Overview

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.

Eligibility

Inclusion Criteria：

1. Male or female subjects ≥ 18 years old;
2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
3. Anticipated life expectancy of ≥ 12 weeks;
4. Adequate bone marrow and organ function;

   Criteria for dose escalation phase only:

5. Has a documented (histologically- or cytologically-proven), unresectable, locally advanced 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 carcinoma and RAS-wildtype colorectal cancer);
6. At least 1 evaluable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;

   Criteria for dose expansion phase only:

7. 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;
8. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Exclusion Criteria：

1. Participate in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of the interventional study;
2. Received live vaccines within 4 weeks prior to first dose of the study drug or plan on receiving any live vaccine during the study;
3. Received total pelvic radiotherapy;
4. Pyloric obstruction and/or persistent recurrent vomiting (≥ 3 times in 24 hours);
5. Uncontrolled diseases;
6. History of endotracheal or gastrointestinal stent implantation;
7. Multiple concurrent malignant tumors within 5 years (except non-melanoma skin cancer, carcinoma in situ or non-invasive tumor that were cured);
8. Women who are pregnant, have positive results in pregnancy test or are lactating;
9. Not eligible to participate in this study at the discretion of the investigator.