Gastric CancerPhase 2FGFRNCT05019794

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

A Phase 2 study testing Infigratinib in people with Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by LianBio LLC at 17 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Solid Tumor
What is being tested?: Infigratinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 17 sitesChina
Study dates: 13 May 2020to 30 Dec 2023
Phase: Phase 2
Are there results?: None posted in the registry

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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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
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]
Measurable disease by RECIST v1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Who cannot join

To be eligible for the study, subjects must not meet any of the following criteria:
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.
Previous or current treatment of a mitogen-activated protein kinase (MAPK-MEK) or selective FGFR inhibitor.
Any known hypersensitivity to Infigratinib or its excipients.
Subjects with symptomatic central nervous system metastasis.
History and/or current evidence of extensive tissue calcification.

Show all 11Show fewer

Amylase or lipase >2.0 × ULN.
Abnormal calcium or phosphorus, or calcium-phosphorus product ≥55 mg2/dL2.
Current evidence of endocrine alterations of calcium/phosphate homeostasis.
Current evidence of corneal or retinal disorder/keratopathy.
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.

Trial locations and contacts

17 sites in 1 country.

Lei Mu, Master contact

86 21 61329798

Lei.mu@lianbio.com

City, postcode or hospital

Sites recruiting now only

17 sites in 1 country

China17 sites, 17 recruiting

Affiliated Hospital of Hebei University
Baoding, Hebei, 071030
Aimin Zang, Master, 86 312 5983056, booszam@sina.com
Recruiting
Beijing Cancer Hospital ( Department of Thoracic Oncology )
Beijing, Beijing Municipality, 100142
Jun Zhao, Postdoctor, 86 10 88196456, ohjerry@163.com
Recruiting
Beijing Cancer Hospital (Department of Gynecological Oncology)
Beijing, Beijing Municipality, 100142
Yunong Gao, Master, 86 10 88196448, gao_fuke@126.com
Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Lin Shen, 86 10 88196340, doctorshenlin@sina.cn
Recruiting
The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213004
Haijiao Yan, Doctor, 86 519 68871192, haijiao8237@163.com
Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Chunmei Shi, Master, 86 591 86218442, scmfz@qq.com
Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Jianwei Yang, Bachelor, 86 591 83660063, swzcq62@163.com
Recruiting
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
Yanhong Deng, 86 20 38254084, 13925106525@163.com
Recruiting
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Haiping Jiang, Doctor, 86 571 87235657, jianghaiping75@163.com
Recruiting
Sir Run Run Shaw hospital, Zhejiang University school of Medicine
Hangzhou, Zhejiang, 310016
Hongming Pan, Doctor, 86 571 86006922, shonco@sina.cn
Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Yanqiao Zhang, Postdoctor, 86 451 86298220, yanqiaozhanggcp@163.com
Recruiting
Henan Cancer Hospital
Henan, Zhengzhou, 450008
Ning Li, Doctor, 86 371 56155233, lining97@126.com
Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Jia Wei, Doctor, 86 25 83106666, weijia_224@163.com
Recruiting
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Tianshu Liu, Doctor, 86 21 64041990, liu.tianshu@zs-hospital.sh.cn
Recruiting
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110042
Jingdong Zhang, Postdoctor, 86 24 31916392, 13804027878@163.com
Recruiting
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030013
Yusheng Wang, Doctor, 86 351 4651509, wangyusheng1972@163.com
Recruiting
Hubei Cancer Hospital
Wuan, Hubei, 430079
Huiting Xu, Doctor, 86 27 87671530, 2891533@qq.com
Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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).

Conditions: Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Solid Tumor
Being tested: Infigratinib
Keywords: Gastric Cancer, Receptors, Fibroblast Growth Factor, Gastroesophageal Junction, Solid tumor
Medical subject headings: Stomach Neoplasms, Acrocephalosyndactylia

What participants receive

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

InfigratinibDrug
Also called BGJ398
Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.

