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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05833984
• Other study ID #: IMM01-04
• Status: Recruiting
• Phase: Phase 1/Phase 2
• 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
• Study type: Interventional

Clinical Trial 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.

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.

Related Conditions & MeSH terms

• Classic Hodgkin Lymphoma
• Lymphoma
• Solid Tumor

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