Study of IBI323 in Patients With Advanced Malignancies
- Registration Number
- NCT04916119
- Lead Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 322
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IBI323 IBI323 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
- Primary Outcome Measures
Name Time Method 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
Name Time Method Disease Control Rate(DCR) 24 months RECIST v1.1 will be used to determine DCR by investigator
Anti-drug antibody (ADA) 24 months Investigator Assessments of Overall Response Rate(ORR) 24 months RECIST v1.1 will be used to determine ORR by investigator
PFS (progression-free survival) 24 months RECIST v1.1 will be used to determine PFS by investigator
Trial Locations
- Locations (1)
Shang Hai Pulmonary Hospital
🇨🇳Shanghai, Shanghai, China