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

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05774873
• Collaborator: (none)
• Enrollment: 128
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 35
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumors	Drug: IBI334	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 128 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1 Study of IBI334 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
• Anticipated Study Start Date: Jul 31, 2023
• Anticipated Primary Completion Date: Oct 31, 2025
• Anticipated Study Completion Date: Jun 30, 2026

Arms and Interventions

Arm

Intervention/Treatment

Experimental: IBI334

Drug: IBI334; Subjects will receive IBI334 once a week during the first 28-day cycle (QW, 4 weeks), then biweekly (or other dose intervals recommended by the Investigator and Sponsor based on safety, toxicity and PK data), until disease progression, toxicity intolerance, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or treatment duration reaches 24 months, whichever occurs first.

Outcome Measures

Primary Outcome Measures

1. Number of patients with treatment-related adverse events [Up to 60 days post last dose]

   Number of patients who experenced a treatment realted AEs from the first dose until 60 days after the last dose

2. Percentage of subjects woth Dose-Limitine toxicities(DLTs) [Up to 28 days following first dose]

   To evaluate the safety and tolerability of IBI334

Secondary Outcome Measures

1. Objective Response Rate (ORR) [Up to 60 days post last dose]

   Objective Response Rate (ORR) is the percentage of Complete Response (CR) plus partial response(PR) assessed per RECIST v1.1 criteria .

2. Duration of response (DoR) [Up to 60 days post last dose]

   For subjects with CR or PR, duration of response(DoR) is the time from the first documented CR or PR to diserse progression or death assessed per RECIST V1.1 criteria.

3. Disease control rate (DCR) [Up to 60 days post last dose]

   Disease control rate (DCR) is the percentage of CR plus PR Plus stable diserse (SD) assessed per RECIST v1.1 criteria.

4. Time to Response (TTR) [Up to 60 days post last dose]

   For subjects with CR or PR, time to response(TTR) is the time from first dose of study drugs to the first documented CR or PR assessed per RECIST v1.1 criteria.

5. Progression-free survival (PFS) [Up to 60 days post last dose]

   Time from randomization to first documented diserse progression (radiographic) assessed by investigator per RECIST v1.1 criteria or death due to any cause.

6. Overall survival (OS) [Up to 60 days post last dose]

   Time from randomization to death of the subject due to any cause.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

1. 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);

2. At least 1 evaluable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;

Criteria for dose expansion phase only:

1. 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;

2. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Westmead Hospital	Waratah	New South Wales	Australia	2145

Sponsors and Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
• ClinicalTrials.gov Identifier: NCT05774873
• Other Study ID Numbers: CIBI334A101
• First Posted: Mar 20, 2023
• Last Update Posted: Mar 20, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Mar 20, 2023