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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.

Tracking Information
First Submitted Date  ICMJE June 1, 2021
First Posted Date  ICMJE June 7, 2021
Last Update Posted Date September 9, 2021
Actual Study Start Date  ICMJE June 29, 2021
Estimated Primary Completion Date June 23, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2021)
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]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2021)
  • Investigator Assessments of Overall Response Rate(ORR) [ Time Frame: 24 months ]
    RECIST v1.1 will be used to determine ORR by investigator
  • Disease Control Rate(DCR) [ Time Frame: 24 months ]
    RECIST v1.1 will be used to determine DCR by investigator
  • PFS (progression-free survival) [ Time Frame: 24 months ]
    RECIST v1.1 will be used to determine PFS by investigator
  • Anti-drug antibody (ADA) [ Time Frame: 24 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of IBI323 in Patients With Advanced Malignancies
Official Title  ICMJE A Phase I, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of IBI323 in Participants With Advanced Malignancies
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Malignancies
Intervention  ICMJE 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
Study Arms  ICMJE 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
Intervention: Drug: IBI323
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 1, 2021)
322
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 9, 2023
Estimated Primary Completion Date June 23, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: yu Wang 0512-69566088 yu.wang01@innoventbio.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04916119
Other Study ID Numbers  ICMJE CIBI323A101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Innovent Biologics (Suzhou) Co. Ltd.
Study Sponsor  ICMJE Innovent Biologics (Suzhou) Co. Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Innovent Biologics (Suzhou) Co. Ltd.
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP