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Trial Title:
A LM-302 Combined With Toripalimab Phase II Study
NCT ID:
NCT05934331
Condition:
Gastric Cancer
Pancreatic Cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
LM302+Toripalimab
Description:
LM-302 in combination with Toripalimab.
Arm group label:
LM-302 in combination with Toripalimab
Other name:
LM302+JS001
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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.
2. Male or female subjects aged 18-80 years (both inclusive) at the time of signing the
ICF.
3. ECOG performance score of 0-1.
4. Subjects with an expected survival ≥ 3 months.
5. Diagnosed histologically or cytologically with local advanced gastro-Intestinal
cancer
6. CLDN18.2-positive subjects.
7. Subjects with at least 1 measurable lesion according to RECIST v1.1.
8. Subjects must show appropriate organ and marrow function in laboratory examinations
within 7 days prior to the first dose.
9. Subjects who are able to communicate well with investigators and understand and
adhere to the requirements of this study.
Exclusion Criteria:
1. Participate in any other clinical trial within 28 days prior to 1st dosing of
investigational medicinal product (IMP).
2. Subjects with anti-tumor treatment within 21 days prior to 1st dosing of IMP.
3. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1
of CTCAE v5.0.
4. Subjects with uncontrolled pain.
5. Use of any live attenuated vaccines within 28 days prior to 1st dosing of IMP.
6. Subjects with current or previous interstitial lung diseases or pneumonia requiring
oral or intravenous glucocorticoids for adjuvant therapy.
7. Subjects on anticoagulants, such as heparin and vitamin K antagonists.
8. Subjects who have undergone major surgery or received interventional therapy
(excluding tumor biopsy or aspiration) within 28 days before the first dose.
9. Subjects with a history of malignancies other than the tumors investigated in this
study within 2 years prior to the first dose.
10. Subjects who have severe cardiovascular disease.
11. Subjects with a known history of autoimmune diseases.
12. Subjects who have a history of immunodeficiency disease.
13. Subjects with HIV infection, active HBV or HCV infection.
14. Child-bearing potential female who have positive results in pregnancy test within 7
days before the first dose or are lactating.
15. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai East Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Jin Li
Start date:
July 27, 2023
Completion date:
January 1, 2026
Lead sponsor:
Agency:
LaNova Medicines Zhejiang Co., Ltd.
Agency class:
Industry
Source:
LaNova Medicines Limited
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05934331
