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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05833984
Other study ID # IMM01-04
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date May 17, 2022
Est. completion date November 20, 2024

Study information

Verified date April 2023
Source ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Contact Zhenzhen Zong
Phone 86-21-38016387
Email zhenzhen.zong@immuneonco.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is an open-label, multicenter, phase 1b/2 trial of IMM01 (SIRPĪ± Fc) plus tislelizumab in patients with advanced solid tumors and lymphomas.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
Tislelizumab
Tislelizumab 200mg Q3W IV

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Country where clinical trial is conducted

China, 

Outcome

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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