Brief Summary
The primary objective of this study to evaluate the safety and tolerability of IBI334 and determine the maximum tolerated dosethe amount of medication taken (MTD) and the recommended Phase 2 Dose (RP2D) of IBI334.
Intervention / Treatment
- Drug: IBI334 D
- Drug: IBI334 C
- Drug: IBI334 A
- Drug: IBI334 B
- Drug: IBI334 F
- Drug: IBI334 E
Inclusion Criteria：
- Male or female subjects ≥ 18 years old;
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status (PS) of 0 or 1;
- Anticipated life expectancy of ≥ 12 weeks;
- Adequate bone marrowsoft, spongy tissue found in bones that makes blood cells and organ function;Criteria for dose escalation phase only:
- Has a documented (histologically- or cytologically-proven), unresectable, locally advancedat a late stage, far along or metastatic solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available (mainly focused on non-small-cell lung cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs, head and neck squamous cell carcinomacancer arising from tissues that line organs and RAS-wildtype colorectalrelating to the colon or rectum in the large bowel/intestine cancer);
- At least 1 evaluable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;Criteria for dose expansion phase only:
- Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic non-small-cell lung cancer, head and neck squamous cell carcinoma or RAS-wildtype colorectal cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available;
- At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.