A Phase I Study of IBI325 in Patients With Advanced Solid Tumor

Study Overview
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Brief Summary
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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 Title
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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

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: IBI325 + sintilimab
* Drug: IBI325


Participation Criteria
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Eligibility Criteria
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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 1. 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-

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IBI325 and sintilimab combination does-escalation<br> | Drug: IBI325 + sintilimab<br>* IBI325 + sintilimab combination does-escalation Patients will receive IBI325 and sintilimab until progressive disease, intolerability, or other reasons leading to treatment discontinuation<br>|
| Experimental: IBI325 monotherapy does-escalation<br> | Drug: IBI325<br>* IBI325 monotherapy does-escalation Patients will receive IBI325 until progressive disease, intolerability, or other reasons leading to treatment discontinuation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with DLT | Number of patients who experienced a dose-limiting toxicity within the first 28 days after the first dose | 28 days post first dose | 
| Number of patients with treatment related AEs | Number of patients who experienced a treatment related AEs from the first dose until 90days after the last dose | Up to 90 days post last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with response | Number of patients with response per RECIST 1.1 | Every 6 weeks until progressive disease or up to 24 months after treatment | 
| 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 | 
| The half-life (t1/2) |  | Up to 90 days post last dose | 
| Positive rate of ADA and Nab |  | Up to 90 days post last dose |