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

Last updated: June 28, 2024
Sponsor: LaNova Medicines Zhejiang Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Adenocarcinoma

Treatment

Apatinib

Irinotecan

LM-302

Clinical Study ID

NCT06351020
LM302-03-101
  • Ages 18-80
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18-80 years old, male and female

  • Has histopathologically confirmed unresectable locally advanced or metastaticadenocarcinoma 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 relapseis defined as the first line therapy.

  • Centrally confirmed CLDN18.2-positive

  • HER2 negative

  • At least one measurable lesion according to the solid tumor response EvaluationCriteria (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

Exclusion Criteria:

  • Within the first 5 years of randomization, there is a history of malignant tumorsother than GC/GEJ adenocarcinoma, except for skin basal cell carcinoma, cervicalcarcinoma in situ, breast carcinoma in situ, and skin squamous cell carcinoma thathave been cured and cured after treatment

  • Individuals with a history of previous immunodeficiency, including those with otheracquired or congenital immunodeficiency diseases, or those with a history of organtransplantation, allogeneic bone marrow transplantation, or autologous hematopoieticstem 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 notlimited to active infections requiring systemic antibiotic treatment within 2 weeksprior to initial medication, interstitial pneumonia/lung disease requiringintervention during screening, and tumor related pain requiring local treatmentduring 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 periodwithin the first 28 days of randomization

  • The researcher determined that there are other situations that are not suitable forparticipation in this study

Study Design

Total Participants: 375
Treatment Group(s): 3
Primary Treatment: Apatinib
Phase: 3
Study Start date:
June 24, 2024
Estimated Completion Date:
December 15, 2026

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing, Beijing 100000
    China

    Active - Recruiting

  • Shanghai East Hospital

    Shanghai, Shanghai 200000
    China

    Active - Recruiting

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