A Phase Ib Study of Primary Efficacy and Safety of IBI321 Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This is open-label, multicenter, Phase Ib study is designed to evaluate the Primary Efficacy and Safety of IBI321 Monotherapy or Combination Therapy in participants with advanced solid tumors.

Official Title
-----------------
A Phase Ib, Open-Label, Multi-Center, Study of Primary Efficacy and Safety of IBI321 Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors

Conditions
-----------------
Advanced Solid Tumors

Intervention / Treatment
-----------------
* Drug: IBI321


Participation Criteria
=================
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. 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: Failure to recover from adverse events from the most recent anti-tumor treatments 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. Previous exposure to any anti-TIGIT antibody, or recombinant protein.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IBI321 in advanced solid tumors<br> | Drug: IBI321<br>* IBI321 at a dose no higher than RP2D, D1 IV Q3W.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators. |  | From Baseline until disease progression (up to 2 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS), According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators. |  | From Baseline until disease progression (up to 2 years) | 
| Overall Survival (OS) |  | From Day 1 to up to 2 years | 
| Percentage of Participants with Adverse Events (AEs) per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 |  | From Day 1 to up to 2 years | 
| Area Under the Concentration-Time Curve (AUC) of IBI321 |  | From Day 1 up to 2 years | 
| Maximum Serum Concentration (Cmax) of IBI321 |  | From Day 1 up to 2 years | 
| Minimum Serum Concentration (Cmin) of IBI321 |  | From Day 1 up to 2 years | 
| Clearance (CL) of IBI321 |  | From Day 1 up to 2 years | 
| Percentage of Participants with Anti-Drug Antibodies (ADAs) to IBI321 |  | From Day 1 up to 2 years | 
| Percentage of Participants with Neutralizing Antibody (Nab) to IBI321 |  | From Day 1 up to 2 years |