Trials / Completed
CompletedNCT04328831
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 94 (actual)
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | IBI322 | Recombinant anti-human CD47/PD-L1 bispecific antibody injection |
Timeline
- Start date
- 2020-07-31
- Primary completion
- 2023-08-28
- Completion
- 2023-08-28
- First posted
- 2020-03-31
- Last updated
- 2023-10-10
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04328831. Inclusion in this directory is not an endorsement.