A LM-302 Combination With Other Anti-Tumor Therapies Phase ll Study
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.
LaNova Medicines Zhejiang Co., Ltd.
276 participants
Jul 27, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria9
- Subjects 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.
- Subjects 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.
- At least one measurable lesion.
- Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose.
- Subjects who are able to communicate well with investigators and understand and adhere to the requirements of this study.
Exclusion Criteria28
- Subjects with known HER2-positive gastric cancer/adenocarcinoma of the gastroesophageal junction
- Subjects have participated in any other clinical trial within 28 days prior to 1st dosing of investigational medicinal product (IMP).
- Subjects 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.
- Subjects with uncontrolled pain.
- Subjects with symptomatic/active central nervous system(CNS)metastases.
- Subject who have uncontrollable third space effusion.
- Subjects with known hypersensitivity to antibody therapy.
- Subjects have treated with the same target.
- Subjects 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.
- Subjects with current or previous interstitial lung diseases or pneumonia requiring oral or intravenous glucocorticoids for adjuvant therapy.
- Subjects 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.
- Subjects who received major surgery or interventional treatment within28 days prior to the first dosing of IMP.
- Subjects who have other cancers, other than the one treated in this trial, within 2 years prior to screening.
- Subjects who have severe cardiovascular disease.
- Subjects who have uncontrolled or severe illness.
- Subjects who take systemic corticosteroids (\> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of IMP.
- Subjects with a known history of autoimmune diseases.
- Subjects who have a history of immunodeficiency disease.
- Subjects 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.
- Subject who have a known psychiatric diseases or disorders that may affect compliance with the trial.
- Subject who is judged as not eligible to participate in this study by the investigator.
Interventions
Q2W/Q3W,Administered intravenously
Q2W/Q3W,Administered intravenously
BID,Oral Administration
BID,Oral Administration
Q4W,Administered intravenously
QD,Oral Administration
Q4W,Administered intravenously
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05934331