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

Advanced Malignancies Clinical Trial

Official title:

A Phase 1a/1b Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Advanced Malignant Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04328831
• Other study ID #: CIBI322A101
• Status: Completed
• Phase: Phase 1
• Start date: July 31, 2020
• Est. completion date: August 28, 2023

Study information

• Verified date: October 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: August 28, 2023
• Est. primary completion date: August 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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, SIRPa antibody, or CD47/SIRPa 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.

Related Conditions & MeSH terms

• Advanced Malignancies
• Neoplasms

Intervention

Biological:
• IBI322
Recombinant anti-human CD47/PD-L1 bispecific antibody injection

Locations

Country	Name	City	State
China	Cancer hospital Chinese academy of Medical sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of DLT		28 days
Primary	Number of treatment related AEs		90 days post last dose
Primary	Number of patients with response		Last patient enrolled+24 weeks
Secondary	PK parameters: The area under the curve (AUC)		Up to 90 days post last dose
Secondary	PK parameters: Maximum concentration (Cmax)		Up to 90 days post last dose
Secondary	PK parameters: Time at which maximum concentration (Tmax)		Up to 90 days post last dose
Secondary	PK parameters: The half-life (t1/2)		Up to 90 days post last dose
Secondary	Positive rate of ADA and Nab		Up to 90 days post last dose
Secondary	Positive rate of Circulating Immune Complex		Up to last dose