Clinical trial NCT06351020: LM-302 for the Treatment of Subjects With Claudin18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma.
Official 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Locally Advanced or Metastatic GC and GCJ Adenocarcinoma
Lead sponsor: LaNova Medicines Limited
Sponsor class: INDUSTRY
First posted: 2024-04-08
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: experimental arm:LM-302 control arm:Apatinib or Irinotecan
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: up to 42 months
measure: Progression Free Survival (PFS)
timeFrame: up to 42 months
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: From start of treatment to date of documented disease progression, up to approximately 42 months
measure: Duration of response (DoR)
timeFrame: 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
measure: Disease control rate (DCR)
timeFrame: From start of treatment to date of documented disease progression, up to approximately 42 months
measure: AE and SAE
timeFrame: From signing the ICF until 28 days after EOT or accept other anti-cancer therapy,up to 40 days after last study dose
measure: Evaluate the immunogenicity of LM-302
timeFrame: up to 42 months
measure: Evaluation of pharmacokinetic characteristics of LM-302
timeFrame: up to 42 months
measure: Evaluation of pharmacokinetic characteristics of LM-302
timeFrame: up to 42 months
measure: Evaluation of pharmacokinetic characteristics of LM-302
timeFrame: up to 42 months
measure: Evaluation of pharmacokinetic characteristics of total antibody
timeFrame: up to 42 months
measure: Evaluation of pharmacokinetic characteristics of total antibody
timeFrame: up to 42 months
measure: Evaluation of pharmacokinetic characteristics of total antibody
timeFrame: up to 42 months
measure: Evaluation of pharmacokinetic characteristics of MMAE
timeFrame: up to 42 months
measure: Evaluation of pharmacokinetic characteristics of MMAE
timeFrame: up to 42 months
measure: Evaluation of pharmacokinetic characteristics of MMAE
timeFrame: up to 42 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
Study officials:
affiliation: Peking Union Medical College Hospital
name: Chunmei Bai
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai East Hospital
name: Jin Li
role: PRINCIPAL_INVESTIGATOR
References: