Safety and Efficacy of IBI322 in Chinese Subjects With Advanced Malignant Tumors

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04328831
• Collaborator: (none)
• Enrollment: 218
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 40
• Patients Per Site Per Month: 5.4

Study Details

Study Description

Brief Summary

This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in cancer subjects who failed standard treatment.

Condition or Disease	Intervention/Treatment	Phase
Advanced Malignancies	Biological: IBI322	Phase 1

Detailed Description

Phase 1a/Ib study will be conducted to evaluate the tolerability, safety, PK, PD, immunogenicity and preliminary antitumor activity of IBI322 in China. Phase 1a is dose escalation and plans to enroll approximately 38-60 subjects with advanced malignant solid tumors who failed the standard treatment. Phase Ib is dose expansion, and plans to enroll approximately 180 subjects with advanced malignant tumors.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 218 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1a/1b Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Advanced Malignant Tumors
• Actual Study Start Date: Jul 31, 2020
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: IBI322 Single arm	Biological: IBI322; Recombinant anti-human CD47/PD-L1 bispecific antibody injection

Outcome Measures

Primary Outcome Measures

1. Number of DLT [28 days]

2. Number of treatment related AEs [90 days post last dose]

3. Number of patients with response [Last patient enrolled+24 weeks]

Secondary Outcome Measures

1. PK parameters: The area under the curve (AUC) [Up to 90 days post last dose]

2. PK parameters: Maximum concentration (Cmax) [Up to 90 days post last dose]

3. PK parameters: Time at which maximum concentration (Tmax) [Up to 90 days post last dose]

4. PK parameters: The half-life (t1/2) [Up to 90 days post last dose]

5. Positive rate of ADA and Nab [Up to 90 days post last dose]

6. Positive rate of Circulating Immune Complex [Up to last dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Histologically/cytologically confirmed, locally advanced unresectable or metastatic tumors.

2. At least one evaluable lesion.

3. Male or female subject above 18 years old, no more than 75 years old.

4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 or 1.

5. Must have adequate organ function

Exclusion Criteria:

1. Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein.

2. Previous exposure to any anti-programmed death receptor 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) /anti-programmed death ligand 2 (PD-L2) antibodies

3. Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies.

4. Patients who are on anticoagulants and /or require concomitant aspirin or other nonsteroids anti-inflammatory medications. Patients with a history of a bleeding diathesis (von Willebrand disease, end stage liver disease, hemophilia, etc.)

5. Subjects who have a history of blood transfusion within 2 weeks prior to the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer hospital Chinese academy of Medical sciences	Beijing		China

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: NCT04328831
• Other Study ID Numbers: CIBI322A101
• First Posted: Mar 31, 2020
• Last Update Posted: Aug 13, 2020
• Last Verified: Aug 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Innovent Biologics (Suzhou) Co. Ltd.: Oncology
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Aug 13, 2020