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Study of IBI323 in Patients With Advanced Malignancies

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ClinicalTrials.gov Identifier: NCT04916119
Recruitment Status : Recruiting
First Posted : June 7, 2021
Last Update Posted : September 9, 2021
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Advanced Malignancies Drug: IBI323 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 322 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of IBI323 in Participants With Advanced Malignancies
Actual Study Start Date : June 29, 2021
Estimated Primary Completion Date : June 23, 2022
Estimated Study Completion Date : March 9, 2023

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: 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 :
  1. Investigator Assessments of Overall Response Rate(ORR) [ Time Frame: 24 months ]
    RECIST v1.1 will be used to determine ORR by investigator

  2. Disease Control Rate(DCR) [ Time Frame: 24 months ]
    RECIST v1.1 will be used to determine DCR by investigator

  3. PFS (progression-free survival) [ Time Frame: 24 months ]
    RECIST v1.1 will be used to determine PFS by investigator

  4. Anti-drug antibody (ADA) [ Time Frame: 24 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Able to understand and willing to sign the ICF.
  3. 18 to 75 years old.
  4. Life expectancy at least 12 weeks.
  5. At least 1 measurable lesion per RECIST v1.1.
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  7. Adequate organ and bone marrow functionAdequate organ and bone marrow function.

Exclusion Criteria:

  1. Prior treatment with any anti- LAG-3 antibody.
  2. Prior immunotherapy treatment for Stage Ia extension cohort ( immunotherapy untreated) and Stage Ib cohort B-L
  3. Any investigational drugs received within 4 weeks prior to the first study treatment.
  4. Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy.
  5. Symptomatic CNS metastasis.
  6. History of autoimmune disease , present active autoimmune disease or inflammatory diseases
  7. Pregnant or nursing females.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04916119


Contacts
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Contact: yu Wang 0512-69566088 yu.wang01@innoventbio.com

Locations
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China, Shanghai
Shang Hai Pulmonary Hospital Recruiting
Shanghai, Shanghai, China, 200433
Contact: Cai cun Zhou    021-65115006    caicunzhoudr@163.com   
Sponsors and Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
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Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier: NCT04916119    
Other Study ID Numbers: CIBI323A101
First Posted: June 7, 2021    Key Record Dates
Last Update Posted: September 9, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms