Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI345

Study Overview
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Brief Summary
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A phase Ia study to evaluate the safety, tolerance, pharmacokinetics and preliminary efficacy of IBI345 in patients with CLDN18.2 positive solid tumors

Official Title
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A Phase Ia Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI345 in Patients With CLDN18.2-positive Solid Tumors

Conditions
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CLDN18.2 Positive Solid Tumors

Intervention / Treatment
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* Drug: IBI345


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years and ≤75 years. Histologically or cytologically confirmed CLDN18.2 positive patients with advanced gastric cancer or pancreatic cancer who failed standard therapy . There are assessable lesions according to RECIST V1.1 (solid tumor efficacy evaluation criteria). Expected survival time ≥12 weeks. ECOG PS 0 1. Exclusion Criteria: Participating in another interventional clinical study, other than observational (non-interventional) clinical study or in the survival follow-up phase of the interventional study. Received any antitumor drug within 2 weeks prior to apheresis or initial administration of the investigational drug. Use of immunosuppressive drugs within 1 week prior to apheresis or 2 weeks prior to initial administration of the investigational drug. Long-term systemic steroid or any other immunosuppressive drug therapy is required, not including inhaled steroid therapy. Receive live attenuated vaccine within 4 weeks prior to initial administration of the study drug or plan to receive live attenuated vaccine during the study period. Toxicity (excluding alopecia, fatigue, and hematological toxicity) that did not return to equal to or lower than Grade 1 of NCI CTCAE V5.0 from previous antitumor therapy prior to initial administration of the investigational drug.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: IBI345<br>Single arm | Drug: IBI345<br>* IBI345 CAR-T cell injection by intravenous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. |  | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) according to RECIST version 1.1 | Defined as the proportion of subjects with confirmed complete response (CR) or partial response (PR); a confirmed response is a response that persists on repeat-imaging ≥4 weeks after initial documentation of response. | up to 2 years | 
| Duration of Response (DOR) according to RECIST version 1.1 | Defined as time from date of first objective response (either CR or PR) to first documentation of radiographic disease progression or death due to any cause, whichever occurs first. | up to 2 years | 
| Disease Control Rate (DCR) according to RECIST version 1.1 | Defined as the proportion of subjects who have achieved CR, PR, or stable disease (duration of stable disease should be ≥3 months). | up to 2 years | 
| Time to Response (TTR) according to RECIST version 1.1 | Defined as the time from first dose to first documentation of objective response (either CR or PR). | up to 2 years | 
| Progression-Free Survival (PFS) according to RECIST version 1.1 | Defined as the time from first dose to first documentation of radiographic disease progression or death due to any cause, whichever occurs first. | up to 2 years | 
| Overall Survival (OS) according to RECIST version 1.1 | Defined as the time from first dose to the date of death due to any cause. | up to 2 years | 
| Peak Plasma Concentration (Cmax) |  | up to 1 years | 
| Area under theplasma concentration versus time curve (AUC) |  | up to 1 years | 
| Time of maximum drug concentration in hours [Tmax] |  | up to 1 years | 
| Elimination half-life in hours [t1/2] |  | up to 1 years | 
| Clearance (CL) |  | up to 1 years | 
| Distribution Volume (Vd) |  | up to 1 years | 
| Number of Participants With anti-drug antibody (ADA) |  | up to 1 years | 
| Number of Participants With Neutralizing Antibodies (NAbs) |  | up to 1 years |