Back to resultsStudy to Evaluate Safety and Efficacy of TJ107 Combine With PD-1 in Patients With Solid Tumors
Primary Purpose
Triple-negative Breast Cancer, Head and Neck Squamous Cell Carcinoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TJ107 +Pembrolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Triple-negative Breast Cancer focused on measuring Triple-negative breast cancer, Head and neck squamous cell carcinoma, Solid Tumors
Eligibility Criteria
Inclusion Criteria:
- Male or female patients aged over 18 years (inclusive);
- ECOG score: 0 - 2 points
- Patients with histologically or cytologically confirmed locally advanced or metastatic solid tumors, including TNBC and HNSCC
- No previous treatment with CPI
- Agreement to provide a previously archived tumor tissue specimen or biopsy to collect tumor lesion tissue
- Subject has at least 1 measurable lesion as defined by RECIST V1.1
- Expected survival ≥ 6 months
- Adequate organ function
- Males of childbearing potential or females of childbearing potential must use highly effective contraceptive methods during the trial and continuing for 6 months after the last dose
- The subject voluntarily joined the study and signed an informed consent form
Exclusion Criteria:
- Pregnant or lactating women;
- Prior cell therapy;
- Received systemic anti-tumor therapy within 2 weeks or 5 half-lives of the treatment agent (whichever is shorter) before the start of treatment;
- Previous or current presence of two or more primary tumors
- Patients with active autoimmune diseases
- Have received systemic treatment with corticosteroids (10 mg prednisone equivalent daily) or other immunosuppressive agents for more than 7 days within 2 weeks before the start of treatment
- Received investigational drugs within 2 weeks before the start of treatment;
- Major surgery or serious trauma within 4 weeks before the start of treatment;
- Patients with symptomatic central nervous system (CNS) metastasis
- Active viral infectious disease requiring systemic treatment at screening:
- Known serious hypersensitivity history
- Uncontrolled pleural effusion, ascites, or pericardial effusion at screening;
- Presence or history of active interstitial lung disease;
- Patients with hypertension that cannot be well controlled with medical therapy.
- Presence of clinically significant cardiovascular disease
- Deep venous thrombosis within 6 months before the start of treatment
- Thrombolytic therapy within 10 days prior to the start of treatment
- Any active infection requiring intravenous anti-infective therapy before the start of treatment
- Had toxicity not resolved to ≤ Grade 1 (CTCAE 5.0) from previous anticancer therapy
- Known or suspected inability to comply with the study protocol
Sites / Locations
- The First Affiliated Hospital of Anhui Medical University
- The Second Hospital of Anhui Medical University
- Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeRecruiting
- Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen CenterRecruiting
- Hainan General Hospital
- Harbin Medical University Cancer Hospital
- Hubei Cancer Hospital
- Tongji Hospital, Tongji Medical College of Huzhong University of Science and Technology
- The Second Xiangya Hospital of Central South University
- Jilin Guowen Hospital
- Jilin Cancer Hospital
- The First Hospital of Jilin University
- Yanbian University HospitalRecruiting
- The First Hospital of China Medical University
- Fudan University Shanghai Cancer Center
- Shanghai East Hospital
- Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine
- Tianjin Medical University Cancer Institute & Hospital
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
- Zhejiang Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TJ107+Pembrolizumab
Arm Description
TJ107 1200ug/Kg,Q12W + Pembrolizumab 200mg Q3W
Outcomes
Primary Outcome Measures
The rate of Adverse events
The rate of Adverse events
The rate of Senior Adverse Events
The rate of Senior Adverse Events
Secondary Outcome Measures
Full Information
NCT ID
NCT05145907
First Posted
November 1, 2021
Last Updated
July 8, 2022
Sponsor
I-Mab Biopharma Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05145907
Brief Title
Study to Evaluate Safety and Efficacy of TJ107 Combine With PD-1 in Patients With Solid Tumors
Official Title
A Multicenter, Open-label, Exploratory Phase II Clinical Study to Evaluate the Safety and Tolerability and Preliminary Efficacy of TJ107 Combine With Pembrolizumab Injection in Patients With Locally Advanced or Metastatic Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
I-Mab Biopharma Co. Ltd.
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
Study Purpose and Design:A Multicenter, Open-label, Exploratory Phase II Clinical Study to Evaluate the Safety and Tolerability and Preliminary Efficacy of TJ107 in Combination with Pembrolizumab Injection in Patients with Locally Advanced or Metastatic Solid Tumors
Detailed Description
This open-label, multicenter phase 2 study will enroll 28 to 39 subjects in each of the following 4 cohorts Cohort 1 Triple-negative breast cancer Cohort 2 Head and neck squamous cell carcinoma Cohort 3 Other tumor species (to be determined) Cohort 4 Other tumor species (to be determined) The trial consists of two phases, the first is a safety run-in phase and the second is a case extension phase.
In the safety run-in phase, 3 subjects will be treated with TJ107 (1200 µg/kg q12w) combined with Pembrolizumab Injection (200 mg q3w) first. A safety assessment was conducted by a safety assessment committee composed of the sponsor and the investigator on the first dose in these 3 subjects to determine that the dose of TJ107 1200 µg/kg was safe and to determine whether to continue the safety assessment in these 3 patients, either at this dose level, or at a dose or dosing interval adjustment (e.g., the dose of TJ107 was adjusted to 960 ug/kg or the dosing interval was adjusted).
