To Evaluate the Safety, Tolerability, and Initial Efficacy of IBI318 in Patients With Advanced Malignancy, Multicenter, IA/IB Study

Innovent Biologics (Suzhou) Co. Ltd.1 site in 1 country103 target enrollmentApril 19, 2019

ConditionsAdvanced Malignancy

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Advanced Malignancy
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Enrollment: 103
Locations: 1
Primary Endpoint: Number of participants experiencing clinical and laboratory adverse events (AEs)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

An open label, multicenter, phase Ia/Ib study to evaluate the safety, tolerability, and initial efficacy of IBI318 in the treatment of patients with advanced malignancies.

Detailed Description

An open label, multicenter, phase Ia/Ib study to evaluate the safety, tolerability, and initial efficacy of IBI318 in the treatment of patients with advanced malignancies.

Registry

clinicaltrials.gov

Start Date

April 19, 2019

End Date

February 16, 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

•Sign the informed consent form
•Men or women 18 years or older
•Expected survival time ≥ 12 weeks
•Tumor assessment according to RECIST v1.1, at least one measurable lesion
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•Have adequate organ and bone marrow function
•Male participants and female participants must agree to use contraception during the treatment period and within 180 days after the treatment period
•Female subjects must not be pregnant or breastfeeding. If premenopausal, negative urine or serum pregnancy tests are required
•Ia: Subjects with locally advanced, recurrent or metastatic histologically or cytologically confirmed solid tumors or hematologic tumors and are refractory or intolerant to existing standard treatments
•Ib: Metastatic non-small cell lung cancer, advanced liver cancer, advanced esophageal squamous cell cancer, advanced gastric cancer, or other tumors that have been proved by histology or cytology with initial therapeutic effect in Phase Ia

Exclusion Criteria

•Previous exposure to immunotherapy including but not limited to, anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anti-tumor vaccine
•Participation in another interventional clinical study, an observational (non-interventional) clinical study, or a follow-up phase of an interventional study
•Receive last anti-tumor treatment within 4 weeks prior to the first dose of study drug
•Use of immunosuppressive drugs within 4 weeks prior to the first dose of study drug
•Require long-term steroid therapy or any other form of immunosuppressive therapy not including inhaled steroids
•Toxicity (excluding hair loss or fatigue) caused by previous antitumor therapy that did not recover to NCI CTCAE v 5.0 level 0-1 within 4 weeks prior to the first dose of study drug
•Received major surgery or has unhealed wounds, ulcers, or fractures within 4 weeks prior to the first dose of study drug
•Expect to receive other anti-tumor treatments during study (allowing palliative radiotherapy)
•History of infectious pneumonitis that required steroids or has current pneumonitis
•Known active untreated CNS metastases and/or spinal cord compression and/or cancerous meningitis, or with a history of soft meningeal cancer

Outcomes

Primary Outcomes

Number of participants experiencing clinical and laboratory adverse events (AEs)

Time Frame: Up to 90 days post last dose

Number of all study participants who demonstrate a tumor response

Time Frame: up to 24 months

Number of participants experiencing dose-limiting toxicities (DLTs)

Time Frame: 28 days within first dose in phase Ia

Secondary Outcomes

Positive rate of ADA and Nab(Up to 90 days post last dose)
The area under the curve (AUC) of plasma concentration of drug against time after administration of IBI318(Up to 90 days post last dose)
Time at which maximum concentration (Tmax) occurs for IBI318(Up to 90 days post last dose)
Maximum concentration (Cmax) after first dose interval of IBI318(Up to 90 days post last dose)
The half-life (t1/2) of IBI318 in plasma(Up to 90 days post last dose)