LM-302 for the Treatment of Subjects With Claudin18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma.

NCT06351020 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: LM302-03-101
• Study Type: interventional
• Target: 387
• Locations: 1 country
• Sites: 2

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

Conditions

Locally Advanced or Metastatic GC and GCJ Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• Overall Survival (OS)

  OS was defined defined as the time from date of randomization until death from any cause.

  up to 42 months

• Progression Free Survival (PFS)

  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

  up to 42 months

Secondary Outcomes (14)

• Objective response rate (ORR)

  From start of treatment to date of documented disease progression, up to approximately 42 months

• 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

• Disease control rate (DCR)

  From start of treatment to date of documented disease progression, up to approximately 42 months

• 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

• Evaluate the immunogenicity of LM-302

  up to 42 months

Study Arms (2)

LM-302

EXPERIMENTAL

Patients will accept LM-302 monotherapy

Drug: LM-302

Physician's choice Apatinib or Irinotecan

ACTIVE COMPARATOR

Patients will accept Apatinib or Irinotecan monotherapy

Drug: Apatinib; Drug: Irinotecan

Interventions

LM-302 DRUG

LM-302 intravenous-injection every 2 weeks on Day 1 of each 14-day cycle

LM-302

Apatinib DRUG

The subjects will receive Apatinib orally,qd

Physician's choice Apatinib or Irinotecan

Irinotecan DRUG

The subjects will receive Irinotecan intravenous-injection,every 2 weeks on Day 1 of each 14-day cycle

Physician's choice Apatinib or Irinotecan

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• LaNova Medicines Zhejiang Co., Ltd.: lead

Study Sites (2)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100000, China

Location

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Interventions

apatinib; Irinotecan

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Chunmei Bai

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

• Jin Li

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: experimental arm:LM-302 control arm:Apatinib or Irinotecan

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: April 8, 2024
• Study Start: June 24, 2024
• Primary Completion (Estimated): November 10, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

CN (2)