Classic Hodgkin Lymphoma, Solid Tumor
Conditions
Brief summary
This is an open-label, multicenter, phase 1b/2 trial of IMM01 (SIRPα Fc) plus tislelizumab in patients with advanced solid tumors and lymphomas.
Detailed description
This open-label, multicenter, phase 1b/2 trial is conducted to evaluate the safety, tolerability and preliminary activity in patients with advanced solid tumors and lymphomas. This trial includes two parts: the phase 1b dose escalation part and the phase 2 dose expansion part. In the dose escalation part with a standard 3+3 design, IMM01 (1.0, 1.5, 2.0 mg/kg) was administered once a week and tislelizumab (200mg) was administered once every 3 weeks. In the dose expansion part, IMM01 (the dose determined in the dose escalation part) was administered once a week and tislelizumab (200mg) was administered once every 3 weeks. And the cohorts includes HNSCC, NSCLC, SCLC, R/R cHL and others.
Interventions
DRUGIMM01
IMM01 (1.0, 1.5, 2.0 mg/kg) QW IV in the dose escalation part. IMM01 (dose determined in the dose escalation part) QW IV in the dose expansion part.
DRUGTislelizumab
Tislelizumab 200mg Q3W IV
Sponsors
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/SIRPαinhibitor 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity in dose escalation part | DLT observation 21 days |
| MTD/RP2D in dose escalation part | DLT observation 21 days |
| ORR in dose expansion part | up to 12 months |
Secondary
| Measure | Time frame |
|---|---|
| DCR | up to 12 months |
| Cmax | up to 12 months |
| TRAEs | up to 12 months |
| AUC | up to 12 months |
| ADA | up to 12 months |
| T1/2 | up to 12 months |
| PFS | up to 12 months |
| DOR | up to 12 months |
Countries
China
Contacts
Primary ContactZhenzhen Zong
Outcome results
None listed