Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma

August 12, 2024 updated by: LianBio LLC

A Phase II, Multicenter, Open-Label, Single Arm Study of Oral Infigratinib Monotherapy in Patients With Locally Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma, Who Harboring FGFR2 Gene Amplification

This is a multicenter, open-label, single arm phase II study to evaluate the efficacy and safety of Infigratinib in patients with locally advanced or metastatic GC or GEJ patient with FGFR2 gene amplification, who have failed at least 2 lines of previous standard systemic treatment .

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230601
        • The Second Hospital of Anhui Medical University
      • Hefei, Anhui, China, 230031
        • Anhui Provincial Cancer Hospital
    • Beijing
      • Beijing, Beijing, China, 100142
        • Beijing Cancer Center
    • Fujian
      • Xiamen, Fujian, China
        • The First Affiliated Hospital of Xiamen University
    • Gansu
      • Lanzhou, Gansu, China, 730030
        • The Second Hospital Lanzhou University
    • Guangdong
      • Dongguan, Guangdong, China, 523059
        • Dongguan City People's Hospital
      • Guangzhou, Guangdong, China, 510180
        • Guangzhou First People's Hospital
      • Guangzhou, Guangdong, China, 510655
        • The Sixth Affiliated Hospital, Sun Yat-sen University
    • Guangxi
      • Guilin, Guangxi, China, 541199
        • The Second Affiliated Hospital of Guilin Medical University
      • Liuzhou, Guangxi, China, 545006
        • Liuzhou People's Hospital
    • Hebei
      • Baoding, Hebei, China, 071030
        • Affiliated Hospital of Hebei University
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Harbin Medical University Cancer Hospital
    • Henan
      • Zhengzhou, Henan, China, 450052
        • The First Affiliated Hospital of Zhengzhou University
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Hubei Cancer Hospital
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital, Tongji Medical College of Hust
    • Hunan
      • Changsha, Hunan, China, 410002
        • Hunan Provincial People's Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Nanjing Drum Tower Hospital
    • Jilin
      • Changchun, Jilin, China, 130012
        • Jilin Cancer Hospital
    • Liaoning
      • Shenyang, Liaoning, China, 110002
        • The First Hospital of China Medical University
    • Shaanxi
      • Xi'an, Shaanxi, China
        • The First Affiliated Hospital of Xi'an Jiaotong University
    • Shandong
      • Jinan, Shandong, China, 250013
        • Central Hospital Affiliated to Shandong First Medical University
      • Jinan, Shandong, China, 250117
        • Shandong Provincial Cancer Hosptial
      • Qingdao, Shandong, China, 266000
        • The Affiliated Hospital Of Qingdao University
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Zhongshan Hospital Fudan University
    • Shanxi
      • Taiyuan, Shanxi, China, 030013
        • Shanxi Provincial Cancer Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital of Sichuan University
      • Chengdu, Sichuan, China, 610042
        • Sichuan Cancer Hospital
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Tianjin Medical University Cancer Institute&Hospital
    • Yunnan
      • Kunming, Yunnan, China, 650118
        • Yunnan Cancer Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310013
        • The First Affiliated Hospital Zhejiang University School Of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years and older
  • Histologically or cytologically confirmed locally advanced or metastatic gastric adenocarcinoma, or gastroesophageal junction adenocarcinoma.
  • Failed at least 2 lines of prior systemic therapy
  • Willing to undergo tumor biopsy or provide FFPE samples for central lab testing.
  • At least one measurable tumor lesion by RECIST v1.1
  • Eastern cooperative oncology group (ECOG) performance status of 0 or 1.
  • Life expectancy ≥3 months.
  • Willing to participate in this study and sign informed consent form, able to read and understand the study, follow the procedures.

Exclusion Criteria:

  • History of other primary malignancies within 3 years except adequately treated in situ carcinoma of the cervix or non-melanoma carcinoma of the skin or any other curatively treated malignancy that is not expected to require treatment for recurrence during the study.
  • Previous or current treatment of a mitogen-activated protein kinase (MAPK-MEK) or selective FGFR inhibitor.
  • Any known hypersensitivity to infigratinib or its excipients.
  • History and/or current evidence of extensive tissue calcification.
  • Current evidence of endocrine alterations of calcium/phosphate homeostasis.
  • Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral infigratinib (such as, ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).14. Laboratory abnormality as defined in protocol.
  • Considered unsuitable to participate in the study by Investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Infigratinib
Infigratinib 125 mg orally daily, 3 weeks on, 1 week off. . In patients with mild liver function abnormalities or mild renal impairment, the starting dose is 100 mg.
Drug: Infigratinib
Infigratinib is a selective ATP-competitive inhibitor of fibroblast growth factor receptor (FGFR) 1-3 that inhibits FGFR downstream signaling and proliferation in human cancer cell lines with FGFR genetic alterations, significantly inhibiting the growth of several types of cancers driven by FGFR amplification, fusion and mutation.
Other Names:
  • BGJ398
  • BBP-831

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: Week9/17/25/33 and every 12 weeks after (up to 2 years)
ORR: the proportion of patients with confirmed complete response (CR) or partial response (PR), assessed by the independent review committee (IRC) according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1.
Week9/17/25/33 and every 12 weeks after (up to 2 years)
Duration of response (DoR)
Time Frame: Week9/17/25/33 and every 12 weeks after (up to 2 years)
DoR: the duration from the first evaluation as CR or PR to the first evaluation as progressive disease (PD) or death of any cause, per RECIST v1.1 assessed by investigator (INV) and IRC.
Week9/17/25/33 and every 12 weeks after (up to 2 years)
Disease control rate (DCR)
Time Frame: Week9/17/25/33 and every 12 weeks after (up to 2 years)
DCR: the proportion of patients whose overall response is confirmed to be CR or PR or stable disease (SD) per RECIST v1.1, assessed by INV and IRC.
Week9/17/25/33 and every 12 weeks after (up to 2 years)
Investigator evaluated ORR
Time Frame: Week9/17/25/33 and every 12 weeks after (up to 2 years)
the proportion of patients with confirmed CR or PR assessed by INV according to RECIST v1.1
Week9/17/25/33 and every 12 weeks after (up to 2 years)
Progression-free survival (PFS)
Time Frame: Week9/17/25/33 and every 12 weeks after (up to 2 years)
the duration from the first date of treatment to the date of progression or death due to any cause, assessed by INV and IRC
Week9/17/25/33 and every 12 weeks after (up to 2 years)
Overall survival (OS)
Time Frame: from the first date of Infigratinib treatment until date of death.
from the first date of Infigratinib treatment until date of death.
from the first date of Infigratinib treatment until date of death.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LianBio LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2023

Primary Completion (Actual)

May 31, 2024

Study Completion (Actual)

May 31, 2024

Study Registration Dates

First Submitted

November 29, 2023

First Submitted That Met QC Criteria

January 4, 2024

First Posted (Actual)

January 16, 2024

Study Record Updates

Last Update Posted (Actual)

August 14, 2024

Last Update Submitted That Met QC Criteria

August 12, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LB1001-203

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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