Study of IBI323 in Patients With Advanced Malignancies

NCT04916119 | Unknown Phase 1

• 1 other identifier: CIBI323A101
• Study Type: interventional
• Target: 322
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Malignancies

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Investigator Assessments of Overall Response Rate(ORR)

  24 months

• Disease Control Rate(DCR)

  24 months

• PFS (progression-free survival)

  24 months

• Anti-drug antibody (ADA)

  24 months

Study Arms (1)

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

Drug: IBI323

Interventions

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

IBI323

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Shang Hai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Central Study Contacts

yu Wang

CONTACT

0512-69566088; yu.wang01@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 7, 2021
• Study Start: June 29, 2021
• Primary Completion: June 23, 2023
• Study Completion: December 9, 2023
• Last Updated: September 16, 2022

Record last verified: 2022-09

Locations

CN (1)