Study to Evaluate Safety and Efficacy of TJ107 Combine With PD-1 in Patients With Solid Tumors
NCT ID: NCT05145907
Last Updated: 2024-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
133 participants
INTERVENTIONAL
2021-12-22
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TJ107+Pembrolizumab
TJ107 1200ug/Kg,Q12W + Pembrolizumab 200mg Q3W
TJ107 +Pembrolizumab
TJ107 injection:1200ug/Kg, Q12W, IM; Pembrolizumab: 200mg, Q3W, IV
Interventions
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TJ107 +Pembrolizumab
TJ107 injection:1200ug/Kg, Q12W, IM; Pembrolizumab: 200mg, Q3W, IV
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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TJ Biopharma Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Liyang Song, Master
Role: STUDY_DIRECTOR
I-Mab Biopharma US Limited
Locations
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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, 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
Countries
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Other Identifiers
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TJ107001STM202
Identifier Type: -
Identifier Source: org_study_id
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