Phase
Condition
Neoplasms
Treatment
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. SafetyExpansion and Dose Expansion: Participants who have received 1 or 2 prior lines ofsystemic therapy in the advanced or metastatic setting.
Participants must provide agreement for collection of archival tissue or recentlyobtained fresh tumor biopsy for central evaluation of FGFR2b expression levels andother biomarker assessments.
≥ 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, keratoconjuntivitis, 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 2148
AustraliaActive - Recruiting
Liverpool Hospital
Liverpool, New South Wales 2170
AustraliaActive - Recruiting
Icon Cancer Centre South Brisbane
South Brisbane, Queensland 4101
AustraliaActive - Recruiting
Monash Health
Clayton, Victoria 3168
AustraliaActive - Recruiting
Cabrini Hospital Malvern
Malvern, Victoria 3144
AustraliaSite Not Available
Cabrini Hospital Malvern
Malvern East, Victoria 3144
AustraliaActive - Recruiting
Beijing Cancer Hospital
Beijing, Beijing 100142
ChinaActive - Recruiting
Hubei Cancer Hospital
Wuhan, Hubei 430079
ChinaActive - Recruiting
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai 200032
ChinaActive - Recruiting
Shanghai East Hospital Branch Hospital
Shanghai, Shanghai 200123
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 ofSite Not Available
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi 03722
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi 03080
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
Seoul National University Bundang Hospital
Seongnam-si, 13620
Korea, Republic ofSite Not Available
Usc Norris Comprehensive Cancer Center (Nccc)
Los Angeles, California 90089-1019
United StatesActive - Recruiting
Yale Cancer Center
New Haven, Connecticut 06520-8028
United StatesActive - Recruiting
Mayo Clinic Rochester
Rochester, Minnesota 55905-0001
United StatesActive - Recruiting
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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