Study groups in NCT05019794
Study group	Role	What they receive
Gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJ) with FGFR2 amplification	Experimental	Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off (every 4 weeks as one treatment cycle). Receives: Drug: Infigratinib
Advanced Solid tumors[Exclude GC/GEJ Arm and CHOL,UC]with FGFR1-3 fusions/rearrangements/mutations	Experimental	Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off (every 4 weeks as one treatment cycle). Receives: Drug: Infigratinib

What is being measured

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

Objective Response Rate (ORR)
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
Measured: Approximately 12 months after dosed

Secondary outcomes (13)

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

Timeline

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

13 May 202030 Dec 2023

First posted25 Aug 2021
Study start13 May 2020
Primary completion30 Dec 2022 (estimated)
Study completion30 Dec 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Gastric CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05019794
Sponsor's protocol ID: LB1001-201
Acronym: FGFR
Status last verified: Jun 2022
First submitted: 28 Jul 2021
Last updated: 27 Jun 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Hierro C, Alsina M, Sanchez M, Serra V, Rodon J, Tabernero J. Targeting the fibroblast growth factor receptor 2 in gastric cancer: promise or pitfall? Ann Oncol. 2017 Jun 1;28(6):1207-1216. doi: 10.1093/annonc/mdx081.
PubMed 28327938
Xue WJ, Li MT, Chen L, Sun LP, Li YY. Recent developments and advances of FGFR as a potential target in cancer. Future Med Chem. 2018 Sep 1;10(17):2109-2126. doi: 10.4155/fmc-2018-0103. Epub 2018 Aug 1.
PubMed 30066580
Dienstmann R, Rodon J, Prat A, Perez-Garcia J, Adamo B, Felip E, Cortes J, Iafrate AJ, Nuciforo P, Tabernero J. Genomic aberrations in the FGFR pathway: opportunities for targeted therapies in solid tumors. Ann Oncol. 2014 Mar;25(3):552-563. doi: 10.1093/annonc/mdt419. Epub 2013 Nov 20.
PubMed 24265351
Su X, Zhan P, Gavine PR, Morgan S, Womack C, Ni X, Shen D, Bang YJ, Im SA, Ho Kim W, Jung EJ, Grabsch HI, Kilgour E. FGFR2 amplification has prognostic significance in gastric cancer: results from a large international multicentre study. Br J Cancer. 2014 Feb 18;110(4):967-75. doi: 10.1038/bjc.2013.802. Epub 2014 Jan 23.
PubMed 24457912
Zhang J, Tang PMK, Zhou Y, Cheng ASL, Yu J, Kang W, To KF. Targeting the Oncogenic FGF-FGFR Axis in Gastric Carcinogenesis. Cells. 2019 Jun 25;8(6):637. doi: 10.3390/cells8060637.
PubMed 31242658
Nogova L, Sequist LV, Perez Garcia JM, Andre F, Delord JP, Hidalgo M, Schellens JH, Cassier PA, Camidge DR, Schuler M, Vaishampayan U, Burris H, Tian GG, Campone M, Wainberg ZA, Lim WT, LoRusso P, Shapiro GI, Parker K, Chen X, Choudhury S, Ringeisen F, Graus-Porta D, Porter D, Isaacs R, Buettner R, Wolf J. Evaluation of BGJ398, a Fibroblast Growth Factor Receptor 1-3 Kinase Inhibitor, in Patients With Advanced Solid Tumors Harboring Genetic Alterations in Fibroblast Growth Factor Receptors: Results of a Global Phase I, Dose-Escalation and Dose-Expansion Study. J Clin Oncol. 2017 Jan 10;35(2):157-165. doi: 10.1200/JCO.2016.67.2048. Epub 2016 Nov 21.
PubMed 27870574
Yuan J, Gong J, Peng Z, Liu TS, Xu H, Yang J, Wei J, Jiang H, Deng Y, Wang Y, Qi C, Lyu C, Sun Q, Mu L, Song L, Zhang X, Shen L. Efficacy and safety of infigratinib in patients with refractory advanced gastric or gastroesophageal junction adenocarcinoma harboring FGFR2 gene amplification: a single-arm, multicenter phase 2 trial. Br J Cancer. 2026 Jun 23. doi: 10.1038/s41416-026-03511-0. Online ahead of print.
PubMed 42337043

