A Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Hematologic Malignancy

Hematologic Malignancy Clinical Trial

Official title:

A Phase I Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Hematologic Malignancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04795128
• Other study ID #: CIBI322A103
• Status: Recruiting
• Phase: Phase 1
• Start date: May 7, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: September 2022
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: Min Luo
• Phone: 0512-69566088
• Email: min.luo[@]innoventbio.com
• 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 subjects with hematologic malignancies who have failed standard treatment.

Description:

This Phase 1a/1b study will be conducted to evaluate the safety, tolerability, PK, PD, immunogenicity, and preliminary antitumor activity of IBI322 in China. Phase 1a is a dose escalation and plans to enroll approximately 39-102 subjects with hematologic malignancies who have failed standard treatments. Phase 1b is a dose expansion and plans to enroll approximately 80 subjects with hematologic malignancies.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: April 30, 2024
• Est. primary completion date: October 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Histologically/cytologically confirmed hematologic malignancy who failed the standard treatment

2. At least one evaluable lesion

3. Male or female 18 to 75 years old

4. Eastern Cooperative Oncology Group Performance Status Performance Status (ECOG PS) 0-2

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 chimeric antigen receptor T cell immunotherapy (CAR-T)

3. Subjects participating in another interventional clinical study, except for:

observational (non-interventional) clinical studies or survival follow-up phase of interventional studies

4. Use of anticoagulants and/or aspirin, or other non-steroidal anti-inflammatory drugs within 2 weeks prior to study start

5. A history of blood transfusion within 2 weeks prior to study start

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematologic Neoplasms
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Zhejiang

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 treatment related AEs	Safety	Up to 90 days post last dose
Primary	Number of patients with response	Preliminary Efficacy	Last patient enrolled +24 weeks
Secondary	PK Parameters: The area under the curve (AUC)	Safety and Preliminary Efficacy	Up to 90 days post last dose
Secondary	PK Parameters: Maximum concentration (Cmax)	Safety and Preliminary Efficacy	Up to 90 days post last dose
Secondary	PK Parameters: Half-life (t1/2)	Safety and Preliminary Efficacy	Up to 90 days post last dose
Secondary	PK Parameters: Clearance (CL)	Safety and Preliminary Efficacy	Up to 90 days post last dose
Secondary	PK Parameters: Volume of Distribution (V)	Safety and Preliminary Efficacy	Up to 90 days post last dose
Secondary	Positive Rate of ADA and Nab	Safety and Preliminary Efficacy	Up to 90 days post last dose