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

NCT04708210 | Unknown Phase 1

• 1 other identifier: CIBI319A101
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Malignant Tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

Phase Ia Dose-Escalation Stage: IBI319

EXPERIMENTAL

Drug: IBI319

Interventions

IBI319 DRUG

Iv infusion day 1 of every 14 or 21 days in Phase Ia until disease progression or loss of clinical benefit.

Phase Ia Dose-Escalation Stage: IBI319

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Guangdong Provincial People's Hospital

Guangdong, China

Location

Study Officials

• Yilong Wu

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 13, 2021
• Study Start: April 28, 2021
• Primary Completion: December 21, 2022
• Study Completion: June 21, 2023
• Last Updated: October 12, 2022

Record last verified: 2022-10

Locations

CN (1)