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05019794
Acronym / sponsor ID: FGFR / LB1001-201
Conditions: Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Solid Tumor
Keywords: Gastric Cancer, Receptors, Fibroblast Growth Factor, Gastroesophageal Junction, Solid tumor
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 80 participants (estimated)
Lead sponsor: LianBio LLCIndustry (pharma, biotech, devices)
Study start: 13 May 2020 (actual)
Primary completion: 30 Dec 2022 (estimated)
Study completion: 30 Dec 2023 (estimated)
First posted: 25 Aug 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

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

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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
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]
Measurable disease by RECIST v1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Key exclusion criteria (11 listed)

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.
Previous or current treatment of a mitogen-activated protein kinase (MAPK-MEK) or selective FGFR inhibitor.
Any known hypersensitivity to Infigratinib or its excipients.
Subjects with symptomatic central nervous system metastasis.
History and/or current evidence of extensive tissue calcification.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
InfigratinibAlso: BGJ398Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.	Drug	Advanced Solid tumors[Exclude GC/GEJ Arm and CHOL,UC]with FGFR1-3 fusions/rearrangements/mutations, Gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJ) with FGFR2 amplification

Primary outcome

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

13 secondary outcomes

Duration of response (DOR)
Time frame: Approximately 12 months after dosed
Disease Control Rate (DCR)
Time frame: Approximately 12 months after dosed
Best Overall Response (BOR)
Time frame: Approximately 12 months after dosed
Progression-free survival (PFS)
Time frame: Approximately 12 months after dosed
Overall Survival (OS)
Time frame: Approximately 24 months after dosed
Incidence of Adverse Events
Time frame: Approximately 24 months
Incidence of Serious Adverse Events
Time frame: Approximately 24 months
Incidence of Laboratory Abnormalities
Time frame: Approximately 24 months
Maximum plasma concentration (Cmax)
Time frame: Approximately 5 months.
Area under the plasma concentration versus time curve (AUC)
Time frame: Approximately 5 months.
Apparent total plasma clearance (CL/F)
Time frame: Approximately 5 months.
Terminal elimination half-life (t1/2)
Time frame: Approximately 5 months.
Accumulation ratio (Racc)
Time frame: Approximately 5 months.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
Background: PubMed 28327938Hierro C, Alsina M, Sanchez M, Serra V, Rodon J, Tabernero J. Targeting the fibroblast growth factor receptor 2 in gastric cancer: promise or pitfall? Ann Oncol. 2017 Jun 1;28(6):1207-1216. doi: 10.1093/annonc/mdx081.
Background: PubMed 30066580Xue WJ, Li MT, Chen L, Sun LP, Li YY. Recent developments and advances of FGFR as a potential target in cancer. Future Med Chem. 2018 Sep 1;10(17):2109-2126. doi: 10.4155/fmc-2018-0103. Epub 2018 Aug 1.
Background: PubMed 24265351Dienstmann R, Rodon J, Prat A, Perez-Garcia J, Adamo B, Felip E, Cortes J, Iafrate AJ, Nuciforo P, Tabernero J. Genomic aberrations in the FGFR pathway: opportunities for targeted therapies in solid tumors. Ann Oncol. 2014 Mar;25(3):552-563. doi: 10.1093/annonc/mdt419. Epub 2013 Nov 20.
