Combining LM-302 with Toripalimab for advanced gastrointestinal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II clinical trial evaluates the effectiveness, safety, and tolerability of the combination of LM-302 and Toripalimab in patients with advanced gastrointestinal cancers that are positive for CLDN18.2. The study aims to assess the primary efficacy of this treatment regimen while also exploring the relationship between CLDN18.2 and PD-L1 expression levels and their impact on tumor response. Participants will be monitored for measurable lesions and overall health to ensure appropriate organ function. The trial is open-label and multicenter, allowing for a diverse patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participants who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
2. Aged 18-80 years old (including boundary values) .
3. Eastern Cooperative Oncology Group (ECOG) performance status of0-1.
4. Life expectancy ≥ 3 months.
5. 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)
6. CLDN18.2-positive subjects.
7. At least one measurable lesion.
8. Participants must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose.
9. Participants who are able to communicate well with investigators and understand and adhere to the requirements of this study.

Exclusion Criteria:

1. Participants with known HER2-positive gastric cancer/adenocarcinoma of the gastroesophageal junction
2. Participants have participated in any other clinical trial within 28 days prior to 1st dosing of investigational medicinal product (IMP).
3. Participants with anti-tumor treatment within 21 days prior to 1st dosing of IMP.
4. Previous immunotherapy and grade ≥3 irAE or grade ≥2 immune-related myocarditis. (for cohorts treated with combination PD-1).
5. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
6. Present peripheral sensory or motor neuropathy ≥ grade 2.
7. Participants with uncontrolled pain.
8. Participants with symptomatic/active central nervous system(CNS)metastases.
9. Participants who have uncontrollable third space effusion.
10. Participants with known hypersensitivity to antibody therapy.
11. Participants have treated with the same target.
12. Participants have received Strong inhibitor/strong inducer of CYP3A4 within 14 days prior to first dose.
13. Use of any live vaccines within 28 days prior to 1st dosing of IMP.
14. Participants with current or previous interstitial lung diseases or pneumonia requiring oral or intravenous glucocorticoids for adjuvant therapy.
15. Participants on anticoagulants, such as heparin and vitamin K antagonists.
16. Clinically uncontrollable persistent recurrent vomiting.
17. Uncontrollable/severe gastrointestinal bleeding, ulceration or diarrhea within 28 days prior to first dose of IMP.
18. Participants who received major surgery or interventional treatment within28 days prior to the first dosing of IMP.
19. Participants who have other cancers, other than the one treated in this trial, within 2 years prior to screening.
20. Participants who have severe cardiovascular disease.
21. Participants who have uncontrolled or severe illness.
22. 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.
23. Participants with a known history of autoimmune diseases.
24. Participants who have a history of immunodeficiency disease.
25. Participants with HIV infection, active HBV or HCV infection.
26. Child-bearing potential female who have positive results in pregnancy test within 7 days before the first dose or are lactating.
27. Participants who have a known psychiatric diseases or disorders that may affect compliance with the trial.
28. Participants who is judged as not eligible to participate in this study by the investigator.

Where it's running

• Shanghai East Hospital
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Jin Li — Shanghai East Hospital
• Study coordinator: Alex Yuan
• Email: AlexYuan@Lanovamed.com
• Phone: 021-68889618

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• LM-168 with other cancer treatments in advanced solid tumors

  This trial tests LM-168 in combination with other cancer therapies to see if it is safe and tolerable and to check early signs of activity in adults with advanced solid tumors.

  Recruiting Phase 2 LaNova Medicines Limited · Beijing, Beijing Municipality · NCT07669415

• Phase II LM-24C5 treatment for CEACAM5-positive advanced solid tumors

  This trial tests whether giving LM-24C5 together with other therapies is safe and helps adults (18–80) who have CEACAM5-positive advanced solid tumors.

  Recruiting Phase 2 LaNova Medicines Limited · Fuzhou, Fujian and 1 other locations · NCT07387081

• LM-108 plus toripalimab versus paclitaxel for CCR8-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma

  This trial tests whether adding LM-108 (an anti-CCR8 antibody) to the PD-1 blocker toripalimab works better than paclitaxel for adults with CCR8-positive advanced or metastatic gastric or GEJ adenocarcinoma after first-line therapy.

  Recruiting Phase 3 LaNova Medicines Limited · Beijing, Beijing Municipality · NCT07362186

• LM-350 treatment for advanced solid tumors

  This trial will test LM-350, an experimental injectable drug, in adults with advanced solid tumors who have not responded to or cannot receive standard treatments.

  Recruiting at 3 sites Phase 1/2 LaNova Medicines Limited · Wollongong, New South Wales and 3 other locations · NCT07112222

• LM-168 alone or combined with toripalimab for advanced solid tumors

  This trial tests whether LM-168, given alone or together with the immunotherapy toripalimab, can shrink tumors or control disease in adults with advanced solid tumors.

  Recruiting at 5 sites Phase 1/2 LaNova Medicines Limited · Ryde, New South Wales and 5 other locations · NCT06868199

• LM-2417 for advanced solid tumors (Phase 1/2)

  This trial will test the safety and best dose of LM-2417 alone or combined with other cancer drugs in adults with advanced solid tumors who have exhausted or cannot tolerate standard therapies.

  Recruiting Phase 1/2 LaNova Medicines Limited · Shanghai, Shanghai Municipality · NCT06682780

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.