Completed

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

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What is being tested

IBI325 + sintilimab

+ IBI325

Drug
Who is being recruted

From 18 to 75 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: February 2022
See protocol details

Summary

Principal SponsorInnovent Biologics (Suzhou) Co. Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 8, 2022

Actual date on which the first participant was enrolled.

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

Official TitleA 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
NCT05119998
Principal SponsorInnovent Biologics (Suzhou) Co. Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

48 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

6 inclusion criteria required to participate
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 1.
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6 exclusion criteria prevent from participating
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
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Shandong Province Cancer Hospital

Jinan, ChinaOpen Shandong Province Cancer Hospital in Google Maps
CompletedOne Study Center