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Trial Title:
LM-302 for the Treatment of Subjects With Claudin18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma.
NCT ID:
NCT06351020
Condition:
Locally Advanced or Metastatic GC and GCJ Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Irinotecan
Apatinib
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
experimental arm:LM-302 control arm:Apatinib or Irinotecan
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
LM-302
Description:
LM-302 intravenous-injection every 2 weeks on Day 1 of each 14-day cycle
Arm group label:
LM-302
Intervention type:
Drug
Intervention name:
Apatinib
Description:
The subjects will receive Apatinib orally,qd
Arm group label:
Physician's choice Apatinib or Irinotecan
Intervention type:
Drug
Intervention name:
Irinotecan
Description:
The subjects will receive Irinotecan intravenous-injection,every 2 weeks on Day 1 of each
14-day cycle
Arm group label:
Physician's choice Apatinib or Irinotecan
Summary:
This study will assess the efficacy and safety of LM-302 Versus Treatment of Physician's
Choice (TPC) in Subjects With locally advanced or metastatic, Claudin (CLDN)
18.2-positive, Gastric or Gastroesophageal Junction Adenocarcinoma who have progressed on
or after 2 lines of systemic therapy
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age 18-80 years old, male and female
- Has histopathologically confirmed unresectable locally advanced or metastatic
adenocarcinoma of the gastric/gastroesophageal junction (G/GEJ AC).
- Has received and progressed on at least 2 lines of systemic therapy. A prior
(neo)adjuvant systemic therapy that ended within 6 months prior to disease relapse
is defined as the first line therapy.
- Centrally confirmed CLDN18.2-positive
- HER2 negative
- At least one measurable lesion according to the solid tumor response Evaluation
Criteria (RECIST 1.1)
- ECOG: 0-1
- Expected survival ≥12 weeks;
- Good blood reserve and liver, kidney and coagulation function
- Willing to provide informed consent for study participation.
Exclusion Criteria:
- Within the first 5 years of randomization, there is a history of malignant tumors
other than GC/GEJ adenocarcinoma, except for skin basal cell carcinoma, cervical
carcinoma in situ, breast carcinoma in situ, and skin squamous cell carcinoma that
have been cured and cured after treatment
- Individuals with a history of previous immunodeficiency, including those with other
acquired or congenital immunodeficiency diseases, or those with a history of organ
transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic
stem cell transplantation
- Urine protein qualitative result ≥ 3+, or urine protein qualitative result is 2+and
24-hour urine protein quantification>1g
- Individuals with a history of severe cardiovascular and cerebrovascular diseases
- Individuals who are unable to control or have serious illnesses, including but not
limited to active infections requiring systemic antibiotic treatment within 2 weeks
prior to initial medication, interstitial pneumonia/lung disease requiring
intervention during screening, and tumor related pain requiring local treatment
during screening
- Current peripheral sensory or motor neuropathy ≥ grade 2
- Uncontrollable third space effusion in clinical practice
- Received or planned to undergo major surgery or intervention during the study period
within the first 28 days of randomization
- The researcher determined that there are other situations that are not suitable for
participation in this study
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100000
Country:
China
Status:
Recruiting
Contact:
Last name:
chunmei bai, doctor
Facility:
Name:
Shanghai East Hospital
Address:
City:
Shanghai
Zip:
200000
Country:
China
Status:
Recruiting
Contact:
Last name:
jin li, doctor
Start date:
June 24, 2024
Completion date:
December 15, 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/NCT06351020
