A LM-302 Combination With Other Anti-Tumor Therapies Phase ll Study
An Open-label, Multicenter Phase II Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of the LM-302 Combination With Other Anti-tumor Treatment in Subjects With CLDN18.2-positive Advanced Gastro-Intestinal Cancer.
1 other identifier
interventional
276
1 country
1
Brief Summary
This study is to evaluate the efficacy of the LM-302 Combination With Other Therapies in patients with CLDN18.2-positive Advanced Digestive Tract Tumor.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2023
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2023
CompletedFirst Posted
Study publicly available on registry
July 6, 2023
CompletedStudy Start
First participant enrolled
July 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
September 12, 2025
September 1, 2025
2.9 years
June 19, 2023
September 6, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
PFS
Progression free survival according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
112 weeks
Secondary Outcomes (36)
ORR
112 weeks
DOR
112 weeks
DCR
112 weeks
OS
112 weeks
AEs
112 weeks
- +31 more secondary outcomes
Study Arms (2)
LM-302 in combination with Toripalimab
EXPERIMENTALLM-302 in combination with other therapies
EXPERIMENTALInterventions
Q2W/Q3W，Administered intravenously
Q2W/Q3W,Administered intravenously
BID,Oral Administration
Eligibility Criteria
You may qualify if:
- Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
- Aged 18-80 years old (including boundary values) .
- Eastern Cooperative Oncology Group (ECOG) performance status of0-1.
- Life expectancy ≥ 3 months.
- Subjects with advanced gastrointestinal tumors diagnosed histologically and/or cytologically and who have failed or are intolerant to prior standard first-line therapy (imaging confirmation required)
- CLDN18.2-positive subjects.
- At least one measurable lesion.
- 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.
You may not qualify if:
- Subjects with known HER2-positive gastric cancer/adenocarcinoma of the gastroesophageal junction
- Subjects have participated 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.
- Previous immunotherapy and grade ≥3 irAE or grade ≥2 immune-related myocarditis. (for cohorts treated with combination PD-1).
- Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
- Present peripheral sensory or motor neuropathy ≥ grade 2.
- Subjects with uncontrolled pain.
- Subjects with symptomatic/active central nervous system(CNS)metastases.
- Subject who have uncontrollable third space effusion.
- Subjects with known hypersensitivity to antibody therapy.
- Subjects have treated with the same target.
- Subjects have received Strong inhibitor/strong inducer of CYP3A4 within 14 days prior to first dose.
- Use of any live 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.
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai East Hospital
Shanghai, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jin Li
Shanghai East Hospital
- PRINCIPAL INVESTIGATOR
Jieer Ying
Zhejiang Cancer Hospital
- PRINCIPAL INVESTIGATOR
Haiping Jiang
Zhejiang University
- PRINCIPAL INVESTIGATOR
Rushen Zhao
Zibo Municipal Hospital
- PRINCIPAL INVESTIGATOR
Chunmei Bai
Peking Union Medical College Hospital
- PRINCIPAL INVESTIGATOR
Hongming Pan
Sir Run Run Shaw Hospital
- PRINCIPAL INVESTIGATOR
Jing Dai
Zhongnan Hospital
- PRINCIPAL INVESTIGATOR
Yiping Mou
Zhejiang Provincial People's Hospital
- PRINCIPAL INVESTIGATOR
Haijiao Yan
The First People's Hospital of Changzhou
- PRINCIPAL INVESTIGATOR
Aiping Zhou
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- PRINCIPAL INVESTIGATOR
Xianglin Yuan
Tongji Hospital
- PRINCIPAL INVESTIGATOR
Yabin Xia
First Affiliated Hospital of Wannan Medical College
- PRINCIPAL INVESTIGATOR
Mingzhu Huang
Fudan University
- PRINCIPAL INVESTIGATOR
Lixin Wan
Nanyang Central Hospital
- PRINCIPAL INVESTIGATOR
Jun Zhou
Shanghai Gaobo Cancer Hospital
- PRINCIPAL INVESTIGATOR
Youwei Zhang
Xuzhou Central Hospital
- PRINCIPAL INVESTIGATOR
Ning Wu
Shanghai Pudong New District Gongli Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2023
First Posted
July 6, 2023
Study Start
July 27, 2023
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2028
Last Updated
September 12, 2025
Record last verified: 2025-09