Clinical trial NCT05934331: A LM-302 Combined With Toripalimab Phase II Study
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Gastric Cancer
Pancreatic Cancer
Lead sponsor: LaNova Medicines Limited
Sponsor class: INDUSTRY
First posted: 2023-07-06
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: PFS
timeFrame: up to 6 weeks following first dose.
Secondary outcomes:
measure: ORR
timeFrame: up to 6 weeks following first dose.
measure: DOR
timeFrame: up to 6 weeks following first dose.
measure: DCR
timeFrame: up to 6 weeks following first dose.
measure: OS
timeFrame: up to 6 weeks following first dose.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital
Study officials:
affiliation: Shanghai East Hospital
name: Jin Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhejiang Cancer Hospital
name: Jieer Ying
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhejiang University
name: Haiping Jiang
role: PRINCIPAL_INVESTIGATOR
affiliation: Zibo Central Hospital
name: Rushen Zhao
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking Union Medical College Hospital
name: Chunmei Bai
role: PRINCIPAL_INVESTIGATOR
affiliation: Sir Run Run Shaw Hospital
name: Hongming Pan
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuhan University
name: Jing Dai
role: PRINCIPAL_INVESTIGATOR
affiliation: Hubei Cancer Hospital
name: Huiting Xu
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhejiang Provincial People's Hospital
name: Yiping Mou
role: PRINCIPAL_INVESTIGATOR
affiliation: The First People's Hospital of Changzhou
name: Haijiao Yan
role: PRINCIPAL_INVESTIGATOR
affiliation: Chongqing University Cancer Hospital
name: Jianlin Long
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: aiping Zhou
role: PRINCIPAL_INVESTIGATOR
affiliation: Tongji Hospital
name: Xianglin Yuan
role: PRINCIPAL_INVESTIGATOR
affiliation: Shenzhen University General Hospital
name: Guocheng Zhong
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Wannan Medical College
name: Yabin Xia
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Ting Deng
role: PRINCIPAL_INVESTIGATOR
affiliation: The Sixth Affiliated Hospital. Sun Yat-sen Universitv Guangdong Gastrointestinal Hospital
name: Yanhong Deng
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Mingzhu Huang
role: PRINCIPAL_INVESTIGATOR
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