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Malignant Neoplasms of Digestive OrgansPhase 2NCT05934331

A LM-302 Combination With Other Anti-Tumor Therapies Phase ll Study

A Phase 2 study testing LM-302, Toripalimab and Capecitabine in people with Malignant Neoplasms of Digestive Organs, run by LaNova Medicines Zhejiang Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is to evaluate the efficacy of the LM-302 Combination With Other Therapies in patients with CLDN18.2-positive Advanced Digestive Tract Tumor. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Malignant Neoplasms of Digestive Organs
What is being tested?
LM-302, Toripalimab and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
632 participants
Where
1 siteChina
Study dates
27 Jul 2023to 6 Aug 2031
Phase
Phase 2
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

  • Participants who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
  • Aged 18-80 years old (including boundary values) .
  • Eastern Cooperative Oncology Group (ECOG) performance status of0-1.
  • Life expectancy ≥ 3 months.
  • Participants with advanced gastrointestinal tumors diagnosed histologically and/or cytologically and who have failed or are intolerant to prior standard first-line therapy (imaging confirmation required)
  • CLDN18.2-positive subjects.
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  • At least one measurable lesion.
  • Participants must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose.
  • Participants who are able to communicate well with investigators and understand and adhere to the requirements of this study.

Who cannot join

  • Participants with known HER2-positive gastric cancer/adenocarcinoma of the gastroesophageal junction
  • Participants have participated in any other clinical trial within 28 days prior to 1st dosing of investigational medicinal product (IMP).
  • Participants with anti-tumor treatment within 21 days prior to 1st dosing of IMP.
  • Previous immunotherapy and grade ≥3 irAE or grade ≥2 immune-related myocarditis. (for cohorts treated with combination PD-1).
  • Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
  • Present peripheral sensory or motor neuropathy ≥ grade 2.
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  • Participants with uncontrolled pain.
  • Participants with symptomatic/active central nervous system(CNS)metastases.
  • Participants who have uncontrollable third space effusion.
  • Participants with known hypersensitivity to antibody therapy.
  • Participants have treated with the same target.
  • Participants have received Strong inhibitor/strong inducer of CYP3A4 within 14 days prior to first dose.
  • Use of any live vaccines within 28 days prior to 1st dosing of IMP.
  • Participants with current or previous interstitial lung diseases or pneumonia requiring oral or intravenous glucocorticoids for adjuvant therapy.
  • Participants on anticoagulants, such as heparin and vitamin K antagonists.
  • Clinically uncontrollable persistent recurrent vomiting.
  • Uncontrollable/severe gastrointestinal bleeding, ulceration or diarrhea within 28 days prior to first dose of IMP.
  • Participants who received major surgery or interventional treatment within28 days prior to the first dosing of IMP.
  • Participants who have other cancers, other than the one treated in this trial, within 2 years prior to screening.
  • Participants who have severe cardiovascular disease.
  • Participants who have uncontrolled or severe illness.
  • Participants who take systemic corticosteroids (> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of IMP.
  • Participants with a known history of autoimmune diseases.
  • Participants who have a history of immunodeficiency disease.
  • Participants with HIV infection, active HBV or HCV infection.
  • Child-bearing potential female who have positive results in pregnancy test within 7 days before the first dose or are lactating.
  • Participants who have a known psychiatric diseases or disorders that may affect compliance with the trial.
  • Participants who is judged as not eligible to participate in this study by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alex Yuan contact

021-68889618

AlexYuan@Lanovamed.com

Paul Kong contact

021-68889618

paulkong@lanovamed.com

China1 site, 1 recruiting

  • Shanghai East Hospital

    Shanghai

    Jin Li

    Recruiting

Other trials in China

About this study

Official title: An Open-label, Multicenter Phase II Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of the LM-302 Combination With Other Anti-tumor Treatment in Subjects With CLDN18.2-positive Advanced Gastro-Intestinal Cancer.

This study is to evaluate the efficacy of the LM-302 Combination With Other Therapies in patients with CLDN18.2-positive Advanced Digestive Tract Tumor.

Being tested
LM-302, Toripalimab, Capecitabine, Tegafur, Gimeracil and Oteracil Potassium Capsules, Nivolumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LM-302Drug

    Q2W/Q3W，Administered intravenously

  • ToripalimabDrug

    Q2W/Q3W,Administered intravenously

  • CapecitabineDrug

    BID,Oral Administration

  • Tegafur, Gimeracil and Oteracil Potassium CapsulesDrug

    BID,Oral Administration

  • NivolumabDrug

    Q4W,Administered intravenously

  • ApatinibDrug

    QD,Oral Administration

  • GemcitabineDrug

    Q4W,Administered intravenously

  • TislelizumabDrug

    Q2W Administered intravenously

  • AnlotinibDrug

    QD,Oral Administration

  • BenmelstobartDrug

    Q4W Administered intravenously

  • LM-302Drug

    Q2W Administered intravenously

Study groups in NCT05934331
Study groupRoleWhat they receive
LM-302 in combination with ToripalimabExperimentalNot described
Receives: Drug: LM-302; Drug: Toripalimab
LM-302 in combination with other therapiesExperimentalNot described
Receives: Drug: LM-302; Drug: Toripalimab; Drug: Capecitabine; Drug: Tegafur, Gimeracil and Oteracil Potassium Capsules; Drug: Nivolumab; Drug: Apatinib; Drug: Gemcitabine; Drug: Tislelizumab; Drug: Anlotinib; Drug: Benmelstobart
LM-302 monotherapyExperimentalNot described
Receives: Drug: LM-302

