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Brief Title: Infigratinib in Subjects With GC or GEJ With FGFR2 Amplification or Other Solid Tumors With Other FGFR Alterations
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
Study ID: NCT05019794
Brief Summary: 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.
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).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Beijing Cancer Hospital ( Department of Thoracic Oncology ), Beijing, Beijing, China
Beijing Cancer Hospital (Department of Gynecological Oncology), Beijing, Beijing, China
Beijing Cancer Hospital, Beijing, Beijing, China
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
Fujian Cancer Hospital, Fuzhou, Fujian, China
The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
Affiliated Hospital of Hebei University, Baoding, Hebei, China
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
Hubei Cancer Hospital, Wuan, Hubei, China
The First People's Hospital of Changzhou, Changzhou, Jiangsu, China
Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China
Liaoning Cancer Hospital & Institute, Shenyang, Liaoning, China
Zhongshan Hospital Fudan University, Shanghai, Shanghai, China
Shanxi Provincial Cancer Hospital, Taiyuan, Shanxi, China
The First Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Sir Run Run Shaw hospital, Zhejiang University school of Medicine, Hangzhou, Zhejiang, China
Henan Cancer Hospital, Henan, Zhengzhou, China
Name: Qiao Sun, Doctor
Affiliation: Shanghai LianBio Development Co., Ltd.
Role: STUDY_DIRECTOR