IBI334 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2026-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Criteria

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.