RecruitingPhase 2NCT06632262

A Phase 2 Clinical Study of ABSK061 and ABSK043

An Open-label Phase 2, Multicenter, Open-Label Clinical Study to Evaluate the Safety and Efficacy of ABSK061 and ABSK043 with or Without Chemotherapy in Patients with Metastatic/Unresectable Solid Tumors with FGFR2/3 Alterations

Sponsor

Abbisko Therapeutics Co, Ltd

Enrollment

202 participants

Start Date

Nov 13, 2024

Study Type

INTERVENTIONAL

Conditions

Urothelial Carcinoma HER2-Gastric/Gastroesophageal Junction Cancer

Summary

The purpose of this study is to evaluate the anti-tumor activity of ABSK061 + ABSK043 in terms of overall response rate (ORR) in in Patients with Metastatic/Unresectable Solid Tumors with FGFR2/3 Alterations

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 2 study is testing a combination of two drugs — ABSK061 and ABSK043 — in people with advanced solid tumors (including stomach cancer, bladder cancer, lung cancer, and others) whose tumors have specific changes in genes called FGFR2 or FGFR3. **You may be eligible if...** - You have metastatic or inoperable solid tumors confirmed by biopsy - Your tumor has a confirmed FGFR2 or FGFR3 gene alteration (mutation, fusion, or amplification) - For stomach cancer: HER2-negative, with FGFR2 amplification, and have had no prior or only one prior systemic treatment - For bladder cancer: specific FGFR3 mutation or fusion confirmed, with limited prior therapy - For lung cancer: FGFR2/3 alteration confirmed, with prior standard or targeted therapy - Your overall health allows participation (measurable disease, adequate organ function) **You may NOT be eligible if...** - You have previously received an FGFR pathway inhibitor - You have active autoimmune disease requiring treatment - You have significant lung disease or recent serious immune-related side effects from prior therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGABSK061 + ABSK043

Participants with fibroblast growth factor receptor (FGFR) mutations and FGFR gene fusions will receive a dose of ABSK061 + ABSK043 oral capsule until disease progression, intolerable toxicity, withdrawal of consent, decision by the investigator to discontinue treatment, or end of data collection timepoint if there is clinical benefit in the opinion of the investigator, has been achieved.

DRUGABSK061+ABSK043 in combination with CAPOX

Participants with HER2-Gastric/Gastroesophageal Junction Cancer and fibroblast growth factor receptor 2( FGFR2 ) amplification and overexpression will receive a dose of ABSK061 + ABSK043 oral capsule in combination with CAPOX until disease progression, intolerable toxicity, withdrawal of consent, decision by the investigator to discontinue treatment, or end of data collection timepoint if there is clinical benefit in the opinion of the investigator, has been achieved.

Locations(21)

Guizhou Provincial People'S Hospital

Guiyang, Guizhou, China

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Heibei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Hunan Central Hospital

Changsha, Hunan, China

Jiangxi Cance Hospital

Nanchang, Jiangxi, China

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, China

Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

ZhongShan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Xiangyang Central Hospital

Xiangyang, Sichuang, China

Changzhi People's Hospital

Changzhi, China

West China Hospital, Sichuan University

Chengdu, China

The First Hospital of China Medical University

Hangzhou, China

Zhejiang Provincial People'S Hospital

Hangzhou, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

Wuhan, China

First Hospital of Shanxi Medical University

Xi'an, China

Shanxi Cancer hospital (Shanxi Cancer institute)

Xi'an, China

First Affiliated Hospital of Xiamen University

Xiamen, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, China

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