Trial Title:
Safety and Efficacy of IMM01 Plus Tislelizumab in Patients With Advanced Solid Tumors and Lymphomas
NCT ID:
NCT05833984
Condition:
Solid Tumor
Classic Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Tislelizumab
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
IMM01
Description:
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.
Arm group label:
Classic hodgkin lymphoma
Arm group label:
Dose Escalation Part
Arm group label:
Head and neck squamous cell carcinoma, nasopharyngeal carcinoma
Arm group label:
Hepatocellular carcinoma
Arm group label:
Non small cell lung carcinoma, small cell lung carcinoma
Arm group label:
Other solid tumors
Arm group label:
Ovarian carcinoma
Other name:
SIRPα Fc
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Tislelizumab 200mg Q3W IV
Arm group label:
Classic hodgkin lymphoma
Arm group label:
Dose Escalation Part
Arm group label:
Head and neck squamous cell carcinoma, nasopharyngeal carcinoma
Arm group label:
Hepatocellular carcinoma
Arm group label:
Non small cell lung carcinoma, small cell lung carcinoma
Arm group label:
Other solid tumors
Arm group label:
Ovarian carcinoma
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Xuan Zheng
Email:
xuan.zheng@immuneonco.com
Investigator:
Last name:
Zhengbo Song, M.D.
Email:
Principal Investigator
Facility:
Name:
Shandong Provincial Institute of Cancer Prevention and Treatment
Address:
City:
Jinan
Country:
China
Status:
Recruiting
Contact:
Last name:
Xuan Zheng
Email:
xuan.zheng@immuneonco.com
Investigator:
Last name:
Yan Zhang, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Hui Zhu, M.D.
Email:
Principal Investigator
Facility:
Name:
The Third Affiliated Hospital of Qiqihar Medical University
Address:
City:
Qiqihar
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiaqi Yang
Email:
jiaqi.yang@immuneonco.com
Investigator:
Last name:
Xu Tong, M.D.
Email:
Principal Investigator
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Xuan Zheng
Email:
xuan.zheng@immuneonco.com
Investigator:
Last name:
Shun Lu, Ph.D.
Email:
Principal Investigator
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Rongqiang Sun
Email:
rongqiang.sun@immuneonco.com
Investigator:
Last name:
Yanqiu Zhao, M.D.
Email:
Principal Investigator
Start date:
May 17, 2022
Completion date:
November 20, 2024
Lead sponsor:
Agency:
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Agency class:
Other
Source:
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05833984
