Safety and Efficacy of IBI322 in Chinese Subjects With Advanced Malignant Tumors
A Phase 1a/1b Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Advanced Malignant Tumors
1 other identifier
interventional
94
1 country
1
Brief Summary
This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in cancer subjects who failed standard treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2020
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2020
CompletedFirst Posted
Study publicly available on registry
March 31, 2020
CompletedStudy Start
First participant enrolled
July 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2023
CompletedOctober 10, 2023
October 1, 2023
3.1 years
March 24, 2020
October 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (6)
PK parameters: The area under the curve (AUC)
Up to 90 days post last dose
PK parameters: Maximum concentration (Cmax)
Up to 90 days post last dose
PK parameters: Time at which maximum concentration (Tmax)
Up to 90 days post last dose
PK parameters: The half-life (t1/2)
Up to 90 days post last dose
Positive rate of ADA and Nab
Up to 90 days post last dose
- +1 more secondary outcomes
Study Arms (1)
IBI322
OTHERSingle arm
Interventions
Eligibility Criteria
You may qualify if:
- Histologically/cytologically confirmed, locally advanced unresectable or metastatic tumors.
- At least one evaluable 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
You may not qualify if:
- Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein.
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cancer hospital Chinese academy of Medical sciences
Beijing, China
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2020
First Posted
March 31, 2020
Study Start
July 31, 2020
Primary Completion
August 28, 2023
Study Completion
August 28, 2023
Last Updated
October 10, 2023
Record last verified: 2023-10