Infigratinib in Subjects With GC or GEJ With FGFR2 Amplification or Other Solid Tumors With Other FGFR Alterations (FGFR)

June 22, 2022 updated by: LianBio LLC

A Phase IIa of Infigratinib in Subjects With Locally Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma With FGFR2 Amplification or Other Advanced Solid Tumors With Other FGFR Alterations

Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor (FGFR) 1-3. This is a multicenter, open-label, single arm phase IIa study to evaluate the efficacy and safety of Infigratinib in subjects with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 genetic amplification or other advanced solid tumors with other FGFR genetic alternations who have failed in 2nd line or above treatment. This trial includes 2 cohorts (i.e., baskets) with above mentioned indications.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The subject will go through 4 periods, including Pre-screen period, screening period, treatment period and follow up period.

Pre-screening period (up to 28 days) For cohort 1, subject sign pre-screening ICF( Inform consent ), subject will do tumor biopsy or provide FFPE samples before prescreening for FGFR2-amp detection by FISH from the central laboratory. If the result is positive, subjects can go through the main screening stage, otherwise participants will be considered a prescreen failure. subjects can go through the main screening stage, otherwise participants will be considered a prescreen failure.

Screening period ( All cohorts; up to 28 days): Subjects who had positive genetic result could sign main ICF for all the screening examinations and establish study baseline documents. Only the eligible participants could enter the next treatment period.

Treatment period: Eligible subjects will be orally administered Infigratinib (125mg, QD) for 3 weeks on, 1-week off in each 28-day cycle until the occurrence of unacceptable toxicity, disease progression, withdrawing informed consent, death, contact lost, starting a new anticancer therapy, etc (whichever occurs first). During this period, subjects will be routinely assessed efficacy status by radiographic check at W9/W17/W25/W33 . After that, subjects will be evaluated every 12 weeks until disease progression. The safety assessment will be performed at cycle 1- 4;

Follow up period: Once a treatment discontinuation happens, subjects should return to the hospital within 30 days to receive a complete safety examination. Subjects with treatment discontinuation or disease progression should directly enter the follow-up period, visit approximately every 3 months for survival status reporting until withdrawing informed consent, death, contact lost, starting a new anti-cancer therapy, etc. (whichever occurs first).

Study Type

Interventional

Enrollment (Anticipated)

80

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 Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital ( Department of Thoracic Oncology )
        • Contact:
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital (Department of Gynecological Oncology)
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
          • Chunmei Shi, Master
          • Phone Number: 86 591 86218442
          • Email: scmfz@qq.com
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
          • Jianwei Yang, Bachelor
          • Phone Number: 86 591 83660063
          • Email: swzcq62@163.com
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • Recruiting
        • The Sixth Affiliated Hospital, Sun Yat-sen University
        • Contact:
    • Hebei
      • Baoding, Hebei, China, 071030
        • Recruiting
        • Affiliated Hospital of Hebei University
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
    • Hubei
      • Wuan, Hubei, China, 430079
        • Recruiting
        • Hubei Cancer Hospital
        • Contact:
          • Huiting Xu, Doctor
          • Phone Number: 86 27 87671530
          • Email: 2891533@qq.com
    • Jiangsu
      • Changzhou, Jiangsu, China, 213004
        • Recruiting
        • The First People's Hospital of Changzhou
        • Contact:
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110042
        • Recruiting
        • Liaoning Cancer Hospital & Institute
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200032
    • Shanxi
      • Taiyuan, Shanxi, China, 030013
        • Recruiting
        • Shanxi Provincial Cancer Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The First Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
      • Hangzhou, Zhejiang, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
        • Contact:
          • Hongming Pan, Doctor
          • Phone Number: 86 571 86006922
          • Email: shonco@sina.cn
    • Zhengzhou
      • Henan, Zhengzhou, China, 450008
        • Recruiting
        • Henan Cancer Hospital
        • Contact:

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Cohort 1 : 1) histologically or cytologically confirmed locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma. 2) failed 2nd line or above therapy with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma. 3) willing to do tumor biopsy for FGFR2 gene amplification via FISH test at central lab
  2. Cohort 2: 1) Histologically or cytologically confirmed locally advanced or metastatic solid tumors other than CHOL and UC. 2) Subjects must have failed established standard medical anti-cancer therapies for a diagnosed tumor or have been intolerant to such therapy, or no standard therapy, or in the opinion of the Investigator have been considered ineligible for a particular form of standard therapy on medical grounds.(3) Previous documented proof of FGFR1, FGFR2 ,or FGFR3 fusions/rearrangements and activating mutations (FISH/NGS/PCR results could be accepted) presented by local laboratory or central laboratory. [Except Cohort 1GC, or GEJ patients with FGFR2 amplification]
  3. Measurable disease by RECIST v1.1.
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Exclusion Criteria:

To be eligible for the study, subjects must not meet any of the following criteria:

