Safety and Efficacy of IMM01 Plus Tislelizumab in Patients With Advanced Solid Tumors and Lymphomas
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dose Escalation Part Mutiple dose level cohorts in the dose escalation part |
Drug: IMM01
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.
Other Names:
Drug: Tislelizumab
Tislelizumab 200mg Q3W IV
|
| Experimental: Head and neck squamous cell carcinoma, nasopharyngeal carcinoma Dose expansion cohort with IMM01 plus Tislelizumab |
Drug: IMM01
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.
Other Names:
Drug: Tislelizumab
Tislelizumab 200mg Q3W IV
|
| Experimental: Ovarian carcinoma Dose expansion cohort with IMM01 plus Tislelizumab |
Drug: IMM01
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.
Other Names:
Drug: Tislelizumab
Tislelizumab 200mg Q3W IV
|
| Experimental: Non small cell lung carcinoma, small cell lung carcinoma Dose expansion cohort with IMM01 plus Tislelizumab |
Drug: IMM01
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.
Other Names:
Drug: Tislelizumab
Tislelizumab 200mg Q3W IV
|
| Experimental: Hepatocellular carcinoma Dose expansion cohort with IMM01 plus Tislelizumab |
Drug: IMM01
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.
Other Names:
Drug: Tislelizumab
Tislelizumab 200mg Q3W IV
|
| Experimental: Other solid tumors Dose expansion cohort with IMM01 plus Tislelizumab |
Drug: IMM01
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.
Other Names:
Drug: Tislelizumab
Tislelizumab 200mg Q3W IV
|
| Experimental: Classic hodgkin lymphoma Dose expansion cohort with IMM01 plus Tislelizumab |
Drug: IMM01
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.
Other Names:
Drug: Tislelizumab
Tislelizumab 200mg Q3W IV
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- TRAEs [up to 12 months]
- PFS [up to 12 months]
- DOR [up to 12 months]
- DCR [up to 12 months]
- Cmax [up to 12 months]
- T1/2 [up to 12 months]
- AUC [up to 12 months]
- ADA [up to 12 months]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhejiang Cancer Hospital | Hangzhou | China | ||
| 2 | Shandong Provincial Institute of Cancer Prevention and Treatment | Jinan | China | ||
| 3 | The Third Affiliated Hospital of Qiqihar Medical University | Qiqihar | China | ||
| 4 | Shanghai Chest Hospital | Shanghai | China | ||
| 5 | Henan Cancer Hospital | Zhengzhou | China |
Sponsors and Collaborators
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IMM01-04