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

ImmuneOnco Biopharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Solid Tumor; Classic Hodgkin Lymphoma

Treatments: Drug: Tislelizumab; Drug: IMM01

Study type: Interventional

Funder types: Other

Identifiers

NCT05833984

IMM01-04

Details and patient eligibility

About

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

Full 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.

Enrollment: 309 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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;
11. Uncontrolled severe active infections.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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309 participants in 7 patient groups

Dose Escalation Part

Experimental group

Description:

Mutiple dose level cohorts in the dose escalation part

Treatment:

Drug: IMM01

Drug: Tislelizumab

Head and neck squamous cell carcinoma, nasopharyngeal carcinoma

Experimental group

Description:

Dose expansion cohort with IMM01 plus Tislelizumab

Treatment:

Drug: IMM01

Drug: Tislelizumab

Ovarian carcinoma

Experimental group

Description:

Dose expansion cohort with IMM01 plus Tislelizumab

Treatment:

Drug: IMM01

Drug: Tislelizumab

Non small cell lung carcinoma, small cell lung carcinoma

Experimental group

Description:

Dose expansion cohort with IMM01 plus Tislelizumab

Treatment:

Drug: IMM01

Drug: Tislelizumab

Hepatocellular carcinoma

Experimental group

Description:

Dose expansion cohort with IMM01 plus Tislelizumab

Treatment:

Drug: IMM01

Drug: Tislelizumab

Other solid tumors

Experimental group

Description:

Dose expansion cohort with IMM01 plus Tislelizumab

Treatment:

Drug: IMM01

Drug: Tislelizumab

Classic hodgkin lymphoma

Experimental group

Description:

Dose expansion cohort with IMM01 plus Tislelizumab

Treatment:

Drug: IMM01

Drug: Tislelizumab