Phase
Condition
Gastric Cancer
Pancreatic Cancer
Pancreatitis
Treatment
Apatinib
LM-302
Toripalimab
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects who are willing to participate in the study and sign the informed consentform (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/orcytologically and who have failed or are intolerant to prior standard first-linetherapy (imaging confirmation required)
CLDN18.2-positive subjects.
At least one measurable lesion.
Subjects must show appropriate organ and marrow function in laboratory examinationswithin 7 days prior to the first dose.
Subjects who are able to communicate well with investigators and understand andadhere to the requirements of this study.
Exclusion
Exclusion Criteria:
Subjects with known HER2-positive gastric cancer/adenocarcinoma of thegastroesophageal junction
Subjects have participated in any other clinical trial within 28 days prior to 1stdosing 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 1of 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 daysprior 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 requiringoral 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 28days prior to first dose of IMP.
Subjects who received major surgery or interventional treatment within28 days priorto the first dosing of IMP.
Subjects who have other cancers, other than the one treated in this trial, within 2years 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) orother systemic immunosuppressive medications within 2 weeks prior to the firstdosing 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 7days before the first dose or are lactating.
Subject who have a known psychiatric diseases or disorders that may affectcompliance with the trial.
Subject who is judged as not eligible to participate in this study by theinvestigator.
Study Design
Connect with a study center
Shanghai East Hospital
Shanghai,
ChinaSite Not Available
Shanghai East Hospital
Shanghai 1796236,
ChinaActive - Recruiting

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