  1. History of other primary malignancies within 3 years except adequately treated in situ carcinoma of the cervix or nonmelanoma carcinoma of the skin or any other curatively treated malignancy that is not expected to require treatment for recurrence during the course of the study.
  2. Previous or current treatment of a mitogen-activated protein kinase (MAPK-MEK) or selective FGFR inhibitor.
  3. Any known hypersensitivity to Infigratinib or its excipients.
  4. Subjects with symptomatic central nervous system metastasis.
  5. History and/or current evidence of extensive tissue calcification.
  6. Amylase or lipase >2.0 × ULN.
  7. Abnormal calcium or phosphorus, or calcium-phosphorus product ≥55 mg2/dL2.
  8. Current evidence of endocrine alterations of calcium/phosphate homeostasis.
  9. Current evidence of corneal or retinal disorder/keratopathy.
  10. Currently receiving or planning to receive treatment with agents or foods that are known strong inducers or inhibitors of CYP3A4 and medications which increase serum phosphorus and/or calcium concentration during this study. Subjects are not permitted to receive enzyme-inducing anti-epileptic drugs.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJ) with FGFR2 amplification
Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off (every 4 weeks as one treatment cycle).
Drug: Infigratinib
Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.
Other Names:
  • BGJ398
Experimental: Advanced Solid tumors[Exclude GC/GEJ Arm and CHOL,UC]with FGFR1-3 fusions/rearrangements/mutations
Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off (every 4 weeks as one treatment cycle).
Drug: Infigratinib
Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.
Other Names:
  • BGJ398

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Approximately 12 months after dosed
Defined as the proportion of subjects with confirmed responses of CR or PR; Tumor response status will be assessed by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Approximately 12 months after dosed

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of response (DOR)
Time Frame: Approximately 12 months after dosed
Defined as from the first evaluation as CR or PR to the first evaluation as PD or death of any cause (percent of subjects with ≥6 months, ≥9 months, and ≥12 months DOR will be reported).
Approximately 12 months after dosed
Disease Control Rate (DCR)
Time Frame: Approximately 12 months after dosed
Defined as the proportion of subjects whose best overall response is confirmed to be CR or PR or SD (RECIST v1.1).
Approximately 12 months after dosed
Best Overall Response (BOR)
Time Frame: Approximately 12 months after dosed
Defined as best response recorded from the start of the study treatment until the disease progression/recurrence
Approximately 12 months after dosed
Progression-free survival (PFS)
Time Frame: Approximately 12 months after dosed
Defined as the time from the first date of treatment to the date of progression determined by investigator or death due to any cause.
Approximately 12 months after dosed
Overall Survival (OS)
Time Frame: Approximately 24 months after dosed
Defined as the time from the first date of treatment until date of death.
Approximately 24 months after dosed
Incidence of Adverse Events
Time Frame: Approximately 24 months
The incidence of adverse events is defined as the proportion of the patients, who have adverse event(s) since the time of main informed consent.
Approximately 24 months
Incidence of Serious Adverse Events
Time Frame: Approximately 24 months
The incidence of serious adverse events is defined as the proportion of the patients, who have serious adverse event(s) since the time of main informed consent.
Approximately 24 months
Incidence of Laboratory Abnormalities
Time Frame: Approximately 24 months
Incidence of abnormal laboratory is defined as the proportion of patients who have abnormal laboratory value since the time of main informed consent.
Approximately 24 months
Maximum plasma concentration (Cmax)
Time Frame: Approximately 5 months.
To characterize the pharmacokinetic parameter Maximum plasma concentration (Cmax) of Infigratinib following oral administration of Infigratinib in patients
Approximately 5 months.
Area under the plasma concentration versus time curve (AUC)
Time Frame: Approximately 5 months.
To characterize the pharmacokinetic parameter Area under the plasma concentration versus time curve (AUC) of Infigratinib following oral administration of Infigratinib in patients.
Approximately 5 months.
Apparent total plasma clearance (CL/F)
Time Frame: Approximately 5 months.
To characterize the pharmacokinetic parameter Apparent total plasma clearance (CL/F) of Infigratinib following oral administration of Infigratinib in patients.
Approximately 5 months.
Terminal elimination half-life (t1/2)
Time Frame: Approximately 5 months.
To characterize the pharmacokinetic parameter Terminal elimination half-life (t1/2) of Infigratinib following oral administration of Infigratinib in patients.
Approximately 5 months.
Accumulation ratio (Racc)
Time Frame: Approximately 5 months.
To characterize the pharmacokinetic parameter Accumulation ratio (Racc) of Infigratinib following oral administration of Infigratinib in patients.
Approximately 5 months.

Collaborators and Investigators

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

Sponsor

LianBio LLC

Investigators

  • Study Director: Qiao Sun, Doctor, Shanghai LianBio Development Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

May 13, 2020

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

July 28, 2021

First Submitted That Met QC Criteria

August 19, 2021

First Posted (Actual)

August 25, 2021

Study Record Updates

Last Update Posted (Actual)

June 27, 2022

Last Update Submitted That Met QC Criteria

June 22, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LB1001-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

Clinical Trials on Gastric Cancer

Clinical Trials on Infigratinib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe