Status:
UNKNOWN
Study of IBI323 in Patients With Advanced Malignancies
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Advanced Malignancies
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 i...
Eligibility Criteria
Inclusion
- 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
- Able to understand and willing to sign the ICF.
- 18 to 75 years old.
- Life expectancy at least 12 weeks.
- At least 1 measurable lesion per RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ and bone marrow functionAdequate organ and bone marrow function.
Exclusion
- Prior treatment with any anti- LAG-3 antibody.
- Prior immunotherapy treatment for Stage Ia extension cohort ( immunotherapy untreated) and Stage Ib cohort B-L
- Any investigational drugs received within 4 weeks prior to the first study treatment.
- Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy.
- Symptomatic CNS metastasis.
- History of autoimmune disease , present active autoimmune disease or inflammatory diseases
- Pregnant or nursing females.
Key Trial Info
Start Date :
June 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 9 2023
Estimated Enrollment :
322 Patients enrolled
Trial Details
Trial ID
NCT04916119
Start Date
June 29 2021
End Date
December 9 2023
Last Update
September 16 2022
Active Locations (1)
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1
Shang Hai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433