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

Primary Purpose

Hematologic Malignancy

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
IBI322
Sponsored by
Innovent Biologics (Suzhou) Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematologic Malignancy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, SIRPα antibody, or CD47/SIRPα 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

Sites / Locations

  • The Second Affiliated Hospital Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

IBI322

Arm Description

Single arm

Outcomes

Primary Outcome Measures

Number of treatment related AEs
Safety
Number of patients with response
Preliminary Efficacy

Secondary Outcome Measures

PK Parameters: The area under the curve (AUC)
Safety and Preliminary Efficacy
PK Parameters: Maximum concentration (Cmax)
Safety and Preliminary Efficacy
PK Parameters: Half-life (t1/2)
Safety and Preliminary Efficacy
PK Parameters: Clearance (CL)
Safety and Preliminary Efficacy
PK Parameters: Volume of Distribution (V)
Safety and Preliminary Efficacy
Positive Rate of ADA and Nab
Safety and Preliminary Efficacy

Full Information

First Posted
February 26, 2021
Last Updated
September 12, 2022
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04795128
Brief Title
A Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Hematologic Malignancy
Official Title
A Phase I Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Hematologic Malignancy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 7, 2021 (Actual)
Primary Completion Date
October 28, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IBI322
Arm Type
Other
Arm Description
Single arm
Intervention Type
Biological
Intervention Name(s)
IBI322
Intervention Description
Recombinant anti-human CD47/PD-L1 bispecific antibody injection
Primary Outcome Measure Information:
Title
Number of treatment related AEs
Description
Safety
Time Frame
Up to 90 days post last dose
Title
Number of patients with response
Description
Preliminary Efficacy
Time Frame
Last patient enrolled +24 weeks
Secondary Outcome Measure Information:
Title
PK Parameters: The area under the curve (AUC)
Description
Safety and Preliminary Efficacy
Time Frame
Up to 90 days post last dose
Title
PK Parameters: Maximum concentration (Cmax)
Description
Safety and Preliminary Efficacy
Time Frame
Up to 90 days post last dose
Title
PK Parameters: Half-life (t1/2)
Description
Safety and Preliminary Efficacy
Time Frame
Up to 90 days post last dose
Title
PK Parameters: Clearance (CL)
Description
Safety and Preliminary Efficacy
Time Frame
Up to 90 days post last dose
Title
PK Parameters: Volume of Distribution (V)
Description
Safety and Preliminary Efficacy
Time Frame
Up to 90 days post last dose
Title
Positive Rate of ADA and Nab
Description
Safety and Preliminary Efficacy
Time Frame
Up to 90 days post last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically/cytologically confirmed hematologic malignancy who failed the standard treatment At least one evaluable lesion Male or female 18 to 75 years old Eastern Cooperative Oncology Group Performance Status Performance Status (ECOG PS) 0-2 Must have adequate organ function Exclusion Criteria: Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein Previous exposure to chimeric antigen receptor T cell immunotherapy (CAR-T) Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies Use of anticoagulants and/or aspirin, or other non-steroidal anti-inflammatory drugs within 2 weeks prior to study start A history of blood transfusion within 2 weeks prior to study start
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Luo
Phone
0512-69566088
Email
min.luo@innoventbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
WenBin Qian
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
WenBin Qian
Phone
86-0571-89713674
Email
qianwenb@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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