Status:
COMPLETED
IBI322 Monotherapy or Combination Therapy in Subjects With Advanced Malignant Tumors.
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The Phase Ia study was designed to evaluate the tolerability, safety, PK, PD, immunogenicity and primary resistance of single therapy tumor activity in subjects with advanced or metastatic solid tumor...
Eligibility Criteria
Inclusion
- Histologically/cytologically confirmed, locally advanced unresectable or metastatic tumors.
- Per RECIST1, at least one evaluable or measurable lesion.
- Male or female subject above 18 years old, no more than 75 years old.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 or 1.
- Must have adequate organ function
Exclusion
- Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein.
- Direct coombs test was positive or have history of hemolytic anemia.
- Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies.
- 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.)
- Subjects who have a history of blood transfusion within 2 weeks prior to the study.
Key Trial Info
Start Date :
July 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 25 2023
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT04912466
Start Date
July 21 2021
End Date
August 25 2023
Last Update
September 6 2023
Active Locations (1)
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1
Shandong Province Cancer Hospital
Jinan, Shandong, China, 250117