IBI322 Recombinant anti-human CD47/PD-L1 bispecific antibody injection for Advanced Cancers

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Advanced Cancers+1 MoreIBI322 Recombinant anti-human CD47/PD-L1 bispecific antibody injection - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer drug to see if it is safe and works better than current treatments.

Eligible Conditions
  • Advanced Cancers
  • Advanced Malignant Lymphomas

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

4 Primary · 7 Secondary · Reporting Duration: Through study completion, an average of 1 year

Day 21
Dose Limiting Toxicity (DLT)
28 days
Number of DLT time
Day 90
Number of treatment related AEs
Day 90
Treatment-related Adverse Events (TRAEs)
Year 1
Positive rate of Circulating Immune Complex
Day 90
PK parameters
PK parameters: Maximum concentration (Cmax)
PK parameters: The area under the curve (AUC)
PK parameters: The half-life (t1/2)
PK parameters: Time at which maximum concentration (Tmax)
Positive rate of ADA and Nab

Trial Safety

Safety Progress

1 of 3

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Trial Design

1 Treatment Group

Dose Escalation of IBI322
1 of 1

Experimental Treatment

51 Total Participants · 1 Treatment Group

Primary Treatment: IBI322 Recombinant anti-human CD47/PD-L1 bispecific antibody injection · No Placebo Group · Phase 1

Dose Escalation of IBI322
Biological
Experimental Group · 1 Intervention: IBI322 Recombinant anti-human CD47/PD-L1 bispecific antibody injection · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 1 year

Who is running the clinical trial?

Innovent Biologics (Suzhou) Co. Ltd.Lead Sponsor
133 Previous Clinical Trials
21,989 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a performance status of 0 or 1.
You are a male or female > 18 years old.
Female subjects of childbearing age or male subjects whose partners are women at childbearing age, need to use 2 highly effective contraceptive measures, including one barrier method, throughout the treatment period and 6 months after the treatment period.
You are willing to sign an informed consent form and be able to comply with the study's rules and visits/related procedures.