Locally Advanced or Metastatic GC and GCJ Adenocarcinoma
Conditions
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
Interventions
DRUGLM-302
LM-302 intravenous-injection every 2 weeks on Day 1 of each 14-day cycle
DRUGApatinib
The subjects will receive Apatinib orally,qd
DRUGIrinotecan
The subjects will receive Irinotecan intravenous-injection,every 2 weeks on Day 1 of each 14-day cycle
Sponsors
LaNova Medicines Zhejiang Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
experimental arm:LM-302 control arm:Apatinib or Irinotecan
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| Evaluation of pharmacokinetic characteristics of LM-302 | up to 42 months | Peak Plasma Concentration (Cmax) will be evaluated using PopPK model and simulation. |
| Evaluation of pharmacokinetic characteristics of total antibody | up to 42 months | Peak Plasma Concentration (Cmax) will be evaluated using PopPK model and simulation. |
| Evaluation of pharmacokinetic characteristics of MMAE | up to 42 months | Peak Plasma Concentration (Cmax) will be evaluated using PopPK model and simulation. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORChunmei Bai
Peking Union Medical College Hospital
PRINCIPAL_INVESTIGATORJin Li
Shanghai East Hospital
Outcome results
None listed