Brief Summary
The primary objective of this study to evaluate the safety and tolerability of IBI334 and determine the maximum tolerated dose (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 Oncology 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 cancer, head and neck squamous cell carcinomacancer arising from tissues that line organs and RAS-wildtype colorectal 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.