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS

    Progression free survival according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

    Measured: 112 weeks

Secondary outcomes (36)

  1. ORR

    Objective response rate (ORR)

    Measured: 112 weeks

  2. DOR

    Duration of response (DOR)

    Measured: 112 weeks

  3. DCR

    Disease control rate (DCR = CR + PR + SD)

    Measured: 112 weeks

  4. OS

    Overall survival (OS)

    Measured: 112 weeks

  5. AEs

    Incidence of adverse events

    Measured: 112 weeks

  6. SAEs

    Incidence of serious adverse events

    Measured: 112 weeks

  7. Temperatures

    Temperatures

    Measured: 112 weeks

  8. Pulse in BPM

    Beat per Minute

    Measured: 112 weeks

  9. Blood Pressure

    Blood Pressure in mmHg

    Measured: 112 weeks

  10. Weight

    Weight in Kg

    Measured: 112 weeks

  11. Height

    Height in centimeter

    Measured: 112 weeks

  12. Blood Routine examination

    Laboratory tests-Blood Routine examination

    Measured: 112 weeks

  13. Urine Routine test

    Laboratory tests-Urine Routine test

    Measured: 112 weeks

  14. Blood biochemistry

    Laboratory tests-Blood biochemistry

    Measured: 112 weeks

  15. Coagulation function

    Laboratory tests- Coagulation function

    Measured: 112 weeks

  16. LVEF

    Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage

    Measured: 112 weeks

  17. HR

    12-lead electrocardiogram (ECG) in HR

    Measured: 112 weeks

  18. RR

    12-lead electrocardiogram (ECG) in RR

    Measured: 112 weeks

  19. PR

    12-lead electrocardiogram (ECG) in PR

    Measured: 112 weeks

  20. QRS

    12-lead electrocardiogram (ECG) in QRS

    Measured: 112 weeks

  21. QT

    12-lead electrocardiogram (ECG) in QT

    Measured: 112 weeks

  22. QTcF

    12-lead electrocardiogram (ECG) in QTcF

    Measured: 112 weeks

  23. ECOG score

    Eastern Cooperative Oncology Group score

    Measured: 112 weeks

  24. PK Parameter:Cmax

    Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)

    Measured: 112 weeks

  25. PK Parameter：Tmax

    PK Parameter:Time of Maximum Observed Concentration (Tmax)

    Measured: 112 weeks

  26. PK Parameter: AUC

    PK Parameter: Area Under the Concentration-time Curve(AUC)

    Measured: 112 weeks

  27. PK Parameter: Cmax,ss

    PK Parameter: Steady State Maximum Concentration(Cmax,ss)

    Measured: 112 weeks

  28. PK Parameter: Cmin,ss

    PK Parameter: Steady State Minimum Concentration(Cmin,ss)

    Measured: 112 weeks

  29. PK Parameter: CLss

    PK Parameter: Systemic Clearance at Steady State (CLss)

    Measured: 112 weeks

  30. PK Parameter:Rac

    PK Parameter: Accumulation Ratio (Rac)

    Measured: 112 weeks

  31. PK Parameter: t1/2

    PK Parameter: Elimination Half-life (t1/2)

    Measured: 112 weeks

  32. PK Parameter: Vss

    PK Parameter: Volume of Distribution at Steady-State (Vss)

    Measured: 112 weeks

  33. PK Parameter: DF

    PK Parameter: Degree of Fluctuation (DF)

    Measured: 112 weeks

  34. Immunogenicity of LM-302

    Anti-Drug antibody and Nab (if neccessary) will be tested.

    Measured: 112 weeks

  35. Biomarker correlation

    For the detection of CLDN18.2 and PD-L1

    Measured: 112 weeks

  36. AE/SAE

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Measured: 112 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2023
  2. Study start27 Jul 2023
  3. Primary completion6 Aug 2031 (estimated)
  4. Study completion6 Aug 2031 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
632 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05934331
Sponsor's protocol ID
LM302-02-201
Status last verified
Oct 2026
First submitted
19 Jun 2023
Last updated
19 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LM-302, Toripalimab and Capecitabine in people with Malignant Neoplasms of Digestive Organs, run by LaNova Medicines Zhejiang Co., Ltd. at 1 site 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 9 inclusion and 28 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: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact Alex Yuan (021-68889618, AlexYuan@Lanovamed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: 112 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05934331.

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 19 Oct 2026.

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