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The purpose of this study is to evaluate safety, tolerability and efficacy of IBI323(anti-LAG-3/PD-L1) or in combination with chemotherapy in participants with advanced malignancies. Another purpose is to determine the pharmacokinetics,pharmacodynamics and immunogenicity of IBI323
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI323 | Experimental | Phase Ia enrolls patients with advanced malignancies. Phase Ib cohort A enrolls patients with NSCLC(IO-refractory), cohort B NSCLC(IO-naive), cohort C NSCLC(PD-L1 TPS≥1%), cohort D ES-SCLC or neuroendocrine tumors, cohort E MPM, cohort F UC, cohort G nccRCC, cohort H HCC, cohort I NPC, cohort J CC or HNSCC, cohort K GC or GEJC with HER2 negative, cohort L TNBC |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI323 | Drug | In phase Ia study, seven dose levels of IBI323 (0.03, 0.1, 0.3, 1, 3, 10 and 20mg/kg) will be evaluated. The DLT observation period is 28 days. IBI323 is administered by iv infusion day 1 of every 14 days. After dose escalation stage completed, two dose levels (10mg/kg and 20mg/kg) will be expanded to 20 patients each. In Phase Ib study, IBI323 is administered RP2D by iv infusion day 1 of every 14 days. IBI323 and chemotherapy will be administrated in cohort C and cohort K |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | To evaluate the safety and tolerability of IBI323 [Adverse events (AEs), treatment-related AE (TRAE), immune-related AEs (irAE), serious adverse event (SAE), dose-limiting toxicity (DLT) assessed by CTCAE v5.0] | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Assessments of Overall Response Rate(ORR) | RECIST v1.1 will be used to determine ORR by investigator | 24 months |
| Disease Control Rate(DCR) | RECIST v1.1 will be used to determine DCR by investigator |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yu Wang | Contact | 0512-69566088 | yu.wang01@innoventbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shang Hai Pulmonary Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
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| 24 months |
| PFS (progression-free survival) | RECIST v1.1 will be used to determine PFS by investigator | 24 months |
| Anti-drug antibody (ADA) | 24 months |