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

Primary Purpose

Solid Tumor, Classic Hodgkin Lymphoma

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
IMM01
Tislelizumab
Sponsored by
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥18 years old, male or female Life expectancy≥12 weeks; 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; ECOG PS of 0 or 1; Adequate organs function, including bone marrow, hepatic, renal, cardiac, coagulation. Adverse events associated with previous anti-tumor therapy have returned to≤ grade 1(NCI CTCAE V5.0); Exclusion Criteria: Previous treatment with CD47 inhibitor/SIRPαinhibitor or fusion protein; Patients with symptomatic or progressive central nervous system (CNS) metastasis; 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; A history of arterial thrombosis, deep venous thrombosis and pulmonary embolism within 3 months prior to administration; A history of moderate or severe dyspnea, interstitial lung disease (ILD) or servre pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency; With other malignant tumors; Diseases that may cause gastrointestinal bleeding or perforation; Uncontrollable pleural, peritoneal or pericardial effusions; A history of immunodeficiency; A history of autoimmune diseases; Uncontrolled severe active infections.

Sites / Locations

  • Zhejiang Cancer HospitalRecruiting
  • Shandong Provincial Institute of Cancer Prevention and TreatmentRecruiting
  • The Third Affiliated Hospital of Qiqihar Medical UniversityRecruiting
  • Shanghai Chest HospitalRecruiting
  • Henan Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Dose Escalation Part

Head and neck squamous cell carcinoma, nasopharyngeal carcinoma

Ovarian carcinoma

Non small cell lung carcinoma, small cell lung carcinoma

Hepatocellular carcinoma

Other solid tumors

Classic hodgkin lymphoma

Arm Description

Mutiple dose level cohorts in the dose escalation part

Dose expansion cohort with IMM01 plus Tislelizumab

Dose expansion cohort with IMM01 plus Tislelizumab

Dose expansion cohort with IMM01 plus Tislelizumab

Dose expansion cohort with IMM01 plus Tislelizumab

Dose expansion cohort with IMM01 plus Tislelizumab

Dose expansion cohort with IMM01 plus Tislelizumab

Outcomes

Primary Outcome Measures

Dose-limiting toxicity in dose escalation part
MTD/RP2D in dose escalation part
ORR in dose expansion part

Secondary Outcome Measures

TRAEs
PFS
DOR
DCR
Cmax
T1/2
AUC
ADA

Full Information

First Posted
March 27, 2023
Last Updated
April 18, 2023
Sponsor
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05833984
Brief Title
Safety and Efficacy of IMM01 Plus Tislelizumab in Patients With Advanced Solid Tumors and Lymphomas
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2022 (Actual)
Primary Completion Date
February 7, 2024 (Anticipated)
Study Completion Date
November 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Classic Hodgkin Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
309 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation Part
Arm Type
Experimental
Arm Description
Mutiple dose level cohorts in the dose escalation part
Arm Title
Head and neck squamous cell carcinoma, nasopharyngeal carcinoma
Arm Type
Experimental
Arm Description
Dose expansion cohort with IMM01 plus Tislelizumab
Arm Title
Ovarian carcinoma
Arm Type
Experimental
Arm Description
Dose expansion cohort with IMM01 plus Tislelizumab
Arm Title
Non small cell lung carcinoma, small cell lung carcinoma
Arm Type
Experimental
Arm Description
Dose expansion cohort with IMM01 plus Tislelizumab
Arm Title
Hepatocellular carcinoma
Arm Type
Experimental
Arm Description
Dose expansion cohort with IMM01 plus Tislelizumab
Arm Title
Other solid tumors
Arm Type
Experimental
Arm Description
Dose expansion cohort with IMM01 plus Tislelizumab
Arm Title
Classic hodgkin lymphoma
Arm Type
Experimental
Arm Description
Dose expansion cohort with IMM01 plus Tislelizumab
Intervention Type
Drug
Intervention Name(s)
IMM01
Other Intervention Name(s)
SIRPα Fc
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Intervention Description
Tislelizumab 200mg Q3W IV
Primary Outcome Measure Information:
Title
Dose-limiting toxicity in dose escalation part
Time Frame
DLT observation 21 days
Title
MTD/RP2D in dose escalation part
Time Frame
DLT observation 21 days
Title
ORR in dose expansion part
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
TRAEs
Time Frame
up to 12 months
Title
PFS
Time Frame
up to 12 months
Title
DOR
Time Frame
up to 12 months
Title
DCR
Time Frame
up to 12 months
Title
Cmax
Time Frame
up to 12 months
Title
T1/2
Time Frame
up to 12 months
Title
AUC
Time Frame
up to 12 months
Title
ADA
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years old, male or female Life expectancy≥12 weeks; 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; ECOG PS of 0 or 1; Adequate organs function, including bone marrow, hepatic, renal, cardiac, coagulation. Adverse events associated with previous anti-tumor therapy have returned to≤ grade 1(NCI CTCAE V5.0); Exclusion Criteria: Previous treatment with CD47 inhibitor/SIRPαinhibitor or fusion protein; Patients with symptomatic or progressive central nervous system (CNS) metastasis; 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; A history of arterial thrombosis, deep venous thrombosis and pulmonary embolism within 3 months prior to administration; A history of moderate or severe dyspnea, interstitial lung disease (ILD) or servre pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency; With other malignant tumors; Diseases that may cause gastrointestinal bleeding or perforation; Uncontrollable pleural, peritoneal or pericardial effusions; A history of immunodeficiency; A history of autoimmune diseases; Uncontrolled severe active infections.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenzhen Zong
Phone
86-21-38016387
Email
zhenzhen.zong@immuneonco.com
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuan Zheng
Email
xuan.zheng@immuneonco.com
First Name & Middle Initial & Last Name & Degree
Zhengbo Song, M.D.
Facility Name
Shandong Provincial Institute of Cancer Prevention and Treatment
City
Jinan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuan Zheng
Email
xuan.zheng@immuneonco.com
First Name & Middle Initial & Last Name & Degree
Yan Zhang, M.D.
First Name & Middle Initial & Last Name & Degree
Hui Zhu, M.D.
Facility Name
The Third Affiliated Hospital of Qiqihar Medical University
City
Qiqihar
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiaqi Yang
Email
jiaqi.yang@immuneonco.com
First Name & Middle Initial & Last Name & Degree
Xu Tong, M.D.
Facility Name
Shanghai Chest Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuan Zheng
Email
xuan.zheng@immuneonco.com
First Name & Middle Initial & Last Name & Degree
Shun Lu, Ph.D.
Facility Name
Henan Cancer Hospital
City
Zhengzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rongqiang Sun
Email
rongqiang.sun@immuneonco.com
First Name & Middle Initial & Last Name & Degree
Yanqiu Zhao, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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