Safety and Efficacy of IMM01 Plus Tislelizumab in Patients With Advanced Solid Tumors and Lymphomas
Solid Tumor, Classic Hodgkin Lymphoma
About this trial
This is an interventional treatment trial for Solid Tumor
Eligibility Criteria
Inclusion Criteria: Age ≥18 years old, male or female Life expectancy≥12 weeks; Phase 1b: Patients with advanced solid tumors diagnosed by histology or cytology, who have been failure to previous standard treatments; Phase 2: Patients with HNSCC, NPC, OC, NSCLC, SCLC, HCC, cHL and other solid tumors diagnosed by histology or cytology, who have been failure to first-line standard treatment (including PD-1/L1) at least; ECOG PS of 0 or 1; Adequate organs function, including bone marrow, hepatic, renal, cardiac, coagulation. Adverse events associated with previous anti-tumor therapy have returned to≤ grade 1(NCI CTCAE V5.0); Exclusion Criteria: Previous treatment with CD47 inhibitor/SIRPαinhibitor or fusion protein; Patients with symptomatic or progressive central nervous system (CNS) metastasis; Uncontrolled hypertension, pulmonary hypertension or unstable angina, myocardial infarction within 6 months prior to administration; a history of chronic heart failure (NYHA G3/4); severe arrhythmia; A history of arterial thrombosis, deep venous thrombosis and pulmonary embolism within 3 months prior to administration; A history of moderate or severe dyspnea, interstitial lung disease (ILD) or servre pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency; With other malignant tumors; Diseases that may cause gastrointestinal bleeding or perforation; Uncontrollable pleural, peritoneal or pericardial effusions; A history of immunodeficiency; A history of autoimmune diseases; Uncontrolled severe active infections.
Sites / Locations
- Zhejiang Cancer HospitalRecruiting
- Shandong Provincial Institute of Cancer Prevention and TreatmentRecruiting
- The Third Affiliated Hospital of Qiqihar Medical UniversityRecruiting
- Shanghai Chest HospitalRecruiting
- Henan Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Dose Escalation Part
Head and neck squamous cell carcinoma, nasopharyngeal carcinoma
Ovarian carcinoma
Non small cell lung carcinoma, small cell lung carcinoma
Hepatocellular carcinoma
Other solid tumors
Classic hodgkin lymphoma
Mutiple dose level cohorts in the dose escalation part
Dose expansion cohort with IMM01 plus Tislelizumab
Dose expansion cohort with IMM01 plus Tislelizumab
Dose expansion cohort with IMM01 plus Tislelizumab
Dose expansion cohort with IMM01 plus Tislelizumab
Dose expansion cohort with IMM01 plus Tislelizumab
Dose expansion cohort with IMM01 plus Tislelizumab