A Phase I, Open-label, Multicenter, Dose-escalation Study Evaluating the Safety, Tolerability, and Potential Efficacy of IBI325, an Anti-CD73 Antibody, in Patients With Advanced Solid Tumor

Innovent Biologics (Suzhou) Co. Ltd.1 site in 1 country48 target enrollmentFebruary 8, 2022

ConditionsSolid Tumor

InterventionsIBI325 + sintilimab IBI325

DrugsIBI325 + sintilimab IBI325

Overview

Phase: Phase 1
Intervention: IBI325 + sintilimab
Conditions: Solid Tumor
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Enrollment: 48
Locations: 1
Primary Endpoint: Number of patients with DLT
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI325 in patients with advanced solid tumors

Registry

clinicaltrials.gov

Start Date

February 8, 2022

End Date

August 8, 2023

Last Updated

2 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

•Histologically confirmed, locally advanced unresectable or metastatic tumors.
•At least one evaluable or measurable lesion per RECIST 1.1
•Male or female subject at least 18 years old and no more than 75 years old.
•Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 or
•Must have adequate organ function
•Be able to provide archived or fresh tumor tissues-

Exclusion Criteria

•Previous exposure to any anti-CD73 monoclonal antibody
•Subjects participating in another interventional clinical study, except for during the survival follow-up phase of the studies.
•Unstable central nervous system netastases
•Known active autoimmune disease or inflammatory disease
•Known active infectious disease
•Other uncontrolled systematic disease that may increase the risk of participating the study-

Arms & Interventions

IBI325 and sintilimab combination does-escalation

Intervention: IBI325 + sintilimab

IBI325 monotherapy does-escalation

Intervention: IBI325

Outcomes

Primary Outcomes

Number of patients with DLT

Time Frame: 28 days post first dose

Number of patients who experienced a dose-limiting toxicity within the first 28 days after the first dose

Number of patients with treatment related AEs

Time Frame: Up to 90 days post last dose

Number of patients who experienced a treatment related AEs from the first dose until 90days after the last dose

Secondary Outcomes

Positive rate of ADA and Nab(Up to 90 days post last dose)
The area under the curve (AUC)(Up to 90 days post last dose)
Maximum concentration (Cmax)(Up to 90 days post last dose)
Time at which maximum concentration (Tmax)(Up to 90 days post last dose)
Number of patients with response(Every 6 weeks until progressive disease or up to 24 months after treatment)
The half-life (t1/2)(Up to 90 days post last dose)