Phase
Condition
Neoplasms
Treatment
Anticancer Agents
BG-C137
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically or cytologically confirmed advanced or metastatic solid tumors.
Life expectancy of ≥ 3 months.
Prior standard systemic therapy in the advanced or metastatic setting. DoseEscalation: Participants for whom further standard treatment is not available, nottolerated or determined not appropriate based on the investigator's judgment. ComboDose Confirmation, Combo Safety Expansion, and Dose Expansion: Participants who havereceived at least 1 or 2 prior lines of systemic therapy, which included afluoropyrimidine and/or a platinum in the advanced or metastatic setting
Tumors with FGFR2b expression/ or FGFR2 gene amplification. Participants mustprovide agreement for collection of archival tissue or recently obtained fresh tumorbiopsy for central evaluation of FGFR2b expression levels and other biomarkerassessments.
≥ 1 measurable lesion per RECIST v1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Adequate organ function as determined per protocol.
Exclusion
Exclusion Criteria:
Prior exposure to topoisomerase I inhibitor (TOP1i)-based antibody-drug conjugate (ADC) therapies or FGFR2b-targeted ADC therapies.
Active or chronic corneal disorder, history of corneal transplantation, cornealkeratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation orulceration, other active ocular conditions and any clinically significant cornealdisease that prevents adequate monitoring of drug-induced keratopathy.
Spinal cord compression, or active leptomeningeal disease or uncontrolled, untreatedbrain metastasis.
Systemic antitumor therapy (including targeted therapy and immunotherapy ≤ 14 days, ≤ 28 days for immuno- oncological antibody, ≤ 14 days or 5 half-lives [whichever isshorter] for chemotherapy, ADCs, or investigational therapy) before first dose ofstudy drug(s).
Toxicities due to prior therapy that have not recovered.
Any malignancy ≤ 2 years before first dose of study drug(s) except for the specificcancer under investigation in this study and any locally recurring cancer that hasbeen treated curatively.
History of interstitial lung disease (ILD), noninfectious pneumonitis, oxygensaturation at rest < 92%, or requirement for supplemental oxygen at baseline.
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales NSW 2148
AustraliaActive - Recruiting
Liverpool Hospital
Liverpool, New South Wales NSW 2170
AustraliaActive - Recruiting
Icon Cancer Centre South Brisbane
South Brisbane, Queensland QLD 4101
AustraliaActive - Recruiting
Monash Health
Clayton, Victoria VIC 3168
AustraliaActive - Recruiting
Cabrini Hospital Malvern
Malvern, Victoria VIC 3144
AustraliaActive - Recruiting
Cabrini Hospital Malvern
Malvern East, Victoria 3144
AustraliaActive - Recruiting
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui 233004
ChinaActive - Recruiting
Anhui Provincial Hospital
Hefei, Anhui 230000
ChinaActive - Recruiting
The Second Hospital of Anhui Medical University
Hefei, Anhui 230601
ChinaActive - Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality 100142
ChinaActive - Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality 100050
ChinaActive - Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian 350001
ChinaActive - Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian 361003
ChinaActive - Recruiting
Zhongshan Hospital Xiamen University
Xiamen, Fujian 361004
ChinaActive - Recruiting
Guangxi Medical University Cancer Hospital Wuxiang Branch
Nanning, Guangxi 530201
ChinaActive - Recruiting
The Tumor Hospital Affiliated to Guangxi Medical Universitywuxiang Branch
Nanning, Guangxi 530201
ChinaActive - Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei 050011
ChinaActive - Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang 150000
ChinaActive - Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan 471003
ChinaActive - Recruiting
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan 453100
ChinaActive - Recruiting
Henan Cancer Hospital
Zhengzhou, Henan 450000
ChinaActive - Recruiting
Hubei Cancer Hospital
Wuhan, Hubei 430079
ChinaActive - Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu 210029
ChinaActive - Recruiting
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu 210008
ChinaActive - Recruiting
Affiliated Hospital of Jiangnan University South Campus
Wuxi, Jiangsu 214122
ChinaActive - Recruiting
The Affiliated Hospital of Xuzhou Medical University Kunpeng Road Branch
Xuzhou, Jiangsu 221000
ChinaActive - Recruiting
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning 110042
ChinaActive - Recruiting
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi 710061
ChinaActive - Recruiting
Shandong Cancer Hospital
Jinan, Shandong 250117
ChinaActive - Recruiting
The Affiliated Hospital of Qingdao University Branch North
Qingdao, Shandong 266000
ChinaActive - Recruiting
The Second Affiliated Hospital of Shandong First Medical University
Taian, Shandong 271099
ChinaActive - Recruiting
Weifang Peoples Hospital Beichen Branch
Weifang, Shandong 261057
ChinaActive - Recruiting
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality 200032
ChinaActive - Recruiting
Fudan University Shanghai Cancer Centerpudong
Shanghai, Shanghai Municipality 201321
ChinaActive - Recruiting
Shanghai East Hospital Branch Hospital
Shanghai, Shanghai Municipality 200123
ChinaActive - Recruiting
Shanghai East Hospital Branch Hospital
Shanghai 1796236, Shanghai Municipality 1796231 200123
ChinaActive - Recruiting
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi 046000
ChinaActive - Recruiting
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi 030013
ChinaActive - Recruiting
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan 610071
ChinaActive - Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality 300060
ChinaActive - Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang 310022
ChinaActive - Recruiting
Seoul National University Bundang Hospital
BundangGu SeongnamSi, Gyeonggi-do 13620
Korea, Republic ofActive - Recruiting
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi 06351
Korea, Republic ofActive - Recruiting
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi 03722
Korea, Republic ofActive - Recruiting
Severance Hospital Yonsei University Health System
Seoul, Seoul Teugbyeolsi 03722
Korea, Republic ofActive - Recruiting
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi 05505
Korea, Republic ofActive - Recruiting
Cha Bundang Medical Center, Cha University
BundangGu SeongnamSi, Gyeonggi-do 13496
South KoreaActive - Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do 13620
South KoreaActive - Recruiting
Seoul National University Bundang Hospital
BundangGu SeongnamSi, Gyeonggi-do 1841610 13620
South KoreaActive - Recruiting
Kyungpook National University Chilgok Hospital
BukGu, Gyeongsangbukdo 41404
South KoreaActive - Recruiting
Gachon University Gil Medical Center
NamdongGu, Incheon Gwang'yeogsi 21565
South KoreaActive - Recruiting
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi 06351
South KoreaActive - Recruiting
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi 03722
South KoreaActive - Recruiting
Gangnam Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi 06273
South KoreaActive - Recruiting
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi 03080
South KoreaActive - Recruiting
Seoul National University Hospital
Seoul 1835848, Seoul Teugbyeolsi 03080
South KoreaActive - Recruiting
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi 05505
South KoreaActive - Recruiting
Usc Norris Comprehensive Cancer Center (Nccc)
Los Angeles, California 90089-1019
United StatesActive - Recruiting
Yale Cancer Center
New Haven, Connecticut 06510
United StatesActive - Recruiting
Mayo Clinic Rochester
Rochester, Minnesota 55905-0001
United StatesCompleted
Md Anderson Cancer Center
Houston, Texas 77030-3907
United StatesActive - Recruiting
Fred Hutchinson Cancer Research Center
Seattle, Washington 98109-4433
United StatesActive - Recruiting
University of Wisconsin
Madison, Wisconsin 53792-0001
United StatesActive - Recruiting

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