Clinical trial NCT04795128: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hematologic Malignancy
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2021-03-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of treatment related AEs
timeFrame: Up to 90 days post last dose
measure: Number of patients with response
timeFrame: Last patient enrolled +24 weeks
Secondary outcomes:
measure: PK Parameters: The area under the curve (AUC)
timeFrame: Up to 90 days post last dose
measure: PK Parameters: Maximum concentration (Cmax)
timeFrame: Up to 90 days post last dose
measure: PK Parameters: Half-life (t1/2)
timeFrame: Up to 90 days post last dose
measure: PK Parameters: Clearance (CL)
timeFrame: Up to 90 days post last dose
measure: PK Parameters: Volume of Distribution (V)
timeFrame: Up to 90 days post last dose
measure: Positive Rate of ADA and Nab
timeFrame: Up to 90 days post last dose
Other outcomes:
Locations:
city: Zhejiang
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: WenBin Qian
role: PRINCIPAL_INVESTIGATOR
References: