Clinical trial NCT04708210: Study of the Efficacy and Safety of IBI319 in Patients With Advanced Malignant Tumors
Official title: An Open-label, Multicenter, Phase Ia/Ib Study to Evaluate the Safety, Tolerance and Preliminary Efficacy of IBI319 in Patients With Advanced Malignant Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Malignant Tumors
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2021-01-13
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

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Primary outcomes:
measure: 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
timeFrame: up to 2 years
Secondary outcomes:
measure: Overall response rate (ORR) based on RECIST v1.1 criteria and Lugano 2014 criteria.
timeFrame: up to 2 years
measure: Progression-free survival (PFS) based on RECIST v1.1 criteria and Lugano 2014 criteria
timeFrame: up to 2 years
measure: Overall Survival (OS) based on RECIST v1.1 criteria and Lugano 2014 criteria
timeFrame: up to 2 years
measure: Time To Response(TTR) based on RECIST v1.1 criteria and Lugano 2014 criteria
timeFrame: up to 2 years
measure: Duration of Response(DOR) based on RECIST v1.1 criteria and Lugano 2014 criteria
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Guangdong
country: China
facility: Guangdong Provincial People's Hospital
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Yilong Wu
role: PRINCIPAL_INVESTIGATOR
References: