Locally Advanced or Metastatic GC and GCJ AdenocarcinomaPhase 3NCT06351020
LM-302 for the Treatment of Subjects With Claudin18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma.
A Phase 3 study testing LM-302, Apatinib and Irinotecan in people with Locally Advanced or Metastatic GC and GCJ Adenocarcinoma, run by LaNova Medicines Zhejiang Co., Ltd. at 2 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Locally Advanced or Metastatic GC and GCJ Adenocarcinoma
- What is being tested?
- LM-302, Apatinib and Irinotecan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 387 participants
- Where
- 2 sitesChina
- Study dates
- 24 Jun 2024to 15 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- ECOG: 0-1
- Expected survival ≥12 weeks;
- Good blood reserve and liver, kidney and coagulation function
- Willing to provide informed consent for study participation.
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200000
About this study
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.
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
- Being tested
- LM-302, Apatinib, Irinotecan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LM-302Drug
LM-302 intravenous-injection every 2 weeks on Day 1 of each 14-day cycle
ApatinibDrug
The subjects will receive Apatinib orally,qd
IrinotecanDrug
The subjects will receive Irinotecan intravenous-injection,every 2 weeks on Day 1 of each 14-day cycle
| Study group | Role | What they receive |
|---|---|---|
| LM-302 | Experimental | Patients will accept LM-302 monotherapy Receives: Drug: LM-302 |
| Physician's choice Apatinib or Irinotecan | Active comparator | Patients will accept Apatinib or Irinotecan monotherapy Receives: Drug: Apatinib; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS was defined defined as the time from date of randomization until death from any cause.
Measured: 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
Measured: up to 42 months
Secondary outcomes (14)
Objective response rate (ORR)
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.
Measured: From start of treatment to date of documented disease progression, up to approximately 42 months
Duration of response (DoR)
defined time from the initial response (CR or PR) until documented tumor progression or death from any cause and based on Investigator assessment.
Measured: 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)
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.
Measured: From start of treatment to date of documented disease progression, up to approximately 42 months
AE and SAE
Adverse events will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0
Measured: 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
Anti-drug antibody (ADA) will be detected, the titer of ADA will be evaluated using the validated assay.
Measured: up to 42 months
Evaluation of pharmacokinetic characteristics of LM-302
Peak Plasma Concentration (Cmax) will be evaluated using PopPK model and simulation.
Measured: up to 42 months
Evaluation of pharmacokinetic characteristics of LM-302
Area under the plasma concentration versus time curve (AUC) will be evaluated using PopPK model and simulation.
Measured: up to 42 months
Evaluation of pharmacokinetic characteristics of LM-302
Trough concentration will be evaluated using PopPK model and simulation.
Measured: up to 42 months
Evaluation of pharmacokinetic characteristics of total antibody
Peak Plasma Concentration (Cmax) will be evaluated using PopPK model and simulation.
Measured: up to 42 months
Evaluation of pharmacokinetic characteristics of total antibody
Area under the plasma concentration versus time curve (AUC) will be evaluated using PopPK model and simulation.
Measured: up to 42 months
Evaluation of pharmacokinetic characteristics of total antibody
Trough concentration will be evaluated using PopPK model and simulation.
Measured: up to 42 months
Evaluation of pharmacokinetic characteristics of MMAE
Peak Plasma Concentration (Cmax) will be evaluated using PopPK model and simulation.
Measured: up to 42 months
Evaluation of pharmacokinetic characteristics of MMAE
Area under the plasma concentration versus time curve (AUC) will be evaluated using PopPK model and simulation.
Measured: up to 42 months
Evaluation of pharmacokinetic characteristics of MMAE
Trough concentration will be evaluated using PopPK model and simulation.
Measured: up to 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start24 Jun 2024
- Primary completion10 Nov 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic GC and GCJ AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- experimental arm:LM-302 control arm:Apatinib or Irinotecan
- Masking
- None (open label)
- Enrolment
- 387 participants (actual)
Sponsor and investigators
- Lead sponsor
- LaNova Medicines Zhejiang Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chunmei Bai, Principal investigator, Peking Union Medical College HospitalJin Li, Principal investigator, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351020
- Sponsor's protocol ID
- LM302-03-101
- Status last verified
- Feb 2026
- First submitted
- 15 Mar 2024
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06351020
- Acronym / sponsor ID
- LM302-03-101
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 387 participants (actual)
- Lead sponsor
- LaNova Medicines Zhejiang Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- experimental arm:LM-302 control arm:Apatinib or Irinotecan
| Arm | Type | Receives |
|---|---|---|
| LM-302 | Experimental | Drug: LM-302Patients will accept LM-302 monotherapy |
| Physician's choice Apatinib or Irinotecan | Active comparator | Drug: Apatinib, Drug: IrinotecanPatients will accept Apatinib or Irinotecan monotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LM-302LM-302 intravenous-injection every 2 weeks on Day 1 of each 14-day cycle | Drug | LM-302 |
| ApatinibThe subjects will receive Apatinib orally,qd | Drug | Physician's choice Apatinib or Irinotecan |
| IrinotecanThe subjects will receive Irinotecan intravenous-injection,every 2 weeks on Day 1 of each 14-day cycle | Drug | Physician's choice Apatinib or Irinotecan |
Primary outcome
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.
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
14 secondary outcomes
Objective response rate (ORR)
Time frame: From start of treatment to date of documented disease progression, up to approximately 42 months
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
Disease control rate (DCR)
Time frame: From start of treatment to date of documented disease progression, up to approximately 42 months
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
Evaluate the immunogenicity of LM-302
Time frame: up to 42 months
Evaluation of pharmacokinetic characteristics of LM-302
Time frame: up to 42 months
Evaluation of pharmacokinetic characteristics of LM-302
Time frame: up to 42 months
Evaluation of pharmacokinetic characteristics of LM-302
Time frame: up to 42 months
Evaluation of pharmacokinetic characteristics of total antibody
Time frame: up to 42 months
Evaluation of pharmacokinetic characteristics of total antibody
Time frame: up to 42 months
Evaluation of pharmacokinetic characteristics of total antibody
Time frame: up to 42 months
Evaluation of pharmacokinetic characteristics of MMAE
Time frame: up to 42 months
Evaluation of pharmacokinetic characteristics of MMAE
Time frame: up to 42 months
Evaluation of pharmacokinetic characteristics of MMAE
Time frame: up to 42 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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Locally Advanced or Metastatic GC and GCJ Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunmei Bai principal investigator
Peking Union Medical College Hospital
Jin Li principal investigator
Shanghai East Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LM-302, Apatinib and Irinotecan in people with Locally Advanced or Metastatic GC and GCJ Adenocarcinoma, run by LaNova Medicines Zhejiang Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: up to 42 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.