Trial NCT07414836
A First-in-Human Study of BG-C0979 in Adults With Advanced Solid Tumors
- Phase
- Phase 1
- Sponsor
- BeOne Medicines
- Conditions
- Advanced Solid Tumor
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Inclusion Criteria:
* Phase 1a (Monotherapy Dose Escalation and Safety Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available or not tolerated, or determined not appropriate based on investigator's judgment.
* Phase 1b Part A (Monotherapy Dose Optimization and Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available or not tolerated, or determined not appropriate based on investigator's judgment.
* Phase 1b Part B (Combination Therapy Expansion): Participants with histologically or cytologically confirmed metastatic or unresectable advanced solid tumors who have not received any prior systemic treatment for advanced or metastatic disease.
* Participants must have ≥ 1 measurable lesion as assessed by RECIST v1.1.
* Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Participants must have adequate organ function.
Exclusion Criteria:
* Prior treatment with any ADAM9 (a disintegrin and metalloproteinase domain 9)-targeted antibody-drug conjugates (ADCs) or ADCs containing TOPO1 (DNA topoisomerase 1) inhibitor as payload.
* Active leptomeningeal disease or uncontrolled, untreated brain metastasis.Brain metastases
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Restrictions found (1)
- Brain metastasesConditionalexclusionShow in the text
Recruiting in Massachusetts
- Dana Farber Cancer Institute · Boston, Suffolk County