Pharmacokinetics of FPA144 in Patients With Advanced Solid Tumors

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.

Read the 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.

Being tested
FPA144
Keywords
FGFR2b, FGFR2, FGFR, bladder neoplasms, esophageal cancer
Medical subject headings
Stomach Neoplasms, Urinary Bladder Neoplasms, Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FPA144Drug

    Also called Bemarituzumab

    FPA144 will be administered by IV infusion over approximately 30 minutes every 2 weeks.

Study groups in NCT02318329
Study groupRoleWhat they receive
Part 1A: FPA144 Dose Escalation Solid TumorsExperimentalDose escalation of FPA144 (0.3 mg/kg to 15 mg/kg)
Receives: Drug: FPA144
Part 1B: FPA144 Dose Escalation Gastric CancerExperimentalDose escalation of FPA144 (3-10 mg/kg) in patients with gastric cancer
Receives: Drug: FPA144
Part 2: FPA144 Dose Expansion Gastric or Other Solid TumorsExperimentalEvaluation of objective responses in patients with tumors with various levels of FGFR2b overexpression
Receives: Drug: FPA144

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 4 weeks on average

  2. 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)

    Measured: 16 weeks on average

Secondary outcomes (4)

  1. 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,

    Measured: 16 weeks on average

  2. 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.

    Measured: 16 weeks on average

  3. Duration of Response Per RECIST 1.1 (Part 2 Only)

    Duration of complete or partial response with 95% confidence intervals in gastric cancer population.

    Measured: 16 weeks on average

  4. 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,

    Measured: 16 weeks on average

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2014 (estimated)
  2. Study startNov 2014
  3. Primary completion28 Feb 2019
  4. Study completion30 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02318329
Sponsor's protocol ID
FPA144-001
Status last verified
Dec 2021
First submitted
25 Nov 2014
Last updated
4 Jun 2024
Data monitoring committee
Yes
Individual data sharing
Yes: Deidentified data will be provided to investigative sites requesting information for secondary publication.

Publications

  • 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.

    PubMed 31094225

  • 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.

    PubMed 32167861

  • 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.

    PubMed 32965540

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FPA144 in people with Advanced Solid Tumors and Gastric Cancer, run by Five Prime Therapeutics, Inc. at 26 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only). (time frame: 4 weeks on average). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02318329, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.

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