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

An Open-label, Multicenter, Phase Ia/Ib Study to Evaluate the Safety, Tolerance and Preliminary Efficacy of IBI319 in Patients With Advanced Malignant Tumors

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 Overview

• Status: Active, not recruiting
• Conditions: Advanced Malignant Tumors
• Intervention / Treatment: Drug: IBI319

• Study Type: Interventional
• Enrollment (Anticipated): 256
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong, China
    • Guangdong Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

    -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Phase Ia Dose-Escalation Stage: IBI319	Drug: IBI319; Iv infusion day 1 of every 14 or 21 days in Phase Ia until disease progression or loss of clinical benefit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	up to 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall response rate (ORR) based on RECIST v1.1 criteria and Lugano 2014 criteria.	up to 2 years
Progression-free survival (PFS) based on RECIST v1.1 criteria and Lugano 2014 criteria	up to 2 years
Overall Survival (OS) based on RECIST v1.1 criteria and Lugano 2014 criteria	up to 2 years
Time To Response(TTR) based on RECIST v1.1 criteria and Lugano 2014 criteria	up to 2 years
Duration of Response(DOR) based on RECIST v1.1 criteria and Lugano 2014 criteria	up to 2 years

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 28, 2021
• Primary Completion (ANTICIPATED): December 21, 2022
• Study Completion (ANTICIPATED): June 21, 2023

Study Registration Dates

• First Submitted: January 7, 2021
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (ACTUAL): January 13, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 10, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CIBI319A101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No