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

Phase 1

Recruiting

• Conditions: Solid Tumor; Classic Hodgkin Lymphoma
• Interventions: Drug: IMM01; Drug: Tislelizumab

• Registration Number: NCT05833984
• Lead Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

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.

Study Timeline

• Study Start: 2022-05-17
• Study First Submitted: 2023-03-27
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-18
• Last Update Submitted: 2023-04-18
• Study First Posted: 2023-04-27
• Last Update Posted: 2023-04-27
• Primary Completion: 2024-02-07
• Study Completion: 2024-11-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 309

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose Escalation Part	IMM01	Mutiple dose level cohorts in the dose escalation part
Dose Escalation Part	Tislelizumab	Mutiple dose level cohorts in the dose escalation part
Hepatocellular carcinoma	IMM01	Dose expansion cohort with IMM01 plus Tislelizumab
Hepatocellular carcinoma	Tislelizumab	Dose expansion cohort with IMM01 plus Tislelizumab
Other solid tumors	IMM01	Dose expansion cohort with IMM01 plus Tislelizumab
Head and neck squamous cell carcinoma, nasopharyngeal carcinoma	IMM01	Dose expansion cohort with IMM01 plus Tislelizumab
Head and neck squamous cell carcinoma, nasopharyngeal carcinoma	Tislelizumab	Dose expansion cohort with IMM01 plus Tislelizumab
Ovarian carcinoma	Tislelizumab	Dose expansion cohort with IMM01 plus Tislelizumab
Non small cell lung carcinoma, small cell lung carcinoma	Tislelizumab	Dose expansion cohort with IMM01 plus Tislelizumab
Classic hodgkin lymphoma	Tislelizumab	Dose expansion cohort with IMM01 plus Tislelizumab
Other solid tumors	Tislelizumab	Dose expansion cohort with IMM01 plus Tislelizumab
Non small cell lung carcinoma, small cell lung carcinoma	IMM01	Dose expansion cohort with IMM01 plus Tislelizumab
Ovarian carcinoma	IMM01	Dose expansion cohort with IMM01 plus Tislelizumab
Classic hodgkin lymphoma	IMM01	Dose expansion cohort with IMM01 plus Tislelizumab

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
AUC	up to 12 months
ADA	up to 12 months
Cmax	up to 12 months
T1/2	up to 12 months
TRAEs	up to 12 months
PFS	up to 12 months
DOR	up to 12 months
DCR	up to 12 months

Trial Locations

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