Study to Evaluate Safety and Efficacy of TJ107 Combine With PD-1 in Patients With Solid Tumors
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
1 other identifier
interventional
133
1 country
20
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2021
Typical duration for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2021
CompletedFirst Posted
Study publicly available on registry
December 6, 2021
CompletedStudy Start
First participant enrolled
December 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedApril 15, 2024
April 1, 2024
2.5 years
November 1, 2021
April 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The rate of Adverse events
The rate of Adverse events
Through the study assessed up to 2 years
The rate of Senior Adverse Events
The rate of Senior Adverse Events
Through the study assessed up to 2 years
Study Arms (1)
TJ107+Pembrolizumab
EXPERIMENTALTJ107 1200ug/Kg,Q12W + Pembrolizumab 200mg Q3W
Interventions
TJ107 injection:1200ug/Kg, Q12W, IM; Pembrolizumab: 200mg, Q3W, IV
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021, China
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen, Guangzhou, China
Hainan General Hospital
Haikou, Hainan, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Tongji Hospital, Tongji Medical College of Huzhong University of Science and Technology
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Jilin Cancer Hospital
Changchun, Jilin, China
Jilin Guowen Hospital
Changchun, Jilin, China
The First Hospital of Jilin University
Changchun, Jilin, China
Yanbian University Hospital
Yanji, Jilin, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Liyang Song, Master
I-Mab Biopharma US Limited
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2021
First Posted
December 6, 2021
Study Start
December 22, 2021
Primary Completion
June 30, 2024
Study Completion
December 31, 2024
Last Updated
April 15, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share