Study to Evaluate Safety and Efficacy of TJ107 Combine With PD-1 in Patients With Solid Tumors

TJ Biopharma Co., Ltd.

Status and phase

Active, not recruiting

Phase 2

Conditions

Triple-negative Breast Cancer

Head and Neck Squamous Cell Carcinoma

Treatments

Biological: TJ107 +Pembrolizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05145907

TJ107001STM202

Details and patient eligibility

About

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

Full 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.

Enrollment

133 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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