In the case expansion phase, 28-39 subjects will be enrolled in each cohort, and TJ107 (1200 µg/kg q12w) combined with Pembrolizumab Injection (200 mg q3w) or TJ107 adjusted dose combined with Pembrolizumab Injection (200 mg q3w) will be administered until intolerance or disease progression and other endpoint events occur.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple-negative Breast Cancer, Head and Neck Squamous Cell Carcinoma
Keywords
Triple-negative breast cancer, Head and neck squamous cell carcinoma, Solid Tumors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Open-label, single arm
Masking
None (Open Label)
Allocation
N/A
Enrollment
133 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TJ107+Pembrolizumab
Arm Type
Experimental
Arm Description
TJ107 1200ug/Kg,Q12W + Pembrolizumab 200mg Q3W
Intervention Type
Biological
Intervention Name(s)
TJ107 +Pembrolizumab
Intervention Description
TJ107 injection:1200ug/Kg, Q12W, IM; Pembrolizumab: 200mg, Q3W, IV
Primary Outcome Measure Information:
Title
The rate of Adverse events
Description
The rate of Adverse events
Time Frame
Through the study assessed up to 2 years
Title
The rate of Senior Adverse Events
Description
The rate of Senior Adverse Events
Time Frame
Through the study assessed up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients aged over 18 years (inclusive);
ECOG score: 0 - 2 points
Patients with histologically or cytologically confirmed locally advanced or metastatic solid tumors, including TNBC and HNSCC
No previous treatment with CPI
Agreement to provide a previously archived tumor tissue specimen or biopsy to collect tumor lesion tissue
Subject has at least 1 measurable lesion as defined by RECIST V1.1
Expected survival ≥ 6 months
Adequate organ function
Males of childbearing potential or females of childbearing potential must use highly effective contraceptive methods during the trial and continuing for 6 months after the last dose
The subject voluntarily joined the study and signed an informed consent form
Exclusion Criteria:
Pregnant or lactating women;
Prior cell therapy;
Received systemic anti-tumor therapy within 2 weeks or 5 half-lives of the treatment agent (whichever is shorter) before the start of treatment;
Previous or current presence of two or more primary tumors
Patients with active autoimmune diseases
Have received systemic treatment with corticosteroids (10 mg prednisone equivalent daily) or other immunosuppressive agents for more than 7 days within 2 weeks before the start of treatment
Received investigational drugs within 2 weeks before the start of treatment;
Major surgery or serious trauma within 4 weeks before the start of treatment;
Patients with symptomatic central nervous system (CNS) metastasis
Active viral infectious disease requiring systemic treatment at screening:
Known serious hypersensitivity history
Uncontrolled pleural effusion, ascites, or pericardial effusion at screening;
Presence or history of active interstitial lung disease;
Patients with hypertension that cannot be well controlled with medical therapy.
Presence of clinically significant cardiovascular disease
Deep venous thrombosis within 6 months before the start of treatment
Thrombolytic therapy within 10 days prior to the start of treatment
Any active infection requiring intravenous anti-infective therapy before the start of treatment
Had toxicity not resolved to ≤ Grade 1 (CTCAE 5.0) from previous anticancer therapy
Known or suspected inability to comply with the study protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaolin Wang, Bachelor
Phone
+86 13825619560
Email
xiaolin.wang@i-mabbiopharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wang
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liyang Song, Master
Organizational Affiliation
I-Mab Biopharma Co. Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingying Du
Facility Name
The Second Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhendong Chen
Facility Name
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Binghe Xu, Doctor
Phone
+86 13501028690
Email
bhxu@hotmail.com
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
City
Shenzhen
State/Province
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Huang, Doctor
Facility Name
Hainan General Hospital
City
Haikou
State/Province
Hainan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Wang
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingyuan Zhang
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youhua Zhu
First Name & Middle Initial & Last Name & Degree
Youhua Zhu
First Name & Middle Initial & Last Name & Degree
Xinhong Wu
Facility Name
Tongji Hospital, Tongji Medical College of Huzhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huihua Xiong
First Name & Middle Initial & Last Name & Degree
Huihua Xiong
First Name & Middle Initial & Last Name & Degree
Guangyuan Hu
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianling Liu
First Name & Middle Initial & Last Name & Degree
Xianling Liu
First Name & Middle Initial & Last Name & Degree
Enxiang Zhou
Facility Name
Jilin Guowen Hospital
City
Chang chun
State/Province
Jilin
Country
China
Individual Site Status
Enrolling by invitation
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Cheng
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Li
Facility Name
Yanbian University Hospital
City
Yanji
State/Province
Jilin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Songnan Zhang
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Funan Liu
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Zhang
Facility Name
Shanghai East Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Enrolling by invitation
Facility Name
Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laiping Zhong, Doctor
First Name & Middle Initial & Last Name & Degree
Bin Jiang, Doctor
First Name & Middle Initial & Last Name & Degree
Laiping Zhong, Doctor
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongsheng Tong
First Name & Middle Initial & Last Name & Degree
Zhongsheng Tong
First Name & Middle Initial & Last Name & Degree
Xudong Wang
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xian Wang
First Name & Middle Initial & Last Name & Degree
Xian Wang
First Name & Middle Initial & Last Name & Degree
Xiaonan Sun
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Enrolling by invitation
12. IPD Sharing Statement
Plan to Share IPD
No
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Study to Evaluate Safety and Efficacy of TJ107 Combine With PD-1 in Patients With Solid Tumors
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