Background: PubMed 24457912Su X, Zhan P, Gavine PR, Morgan S, Womack C, Ni X, Shen D, Bang YJ, Im SA, Ho Kim W, Jung EJ, Grabsch HI, Kilgour E. FGFR2 amplification has prognostic significance in gastric cancer: results from a large international multicentre study. Br J Cancer. 2014 Feb 18;110(4):967-75. doi: 10.1038/bjc.2013.802. Epub 2014 Jan 23.
Background: PubMed 31242658Zhang J, Tang PMK, Zhou Y, Cheng ASL, Yu J, Kang W, To KF. Targeting the Oncogenic FGF-FGFR Axis in Gastric Carcinogenesis. Cells. 2019 Jun 25;8(6):637. doi: 10.3390/cells8060637.
Background: PubMed 27870574Nogova L, Sequist LV, Perez Garcia JM, Andre F, Delord JP, Hidalgo M, Schellens JH, Cassier PA, Camidge DR, Schuler M, Vaishampayan U, Burris H, Tian GG, Campone M, Wainberg ZA, Lim WT, LoRusso P, Shapiro GI, Parker K, Chen X, Choudhury S, Ringeisen F, Graus-Porta D, Porter D, Isaacs R, Buettner R, Wolf J. Evaluation of BGJ398, a Fibroblast Growth Factor Receptor 1-3 Kinase Inhibitor, in Patients With Advanced Solid Tumors Harboring Genetic Alterations in Fibroblast Growth Factor Receptors: Results of a Global Phase I, Dose-Escalation and Dose-Expansion Study. J Clin Oncol. 2017 Jan 10;35(2):157-165. doi: 10.1200/JCO.2016.67.2048. Epub 2016 Nov 21.
Derived from this study: PubMed 42337043Yuan J, Gong J, Peng Z, Liu TS, Xu H, Yang J, Wei J, Jiang H, Deng Y, Wang Y, Qi C, Lyu C, Sun Q, Mu L, Song L, Zhang X, Shen L. Efficacy and safety of infigratinib in patients with refractory advanced gastric or gastroesophageal junction adenocarcinoma harboring FGFR2 gene amplification: a single-arm, multicenter phase 2 trial. Br J Cancer. 2026 Jun 23. doi: 10.1038/s41416-026-03511-0. Online ahead of print.
To describe the FGFR2 plays a key role in gastric cancer pathogenesis. FGFR inhibitors have been tested in FGFR-aberrant GC patients. Efforts should be done to identify reliant predictive biomarkers for selecting patients most likely to benefit.Link provided by the sponsor.
To describe the basic knowledge regarding FGF/FGFR signaling and categorize the clinical FGFR inhibitors. The mechanisms of resistance to FGFR inhibitors and corresponding strategies of overcoming drug resistance will also be discussed.Link provided by the sponsor.
Strengthening the role of FGFR signaling in cancer biology and providing more possibilities for the therapeutic application of FGFR inhibitorsLink provided by the sponsor.
A similar incidence of FGFR2 amplification was found in Asian and UK GCs and was associated with lymphatic invasion and poor prognosis.Link provided by the sponsor.
The pathogenic mechanisms of FGF-FGFR signaling in gastric adenocarcinoma together with the current targeted strategies in aberrant FGF-FGFR activated GC cases.Link provided by the sponsor.
Evaluation of BGJ398, a Fibroblast Growth Factor Receptor 1-3 Kinase Inhibitor, in Patients With Advanced Solid Tumors Harboring Genetic Alterations in Fibroblast Growth Factor Receptors: Results of a Global Phase I StuLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lei Mu, Master contact

86 21 61329798

Lei.mu@lianbio.com

Qiao Sun, Doctor study director

Shanghai LianBio Development Co., Ltd.

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Infigratinib in people with Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by LianBio LLC at 17 sites in China.

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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Lei Mu, Master (86 21 61329798, Lei.mu@lianbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Approximately 12 months after dosed). 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 NCT05019794, which also lists 7 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 27 Jun 2022.