Trials / Completed
CompletedNCT04912466
IBI322 Monotherapy or Combination Therapy in Subjects With Advanced Malignant Tumors.
A Phase 1a/1b Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 Monotherapy or Combination Therapy in Subjects With Advanced Malignant Tumors.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 61 (actual)
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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 tumors who have failed standard treatment. Phase Ib study was designed to evaluate the safety and initial efficacy of IBI322 in monotherapy or combination therapy in subjects with advanced or metastatic solid tumors. Investigators and sponsors determine the recommended dose of IBI322 for phase Ib based on PK, PD, safety and efficacy data obtained during phase Ia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Biological: IBI322 | Recombinant anti-human CD47/PD-L1 bispecific antibody injection |
Timeline
- Start date
- 2021-07-21
- Primary completion
- 2022-12-03
- Completion
- 2023-08-25
- First posted
- 2021-06-03
- Last updated
- 2023-09-06
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04912466. Inclusion in this directory is not an endorsement.