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Study of the Efficacy and Safety of IBI319 in Patients With Advanced Malignant Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04708210
Recruitment Status : Recruiting
First Posted : January 13, 2021
Last Update Posted : May 7, 2021
Information provided by (Responsible Party):
Innovent Biologics (Suzhou) Co. Ltd.

Tracking Information
First Submitted Date  ICMJE January 7, 2021
First Posted Date  ICMJE January 13, 2021
Last Update Posted Date May 7, 2021
Actual Study Start Date  ICMJE April 28, 2021
Estimated Primary Completion Date May 21, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2021)
Number of patients with DLT, AE, treatment-related AE (TRAE), immune-related AEs (irAE), AE of special interest (AESI), serious adverse event (SAE), discontinuation of study drug due to AE, dose-limiting toxicity (DLT) assessed by CTCAE v5.0 [ Time Frame: up to 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2021)
  • Overall response rate (ORR) based on RECIST v1.1 criteria and Lugano 2014 criteria. [ Time Frame: up to 2 years ]
  • Progression-free survival (PFS) based on RECIST v1.1 criteria and Lugano 2014 criteria [ Time Frame: up to 2 years ]
  • Overall Survival (OS) based on RECIST v1.1 criteria and Lugano 2014 criteria [ Time Frame: up to 2 years ]
  • Time To Response(TTR) based on RECIST v1.1 criteria and Lugano 2014 criteria [ Time Frame: up to 2 years ]
  • Duration of Response(DOR) based on RECIST v1.1 criteria and Lugano 2014 criteria [ Time Frame: up to 2 years ]
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 the Efficacy and Safety of IBI319 in Patients With Advanced Malignant Tumors
Official Title  ICMJE An Open-label, Multicenter, Phase Ia/Ib Study to Evaluate the Safety, Tolerance and Preliminary Efficacy of IBI319 in Patients With Advanced Malignant Tumors
Brief Summary An open-label, multicenter, phase Ia/Ib study to evaluate the safety, tolerance and preliminary efficacy of IBI319 in patients with advanced malignant tumors
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 Malignant Tumors
Intervention  ICMJE Drug: IBI319
Iv infusion day 1 of every 14 or 21 days in Phase Ia until disease progression or loss of clinical benefit.
Study Arms  ICMJE Experimental: Phase Ia Dose-Escalation Stage: IBI319
Intervention: Drug: IBI319
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 12, 2021)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 21, 2024
Estimated Primary Completion Date May 21, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
  2. Patients with advanced solid tumors or hematological malignancies who had failed standard treatment.
  3. Male or female subjects ≥18 years and ≤75 years.
  4. At least one measurable lesion (per RECIST version 1.1) in solid tumor patients and at least one measurable and hyper metabolic in 18F-FDG lesion (per Lugano2014) in lymphoma patients
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.
  6. Subjects with life expectancy of ≥ 12 weeks.
  7. Subjects must have adequate organ function (liver, kidney function and hematopoietic function tests) prior IBI319 administration

    1. Absolute neutrophil count (ANC) ≥1.5 x10^9/L
    2. Platelet count ≥ 100 x 10^9/L
    3. Hemoglobin ≥ 9 g / dL (whole blood or component transfusion within 7 days before 1st dose of study drug is prohibited)
    4. Renal function tests: an estimated glomerular filtration rate (eGFR) ≥ 50 mL/min
    5. Liver function tests alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x ULN, for patients with known liver cancer or liver metastases, AST and ALT ≤ 5 x ULN
    6. Total bilirubin (TBil) ≤1.5 x ULN; If Gilbert's Syndrome may have Bilirubin> 2 x ULN
    7. Coagulation tests: APTT ≤ 1.5 x ULN and INR ≤1.5 x ULN
  8. Subjects (males and females) of childbearing potential should be willing to use reliable contraception methods that are deemed effective by the investigator from visit 1 through 180 days following the last dose of study drug.

Exclusion Criteria:

  1. Legal incapacity or limited legal capacity.
  2. Pregnancy, lactation, breastfeeding.
  3. Prior treatment with an anti-CD137, anti-Programmed Death Receptor (PD)-1, anti-PD-L1, anti-PD-L2, anti-Cytotoxic T-Cell Lymphoma-4 Antigen (CTLA-4) antibody, or any other antibody or drug (except for Ib cohort A and B).
  4. NSCLC patients with EGFR mutations or ALK gene rearrangements.
  5. Colorectal cancer patients with KRAS mutation / BRAF mutation / HER2 overexpression.
  6. Concurrent anticancer treatment or use of other investigational product within 4 weeks before start of trial treatment; major surgery within 4 weeks before start of trial treatment (excluding prior diagnostic biopsy).
  7. Failure to recover from adverse events from the most recent anti-tumor treatment to CTCAE ≤ grade 1 or baseline with the exception of alopecia.
  8. Acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
  9. Subjects with CNS metastasis unless they are asymptomatic or adequately treated with radiotherapy and/or surgery and subjects are neurologically stable with minimal residual symptoms/signs.
  10. Any other serious underlying medical (e.g., uncontrolled hypertension, active uncontrolled infection, active gastric ulcer, uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, other serious cardiac conditions not listed in exclusion criteria), psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.


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: Fen Yao 0512-69566088
Listed Location Countries  ICMJE China
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04708210
Other Study ID Numbers  ICMJE CIBI319A101
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
Principal Investigator: Yilong Wu Guangdong Provincial People's Hospital
PRS Account Innovent Biologics (Suzhou) Co. Ltd.
Verification Date April 2021

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