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

  • STATUS
    Recruiting
  • End date
    Aug 21, 2024
  • participants needed
    256
  • sponsor
    Innovent Biologics (Suzhou) Co. Ltd.
Updated on 15 May 2021

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

Details
Condition Advanced Malignant Tumors
Treatment IBI319
Clinical Study IdentifierNCT04708210
SponsorInnovent Biologics (Suzhou) Co. Ltd.
Last Modified on15 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures
Patients with advanced solid tumors or hematological malignancies who had failed standard treatment
Male or female subjects 18 years and 75 years
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
Eastern Cooperative Oncology Group (ECOG) Performance Status 1
Subjects with life expectancy of 12 weeks
Subjects must have adequate organ function (liver, kidney function and hematopoietic function tests) prior IBI319 administration
Absolute neutrophil count (ANC) 1.5 x10^9/L
Platelet count 100 x 10^9/L
Hemoglobin 9 g / dL (whole blood or component transfusion within 7 days before 1st dose of study drug is prohibited)
Renal function tests: an estimated glomerular filtration rate (eGFR) 50 mL/min
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
Total bilirubin (TBil) 1.5 x ULN; If Gilbert's Syndrome may have Bilirubin> 2 x ULN
Coagulation tests: APTT 1.5 x ULN and INR 1.5 x ULN
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

Legal incapacity or limited legal capacity
Pregnancy, lactation, breastfeeding
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)
NSCLC patients with EGFR mutations or ALK gene rearrangements
Colorectal cancer patients with KRAS mutation / BRAF mutation / HER2 overexpression
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)
Failure to recover from adverse events from the most recent anti-tumor treatment to CTCAE grade 1 or baseline with the exception of alopecia
Acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
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
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
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