Phase
Condition
Solid Tumors
Treatment
BG-C0902
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants with histologically or cytologically confirmed advanced, metastatic, orunresectable solid tumors not amenable to therapy with curative intent or for whomtreatment is not available or not tolerated.
Participants must be able to provide archival tissue formalin-fixedparaffin-embedded (FFPE) block containing tumor tissue or approximately 10 to 15freshly cut unstained FFPE slides) or recently obtained fresh tumor biopsy samplesat screening.
Participants must have ≥ 1 measurable lesion as assessed by RECIST v1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1, as assessed ≤ 14days before the first dose of study drug.
Adequate bone marrow and organ function as indicated by the following laboratoryvalues ≤ 14 days before the first dose of study drug
Female participants of childbearing potential must be willing to use a highlyeffective method of birth control for the duration of the study and for ≥ 7 monthsafter the last dose of study drug. They must also have a negative serum pregnancytest result ≤ 3 days before the first dose of study drug.
Nonsterile male participants must be willing to use a highly effective method ofbirth control and refrain from sperm donation for the duration of the study and for ≥ 4 months after the last dose of study drug.
Exclusion
Exclusion Criteria:
History of severe allergic reactions or hypersensitivity to BG-T187 or othermonoclonal antibodies, or to the active ingredient and excipients of the study drugor camptothecins.
For Phase 1a Part B Safety Expansion and Phase 1b only: Prior treatment with anEGFR-targeting ADC or mesenchymal-epithelial transition (MET)-targetingantibody-drug conjugate (ADC), or any ADC with topoisomerase I (TOPO1) inhibitorpayload.
Active leptomeningeal disease or uncontrolled, untreated brain metastasis.Participants with a history of treated and, at the time of screening, stable centralnervous system (CNS) metastases are eligible, provided they meet all the following:
Brain imaging at screening shows no evidence of interim progression, isclinically stable for ≥ 4 weeks, and has no evidence of new brain metastases
Have measurable disease and/or evaluable disease outside CNS
No ongoing requirement for corticosteroids as therapy for CNS disease; offcorticosteroids ≥ 14 days before dosing with study drug; anticonvulsants at astable dose are allowed
No stereotactic radiation or whole-brain radiation ≤ 14 days before the firstdose of study drug
History of interstitial lung disease (ILD), or ≥ Grade 2 noninfectious pneumonitis ≤ 2 years before the first dose of the study drug, or has current ILD/noninfectiouspneumonitis, or where suspected active ILD/noninfectious pneumonitis cannot be ruledout by imaging during screening.
Participants with active or chronic corneal disorder, including but not limited toSjögren's, Fuch's corneal dystrophy, 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.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Blacktown Cancer and Haematology Centre
Blacktown 2175411, New South Wales 2155400 NSW 2148
AustraliaActive - Recruiting
The Alfred Hospital
Melbourne 2158177, Victoria 2145234 VIC 3004
AustraliaActive - Recruiting
Zhejiang Cancer Hospital
Hangzhou 1808926, Zhejiang 1784764 310022
ChinaActive - Recruiting
Next Oncology
Austin 4671654, Texas 4736286 78758
United StatesActive - Recruiting

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