Study of IBI323 in Patients With Advanced Malignancies
Study Details
Study Description
Brief Summary
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
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: IBI323 Phase Ia enrolls in patients with advanced malignancies. Phase Ib cohort A enrolls in 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 |
Drug: IBI323
In phase Ia study, seven dose levels of IBI323 (0.03, 0.1, 0.3, 1, 3, 10 and 20mg/kg) will be tested. 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
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Outcome Measures
Primary Outcome Measures
- Incidence of Adverse Events (AEs) [24 months]
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]
Secondary Outcome Measures
- Investigator Assessments of Overall Response Rate(ORR) [24 months]
RECIST v1.1 will be used to determine ORR by investigator
- Disease Control Rate(DCR) [24 months]
RECIST v1.1 will be used to determine DCR by investigator
- PFS (progression-free survival) [24 months]
RECIST v1.1 will be used to determine PFS by investigator
- Anti-drug antibody (ADA) [24 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Phase Ia Patients with locally advanced, recurrent or metastatic solid tumors who have failed standard treatment Phase Ib cohort A Patients with IO-refractory advanced NSCLC cohort B Patients with IO-naive advanced NSCLC who have failed standard treatment cohort C Patients with advanced NSCLC who have no prior treatment and PD-L1 TPS≥1% cohort D Patients with ES-SCLC or G3 neuroendocrine tumors who have failed standard treatment cohort E Patients with advanced MPM who have failed standard treatment cohort F Patients with advanced UC who have failed standard treatment cohort G Patients with advanced nccRCC who have failed standard treatment cohort H Patients with advanced HCC who have failed standard treatment cohort I Patients with advanced NPC who have failed standard treatment cohort J Patients with advanced CC or HNSCC who have failed standard treatment cohort K Patients with advanced GC or GEJC with HER2 negative who have no prior treatment cohort L Patients with advanced TNBC who have failed standard treatment
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Able to understand and willing to sign the ICF.
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18 to 75 years old.
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Life expectancy at least 12 weeks.
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At least 1 measurable lesion per RECIST v1.1.
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Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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Adequate organ and bone marrow functionAdequate organ and bone marrow function.
Exclusion Criteria:
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Prior treatment with any anti- LAG-3 antibody.
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Prior immunotherapy treatment for Stage Ia extension cohort ( immunotherapy untreated) and Stage Ib cohort B-L
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Any investigational drugs received within 4 weeks prior to the first study treatment.
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Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy.
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Symptomatic CNS metastasis.
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History of autoimmune disease , present active autoimmune disease or inflammatory diseases
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Pregnant or nursing females.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Shang Hai Pulmonary Hospital | Shanghai | Shanghai | China | 200433 |
Sponsors and Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIBI323A101