A LM-302 Combined With Toripalimab Phase II Study

Study Overview
=================
Brief Summary
-----------------
A Phase II, Open-Label, Multicenter Study Evaluating the Efficacy, Safety, and Tolerability of LM-302 Combined With Toripalimab in CLDN18.2 Positive Patients advanced gastro-Intestinal Cancer

Detailed Description
-----------------
Primary Objective: To evaluate the efficacy of the LM-302 + Toripalimab regimen in subjects with CLDN18.2-positive advanced gastro-Intestinal cancer Secondary Objectives: To evaluate the correlation between CLDN18.2 and PD-L1 expression levels and the antitumor activity of the LM-302 + Toripalimab regimen.

Official Title
-----------------
A Phase II, Open-Label, Multicenter Study Evaluating the Efficacy, Safety, and Tolerability of LM-302 Combined With Toripalimab in CLDN18.2 Positive Patients Advanced Gastro-Intestinal Cancer

Conditions
-----------------
Gastric Cancer, Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: LM302+Toripalimab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who fully understand the purpose, nature, methods, and possible adverse reactions of the trial, voluntarily participate in the trial, and have signed the Informed Consent Form (ICF) before any procedure begins. Male or female subjects aged 18-80 years (both inclusive) at the time of signing the ICF. ECOG performance score of 0-1. Subjects with an expected survival ≥ 3 months. Diagnosed histologically or cytologically with local advanced gastro-Intestinal cancer CLDN18.2-positive subjects. Subjects with at least 1 measurable lesion according to RECIST v1.1. Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose. Subjects who are able to communicate well with investigators and understand and adhere to the requirements of this study. Exclusion Criteria: Participate in any other clinical trial within 28 days prior to 1st dosing of investigational medicinal product (IMP). Subjects with anti-tumor treatment within 21 days prior to 1st dosing of IMP. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0. Subjects with uncontrolled pain. Use of any live attenuated vaccines within 28 days prior to 1st dosing of IMP. Subjects with current or previous interstitial lung diseases or pneumonia requiring oral or intravenous glucocorticoids for adjuvant therapy. Subjects on anticoagulants, such as heparin and vitamin K antagonists. Subjects who have undergone major surgery or received interventional therapy (excluding tumor biopsy or aspiration) within 28 days before the first dose. Subjects with a history of malignancies other than the tumors investigated in this study within 2 years prior to the first dose. Subjects who have severe cardiovascular disease. Subjects with a known history of autoimmune diseases. Subjects who have a history of immunodeficiency disease. Subjects with HIV infection, active HBV or HCV infection. Child-bearing potential female who have positive results in pregnancy test within 7 days before the first dose or are lactating. Subjects who have psychiatric illness or disorders that may preclude study compliance and subject who is judged as not eligible to participate in this study by the investigator.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LM-302 in combination with Toripalimab<br>LM-302 (recombinant humanized anti-CLDN18.2 monoclonal antibody, MMAE conjugate), Toripalimab(recombinant humanized anti-PD1 monoclonal antibody) | Drug: LM302+Toripalimab<br>* LM-302 in combination with Toripalimab.<br>* Other names: LM302+JS001;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression free survival according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) | up to 6 weeks following first dose. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Objective response rate (ORR) | up to 6 weeks following first dose. | 
| DOR | Duration of response (DOR) | up to 6 weeks following first dose. | 
| DCR | Disease control rate (DCR = CR + PR + SD) | up to 6 weeks following first dose. | 
| OS | Overall survival (OS) | up to 6 weeks following first dose. |