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Safety and Efficacy of IMM01 Plus Tislelizumab in Patients With Advanced Solid Tumors and Lymphomas | Clinical Trials | Clareo Health

UNKNOWNPHASE1/PHASE2

Safety and Efficacy of IMM01 Plus Tislelizumab in Patients With Advanced Solid Tumors and Lymphomas

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

NCT05833984•ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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;
+1 more criteria

Locations (5)

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, China

Key Dates

Start Date

May 17, 2022

Primary Completion Date

February 7, 2024

Completion Date

November 20, 2024

Last Updated

April 27, 2023

Enrollment

309

ESTIMATED participants

Conditions

Solid TumorClassic Hodgkin Lymphoma

Interventions

IMM01

DRUG

Tislelizumab

DRUG

Contacts

Zhenzhen Zong

CONTACT

86-21-38016387 zhenzhen.zong@immuneonco.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 27, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy of IMM01 Plus Tislelizumab in Patients With Advanced Solid Tumors and Lymphomas

Inclusion Criteria

Exclusion Criteria

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