A Phase Ia, Open-Label, Multi-Center, Study of the Safety, Tolerability and Primary Efficacy of IBI321 in Patients With Advanced Solid Tumors

Innovent Biologics (Suzhou) Co. Ltd.1 site in 1 country36 target enrollmentJune 24, 2021

ConditionsAdvanced Solid Tumors

InterventionsIBI321

DrugsIBI321

Overview

Phase: Phase 1
Intervention: IBI321
Conditions: Advanced Solid Tumors
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Enrollment: 36
Locations: 1
Primary Endpoint: Percentage of Participants with Adverse Events (AEs), treatment-related AE (TRAE), immune-related AEs (irAE) and serious adverse event (SAE) per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 ;
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This first-in-human open-label,dose-escalation study is designed to evaluate the safety, tolerability, and primary efficacy of IBI321 in participants with locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has proven to be ineffective or intolerable.

Registry

clinicaltrials.gov

Start Date

June 24, 2021

End Date

February 23, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Sequential

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 who had failed standard treatment.
•Male or female subjects ≥18 years and ≤75 years.
•At least one measurable lesion per RECIST version 1.1
•Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
•Life expectancy of ≥ 12 weeks.
•Adequate hematologic and end organ function

Exclusion Criteria

•Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, targeted therapy, or immunotherapy.
•Failure to recover from adverse events from the most recent anti-tumor treatment
•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.
•Pregnancy, lactation, breastfeeding

Arms & Interventions

Phase Ia Dose-Escalation Stage: IBI321

Intervention: IBI321

Outcomes

Primary Outcomes

Percentage of Participants with Adverse Events (AEs), treatment-related AE (TRAE), immune-related AEs (irAE) and serious adverse event (SAE) per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 ;

Time Frame: From Day 1 to up to 2 years

Percentage of Participants with Dose-Limiting Toxicities (DLTs)

Time Frame: From Day 1 of Cycle 1 to Day 28

Secondary Outcomes

Objective Response Rate (ORR)per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.(From Baseline until disease progression (up to 2 years))
Overall Survival (OS)(From Baseline until disease progression (up to 2 years))
Percentage of Participants with Anti-Drug Antibodies (ADAs) and Neutralizing Antibody (Nab) to IBI321(From Day 1 up to 2 years)
Minimum Serum Concentration (Cmin) of IBI321(From Day 1 up to 2 years)
Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.(From Baseline until disease progression (up to 2 years))
Duration of Response (DoR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.(From Baseline until disease progression (up to 2 years))
Maximum Serum Concentration (Cmax) of IBI321(From Day 1 up to 2 years)
Clearance (CL) of IBI321(From Day 1 up to 2 years)
Area Under the Concentration-Time Curve (AUC) of IBI321(From Day 1 up to 2 years)