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NCT Number: NCT06351020

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking Union Medical College Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LM-302

Drug

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

apatinib

Drug

The subjects will receive Apatinib orally,qd

Irinotecan

Drug

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

Primary outcomes

  1. Overall Survival (OS)

    Time frame: up to 42 months

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

  2. Progression Free Survival (PFS)

    Time frame: 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 outcomes

  1. Objective response rate (ORR)

    Time frame: 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.

  2. Duration of response (DoR)

    Time frame: 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.

  3. Disease control rate (DCR)

    Time frame: 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.

  4. AE and SAE

    Time frame: 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

  5. Evaluate the immunogenicity of LM-302

    Time frame: up to 42 months

    Anti-drug antibody (ADA) will be detected, the titer of ADA will be evaluated using the validated assay.

  6. Evaluation of pharmacokinetic characteristics of LM-302

    Time frame: up to 42 months

    Peak Plasma Concentration (Cmax) will be evaluated using PopPK model and simulation.

  7. Evaluation of pharmacokinetic characteristics of LM-302

    Time frame: up to 42 months

    Area under the plasma concentration versus time curve (AUC) will be evaluated using PopPK model and simulation.

  8. Evaluation of pharmacokinetic characteristics of LM-302

    Time frame: up to 42 months

    Trough concentration will be evaluated using PopPK model and simulation.

  9. Evaluation of pharmacokinetic characteristics of total antibody

    Time frame: up to 42 months

    Peak Plasma Concentration (Cmax) will be evaluated using PopPK model and simulation.

  10. Evaluation of pharmacokinetic characteristics of total antibody

    Time frame: up to 42 months

    Area under the plasma concentration versus time curve (AUC) will be evaluated using PopPK model and simulation.

  11. Evaluation of pharmacokinetic characteristics of total antibody

    Time frame: up to 42 months

    Trough concentration will be evaluated using PopPK model and simulation.

  12. Evaluation of pharmacokinetic characteristics of MMAE

    Time frame: up to 42 months

    Peak Plasma Concentration (Cmax) will be evaluated using PopPK model and simulation.

  13. Evaluation of pharmacokinetic characteristics of MMAE

    Time frame: up to 42 months

    Area under the plasma concentration versus time curve (AUC) will be evaluated using PopPK model and simulation.

  14. Evaluation of pharmacokinetic characteristics of MMAE

    Time frame: up to 42 months

    Trough concentration will be evaluated using PopPK model and simulation.

Sponsors and collaborators

Lead sponsor

LaNova Medicines Zhejiang Co., Ltd.

Industry

Registry information

Official study title

A Phase III, Open-Label, Multi Center, Randomized Study of LM-302 Versus Treatment of Physician's Choice (TPC) in Patients With CLDN18.2-Positive, Locally Advanced or Metastatic Gastric(GC) and Gastroesophageal Junction(GEJ) Adenocarcinoma.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2024
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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