Advanced Malignancies
Conditions
Keywords
Oncology
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.
Interventions
BIOLOGICALIBI322
Recombinant anti-human CD47/PD-L1 bispecific antibody injection
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of DLT | 28 days |
| Number of treatment related AEs | 90 days post last dose |
| Number of patients with response | Last patient enrolled+24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters: Maximum concentration (Cmax) | Up to 90 days post last dose |
| Positive rate of ADA and Nab | Up to 90 days post last dose |
| PK parameters: The half-life (t1/2) | Up to 90 days post last dose |
| PK parameters: Time at which maximum concentration (Tmax) | Up to 90 days post last dose |
| Positive rate of Circulating Immune Complex | Up to last dose |
| PK parameters: The area under the curve (AUC) | Up to 90 days post last dose |
Countries
China
Outcome results
None listed