Solid Tumor Clinical Trial
Official title:
A Phase 1b/2 Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, and Efficacy of IMM01 Plus Tislelizumab in Patients With Advanced Solid Tumors and Lymphomas
This is an open-label, multicenter, phase 1b/2 trial of IMM01 (SIRPĪ± Fc) plus tislelizumab in patients with advanced solid tumors and lymphomas.
Status | Recruiting |
Enrollment | 309 |
Est. completion date | November 20, 2024 |
Est. primary completion date | February 7, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age =18 years old, male or female 2. Life expectancy=12 weeks; 3. 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; 4. ECOG PS of 0 or 1; 5. Adequate organs function, including bone marrow, hepatic, renal, cardiac, coagulation. 6. Adverse events associated with previous anti-tumor therapy have returned to= grade 1(NCI CTCAE V5.0); Exclusion Criteria: 1. Previous treatment with CD47 inhibitor/SIRPainhibitor or fusion protein; 2. Patients with symptomatic or progressive central nervous system (CNS) metastasis; 3. 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; 4. A history of arterial thrombosis, deep venous thrombosis and pulmonary embolism within 3 months prior to administration; 5. A history of moderate or severe dyspnea, interstitial lung disease (ILD) or servre pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency; 6. With other malignant tumors; 7. Diseases that may cause gastrointestinal bleeding or perforation; 8. Uncontrollable pleural, peritoneal or pericardial effusions; 9. A history of immunodeficiency; 10. A history of autoimmune diseases; 11. Uncontrolled severe active infections. |
Country | Name | City | State |
---|---|---|---|
China | Zhejiang Cancer Hospital | Hangzhou | |
China | Shandong Provincial Institute of Cancer Prevention and Treatment | Jinan | |
China | The Third Affiliated Hospital of Qiqihar Medical University | Qiqihar | |
China | Shanghai Chest Hospital | Shanghai | |
China | Henan Cancer Hospital | Zhengzhou |
Lead Sponsor | Collaborator |
---|---|
ImmuneOnco Biopharmaceuticals (Shanghai) Inc. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose-limiting toxicity in dose escalation part | DLT observation 21 days | ||
Primary | MTD/RP2D in dose escalation part | DLT observation 21 days | ||
Primary | ORR in dose expansion part | up to 12 months | ||
Secondary | TRAEs | up to 12 months | ||
Secondary | PFS | up to 12 months | ||
Secondary | DOR | up to 12 months | ||
Secondary | DCR | up to 12 months | ||
Secondary | Cmax | up to 12 months | ||
Secondary | T1/2 | up to 12 months | ||
Secondary | AUC | up to 12 months | ||
Secondary | ADA | up to 12 months |
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