LM-302 for the Treatment of Subjects With Claudin18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma.
- Conditions
- Locally Advanced or Metastatic GC and GCJ Adenocarcinoma
- Interventions
- Registration Number
- NCT06351020
- Lead Sponsor
- LaNova Medicines Zhejiang Co., Ltd.
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 375
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LM-302 LM-302 Patients will accept LM-302 monotherapy Physician's choice Apatinib or Irinotecan Apatinib Patients will accept Apatinib or Irinotecan monotherapy Physician's choice Apatinib or Irinotecan Irinotecan Patients will accept Apatinib or Irinotecan monotherapy
- Primary Outcome Measures
Name Time Method Overall Survival (OS) up to 42 months OS was defined defined as the time from date of randomization until death from any cause.
Progression Free Survival (PFS) up to 42 months PFS was defined as the time from date of randomization until first objective radiographic tumor progression or death from any cause, based on Investigator assessment
- Secondary Outcome Measures
Name Time Method Evaluation of pharmacokinetic characteristics of LM-302 up to 42 months Trough concentration will be evaluated using PopPK model and simulation.
Disease control rate (DCR) From start of treatment to date of documented disease progression, up to approximately 42 months defined as the proportion of participants who achieved CR, PR, or stable disease (SD) for a minimum of 6 weeks during study treatment, based on Investigator assessment.
Evaluation of pharmacokinetic characteristics of MMAE up to 42 months Trough concentration will be evaluated using PopPK model and simulation.
Objective response rate (ORR) From start of treatment to date of documented disease progression, up to approximately 42 months defined as the proportion of participants who achieve a best response of complete response (CR) or partial response (PR) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by Investigator.
AE and SAE From signing the ICF until 28 days after EOT or accept other anti-cancer therapy,up to 40 days after last study dose Adverse events will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0
Evaluate the immunogenicity of LM-302 up to 42 months Anti-drug antibody (ADA) will be detected, the titer of ADA will be evaluated using the validated assay.
Duration of response (DoR) Time from initial response (CR or PR) to date of documented disease progression or death (due to any cause) whichever occurs first, up to approximately 42 months defined time from the initial response (CR or PR) until documented tumor progression or death from any cause and based on Investigator assessment.
Evaluation of pharmacokinetic characteristics of total antibody up to 42 months Trough concentration will be evaluated using PopPK model and simulation.
Trial Locations
- Locations (2)
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Shanghai East Hospital
🇨🇳Shanghai, Shanghai, China