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NCT07896460
A First-in-Human Study of BG-92505 Alone or in Combination With Other Anti-cancer Agents in Patients With Advanced Solid Tumors
Conditions: Advanced Solid Tumor
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 137
Sponsor: BeOne Medicines
Summary
The purpose of this study is to test if the BG-92505 is safe and if it works in patients with advanced solid tumors when it is given on its own or in combination with anti-cancer agents.
Eligibility Criteria
Inclusion Criteria:
Participants are eligible to be included in the study only if they meet all the following criteria:
1. (i) Part A1 (Mono Dose Escalation): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), head and neck squamous cell carcinoma (HNSCC), or hepatocellular carcinoma (HCC) who have documented disease progression on prior available standard systemic therapy or for whom treatment is not available or not tolerated or determined not appropriate based on investigator's judgment.
(ii) Part A2 (Mono Safety Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable squamous NSCLC, ESCC, or HNSCC who have documented disease progression on prior available standard systemic therapy or for whom treatment is not available or not tolerated or determined not appropriate based on investigator's judgment.
(iii) Part B (Combo Dose Escalation): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable squamous NSCLC, ESCC, or HNSCC whose disease has progressed on prior standard systemic therapy.
2. Must have ≥ 1 measurable lesion as assessed by RECIST v1.1.
3. Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Exclusion Criteria:
Participants are excluded from the study if they meet any of the following criteria:
1. Prior treatment with any KEAP1 activator and the ant-cancer agent (only for Part B).
2. Participants who have a history of severe allergic reactions or hypersensitivity to the active ingredients and excipients of study drug.
3. Participants who are unable to comply with the requirements of the protocol, unless the written approval of the medical monitor has been obtained before informed consent.
4. Participants who are known to have a mutation that has no expectation of benefit from BG-92505.
Note: Other protocol defined inclusion/exclusion criteria may apply.
Source: ClinicalTrials.gov (NCT07896460). StuddyBuddy aggregates publicly available trial information.