Clinical trial NCT04328831: Safety and Efficacy of IBI322 in Chinese Subjects With Advanced Malignant Tumors
Official title: A Phase 1a/1b Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Advanced Malignant Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Malignancies
Keywords: Oncology
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-03-31
Enrollment: 94
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 cancer subjects who failed standard treatment.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of DLT
timeFrame: 28 days
measure: Number of treatment related AEs
timeFrame: 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: Time at which maximum concentration (Tmax)
timeFrame: Up to 90 days post last dose
measure: PK parameters: The half-life (t1/2)
timeFrame: Up to 90 days post last dose
measure: Positive rate of ADA and Nab
timeFrame: Up to 90 days post last dose
measure: Positive rate of Circulating Immune Complex
timeFrame: Up to last dose
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer hospital Chinese academy of Medical sciences
Study officials:
References: