Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Triple-negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TJ107 +Pembrolizumab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TJ107+Pembrolizumab
- description
- TJ107 1200ug/Kg,Q12W + Pembrolizumab 200mg Q3W
- interventionNames
- Biological: TJ107 +Pembrolizumab
Primary outcomes (2)
- measure
- The rate of Adverse events
- timeFrame
- Through the study assessed up to 2 years
- description
- The rate of Adverse events
- measure
- The rate of Senior Adverse Events
- timeFrame
- Through the study assessed up to 2 years
- description
- The rate of Senior Adverse Events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available