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

Innovent Biologics

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Solid Tumors

Treatments: Drug: IBI334 C; Drug: IBI334 D; Drug: IBI334 A; Drug: IBI334 F; Drug: IBI334 E; Drug: IBI334 B

Study type: Interventional

Funder types: Industry

Identifiers

NCT05774873

CIBI334A101

Details and patient eligibility

About

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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128 participants in 6 patient groups

IBI334 E

Experimental group

Treatment:

Drug: IBI334 E

IBI334 D

Experimental group

Treatment:

Drug: IBI334 D

IBI334 C

Experimental group

Treatment:

Drug: IBI334 C

IBI334 A

Experimental group

Treatment:

Drug: IBI334 A

IBI334 F

Experimental group

Treatment:

Drug: IBI334 F

IBI334 B

Experimental group

Treatment:

Drug: IBI334 B