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
Connect with a study center
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales NSW 2148
AustraliaSite Not Available
Liverpool Hospital
Liverpool, New South Wales NSW 2170
AustraliaSite Not Available
Blacktown Cancer and Haematology Centre
Blacktown 2175411, New South Wales 2155400 NSW 2148
AustraliaActive - Recruiting
Liverpool Hospital
Liverpool 2159851, New South Wales 2155400 NSW 2170
AustraliaActive - Recruiting
Icon Cancer Centre South Brisbane
South Brisbane, Queensland QLD 4101
AustraliaSite Not Available
Icon Cancer Centre South Brisbane
South Brisbane 2207259, Queensland 2152274 QLD 4101
AustraliaActive - Recruiting
Monash Health
Clayton, Victoria VIC 3168
AustraliaSite Not Available
Cabrini Hospital Malvern
Malvern, Victoria 3144
AustraliaSite Not Available
Cabrini Hospital Malvern
Malvern East, Victoria VIC 3144
AustraliaSite Not Available
Monash Health
Clayton 2171400, Victoria 2145234 VIC 3168
AustraliaActive - Recruiting
Cabrini Hospital Malvern
Malvern East 7932638, Victoria 2145234 VIC 3144
AustraliaActive - Recruiting
Beijing Cancer Hospital
Beijing, Beijing 100142
ChinaSite Not Available
Beijing Cancer Hospital
Beijing 1816670, Beijing Municipality 2038349 100142
ChinaActive - Recruiting
The Tumor Hospital Affiliated to Guangxi Medical Universitywuxiang Branch
Nanning 1799869, Guangxi 1809867 530201
ChinaActive - Recruiting
Harbin Medical University Cancer Hospital
Harbin 2037013, Heilongjiang 2036965 150000
ChinaActive - Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang 1801792, Henan 1808520 471003
ChinaActive - Recruiting
Henan Cancer Hospital
Zhengzhou 1784658, Henan 1808520 450000
ChinaActive - Recruiting
Hubei Cancer Hospital
Wuhan, Hubei 430079
ChinaSite Not Available
Hubei Cancer Hospital
Wuhan 1791247, Hubei 1806949 430079
ChinaActive - Recruiting
Affiliated Hospital of Jiangnan University South Campus
Wuxi 1790923, Jiangsu 1806260 214122
ChinaActive - Recruiting
The Affiliated Hospital of Qingdao University Branch North
Qingdao, Shandong 266000
ChinaSite Not Available
The Affiliated Hospital of Qingdao University Branch North
Qingdao 1797929, Shandong 1796328 266000
ChinaActive - Recruiting
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai 200032
ChinaSite Not Available
Shanghai East Hospital Branch Hospital
Shanghai, Shanghai 200123
ChinaActive - Recruiting
Affiliated Zhongshan Hospital of Fudan University
Shanghai 1796236, Shanghai Municipality 1796231 200032
ChinaActive - Recruiting
Shanghai East Hospital Branch Hospital
Shanghai 1796236, Shanghai Municipality 1796231 200123
ChinaActive - Recruiting
Shanxi Provincial Cancer Hospital
Taiyuan 1793511, Shanxi 1795912 030013
ChinaActive - Recruiting
National Cancer Center Hospital East
Kashiwa 1859924, Chiba 2113014 277-8577
JapanSite Not Available
National Cancer Center Hospital
ChuoKu, Tokyo 1850144 104-0045
JapanSite Not Available
Cancer Institute Hospital of Jfcr
Kotoku, Tokyo 1850144 135-8550
JapanSite Not Available
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
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi 03080
Korea, Republic ofSite Not Available
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
Seoul National University Bundang Hospital
Seongnam-si, 13620
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
BundangGu SeongnamSi, Gyeonggi-do 1841610 13620
South KoreaActive - Recruiting
Kyungpook National University Chilgok Hospital
BukGu, Gyeongsangbukdo 41404
South KoreaSite Not Available
Gachon University Gil Medical Center
NamdongGu, Incheon Gwang'yeogsi 21565
South KoreaSite Not Available
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 1835848, Seoul Teugbyeolsi 06273
South KoreaSite Not Available
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 StatesSite Not Available
Usc Norris Comprehensive Cancer Center (Nccc)
Los Angeles 5368361, California 5332921 90089-1019
United StatesActive - Recruiting
Yale Cancer Center
New Haven, Connecticut 06520-8028
United StatesSite Not Available
Yale Cancer Center
New Haven 4839366, Connecticut 4831725 06520-8028
United StatesActive - Recruiting
Mayo Clinic Rochester
Rochester, Minnesota 55905-0001
United StatesSite Not Available
Mayo Clinic Rochester
Rochester 5043473, Minnesota 5037779 55905-0001
United StatesActive - Recruiting
Md Anderson Cancer Center
Houston, Texas 77030-3907
United StatesSite Not Available
Md Anderson Cancer Center
Houston 4699066, Texas 4736286 77030-3907
United StatesActive - Recruiting
Fred Hutchinson Cancer Research Center
Seattle, Washington 98109-4433
United StatesSite Not Available
Fred Hutchinson Cancer Research Center
Seattle 5809844, Washington 5815135 98109-4433
United StatesActive - Recruiting
University of Wisconsin
Madison, Wisconsin 53792-0001
United StatesSite Not Available
University of Wisconsin
Madison 5261457, Wisconsin 5279468 53792-0001
United StatesActive - Recruiting
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