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

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

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.

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