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A Study of BG-C477 in Participants With Advanced Solid Tumors

RecruitingPhase 1Ages 18 Years - anyAllBeOne Medicines
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-C477 alone and in combination with anticancer agents in participants with selected advanced solid tumors.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Participants must sign the informed consent form (ICF) and be capable of giving written informed consent * Participants must consent to provide an archival tumor tissue sample or a fresh baseline biopsy * Phase 1a (Dose Escalation): Histologically confirmed advanced, metastatic, or unresectable solid tumors, that were previously treated with at least 2 lines of standard systemic therapy or for whom no standard treatment is available in the medical judgment of the investigator * Phase 1b (Dose Expansion) Part A: Histologically confirmed advanced or metastatic select solid tumors that were previously treated with and progressed from at least 1 line of standard systemic therapy * Phase 1b (Dose Expansion) Part B: Histologically confirmed advanced or metastatic select solid tumors who have previously received 0 or 1 line of systemic therapy for advanced disease * โ‰ฅ 1 measurable lesion as assessed by RECIST v1.1 * Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of โ‰ค 1 * Adequate organ function * Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for โ‰ฅ 7 months after the last dose of BG-C477, for โ‰ฅ 6 months after the last dose of chemotherapy, and for โ‰ฅ 4 months after the last dose of tislelizumab,whichever comes later * Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for โ‰ฅ 4 months after the last dose of BG-C477, for โ‰ฅ 3 months after chemotherapy, whichever comes later. Exclusion Criteria: * Prior treatment with any carcinoembryonic antigen (CEA)-targeted ADCs or ADCs containing topoisomerase 1 (TOP1) inhibitor as payload * History of severe allergic reactions, severe reaction to infusion, or hypersensitivity to the active ingredient and excipients of the study drug(s) or protein-based therapeutics * Active leptomeningeal disease or uncontrolled, untreated brain metastasis * Any malignancy โ‰ค 2 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast) Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
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What it tests

  • BG-C477
  • Tislelizumab
  • Chemotherapy
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Where

59 sites
City of Hope Phoenix Cancer Center
Goodyear, United States
City of Hope National Medical Center
Duarte, United States
University of Colorado Cancer Center
Aurora, United States
Yale University Yale Cancer Center
New Haven, United States
Osf Saint Francis Medical Center
Peoria, United States
The University of Kansas Cancer Center
Westwood, United States
University of Mississippi Medical Center (Ummc)
Jackson, United States
John Theurer Cancer Center Hackensack University Medical Center
Hackensack, United States

โ€ฆand 51 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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