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

Innovent Biologics (Suzhou) Co. Ltd.1 site in 1 country256 target enrollmentApril 28, 2021

ConditionsAdvanced Malignant Tumors

InterventionsIBI319

DrugsIBI319

Overview

Phase: Phase 1
Intervention: IBI319
Conditions: Advanced Malignant Tumors
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Enrollment: 256
Locations: 1
Primary Endpoint: 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
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

April 28, 2021

End Date

June 21, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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 ≤
•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)

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.

Arms & Interventions

Phase Ia Dose-Escalation Stage: IBI319

Intervention: IBI319

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)