NCT05645315招募中1 期
A Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of TQB2618 Injection Combined With TQB2450 Injection in Patients With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 127
- 试验地点
- 5
- 主要终点
- Phase II recommended dose
研究概览
简要总结
This project is a phase Ib clinical trial study evaluating the efficacy and safety of TQB2618 injection combined with TQB2450 injection in patients with advanced solid tumors, the trial plan to enroll 127 subjects, the trial design is a phase I.b dose exploration and cohort expansion clinical study, aiming to evaluate the safety and efficacy of TQB2618 injection combined with TQB2450 injection in patients with advanced malignant solid tumors, and to evaluate TQB2618 injection, Pharmacokinetic characteristics, receptor occupancy and immunogenicity characteristics of TQB2450 injection; Biomarker studies related to the mechanism of action, safety and/or pathological mechanism of efficacy have dose-limiting toxicity (DLT) in Phase I, recommended dose in Phase II (RP2D), and objective response rate (ORR) in Phase II as the primary endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subjects voluntarily participated the study and signed the informed consent form;
- •Age: 18~75 years old (when signing the informed consent form); ECOG PS score: 0~1 points; Expected survival is more than 3 months;
- •The enrolled patients meet the following criteria:
- •Satge I (dose exploration): patients with advanced malignant solid tumors confirmed by tissue and/or cytology, where standard therapy has failed or there is a lack of effective treatment;
- •Stage 2 (cohort Expansion):
- •Cohort 1: PD-L1-positive patients with advanced first-line NSCLC;
- •Cohort 2: PD-L1 positive patients with advanced immunoresistant NSCLC;
- •Patients with locally advanced (stage III.B/III.C), recurrent or metastatic (stage IV) NSCLC who are not histologically or cytologically confirmed and are not suitable for radical concurrent chemoradiotherapy.
- •For non-squamous non-small cell lung cancer, the test proves the absence of EGFR mutation, ALK fusion, ROS1 mutation (for squamous non-small cell lung cancer, patients with known mutations in the above genes are excluded, and testing is not mandatory for those whose status is unknown);
- •Positive PD-L1 expression ratio≥1% [TC (tumor cells) or IC (immune cells) ≥1%];
- •Cohort 1 advanced first-line patients: no systemic antitumor therapy for advanced disease.
- •Patients with advanced immunoresistance in cohort 2: at least prior failure of platinum-containing chemotherapy and immune checkpoint inhibitor (PD-1 or PD-L1) therapy (combined or sequential therapy allowed)
- •at least one measurable lesion confirmed according to RECIST 1.1;
- •The main organs function normally
- •Female subjects of childbearing age should agree that contraception must be used during the study and for 6 months after the end of the study
排除标准
- •Comorbidities and medical history:
- •Have received chemotherapy within 3 weeks before the first dose, radiotherapy (except palliative radiotherapy for non-target lesions) or other antineoplastic drugs within 2 weeks before the first dose (the washout period is calculated from the end of the last treatment);
- •Have developed or are currently suffering from other malignant tumors within 3 years before the first dose. The following two conditions can be enrolled: other malignancies treated with a single surgery, achieving 5 consecutive years of disease-free survival (DFS); cured carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor-invasive basement membrane)];
- •unresolved toxicities above CTC AE grade 1 due to any prior treatment, excluding hair loss;
- •Major surgical treatment and obvious traumatic injury within 28 days before the first dose;
- •Wounds or fractures that have not healed for a long time;
- •Arterioven/venous thrombotic events within 6 months prior to the first dose;
- •Those with a history of psychotropic substance abuse and cannot quit or have mental disorders;
- •Subjects with any severe and/or uncontrolled disease.
- •Tumor-related symptoms and treatment:
- •Received proprietary Chinese medicine treatment with anti-tumor indications specified in the NMPA-approved drug instructions within 2 weeks before the first dose;
- •Have received previous anti-TIM-3 antibody treatment;
- •Have received previous immunotherapy drugs such as anti-PD-1/PD-L1 antibody and anti-CTLA-4 antibody (only applicable to cohort 1 of the Stage II cohort expansion study: advanced first-line NSCLC patients with positive PD-L1 expression);
- •uncontrolled pleural effusion, pericardial effusion, or ascites that still requires repeated drainage (judged by the investigator);
- •Known spinal cord compression, cancerous meningitis, with symptoms of brain metastases or symptom control for less than 2 weeks;
- •Study treatment-related:
- •History of live attenuated vaccination within 28 days before the first dose or planned live attenuated vaccination during the study period;
- •Those who have severe hypersensitivity reactions after using macromolecular drugs;
- •Active autoimmune disease requiring systemic therapy within 2 years before the first dose (e.g., use of disease-modifying drugs, corticosteroids, or immunosuppressants); asthma patients requiring bronchodilators for medical intervention.
- •Those who have participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first dose;
研究组 & 干预措施
TQB2618 injection+TQB2450 injection
Experimental
TQB2618 injection combined with TQB2450 injection, 21 days as a treatment cycle.
干预措施: TQB2618 injection and TQB2450 injection (Drug)
结局指标
主要结局
Phase II recommended dose
时间窗: Through phase 1 completion, an average of half a year
Dose selection in the expansion phase
Dose-limiting toxicity
时间窗: within the first treatment cycle for 21 days
The occurrence of severe toxicities during the first cycle of anti-cancer therapy
Objective response rate
时间窗: Up to 12 months
ORR is defined as the percentage of participants with progressive disease (PD) from first dose to first recorded or death from any cause of complete remission (CR) and partial remission (PR) based on investigator records
次要结局
- Disease control rate(Up to 12 months)
- Immunogenicity(Each cycle is 21 days. 1 hour before administration of cycles 1, 2, 4, and 8, 1 hour before administration at the start of every 6 cycles thereafter; 30 and 90 days after the last dose.)
- Free Tim3 receptors on the surface of CD3+ T cells(before and 30 minutes after the end of administration of per cycle during cycles 1-8; when patients withdrawn from the group due to Progression Disease)
- Adverse events (AEs)(Up to 28 days after last dose or the initiation of a new antineoplastic therapy, whichever comes first)
- Duration of remission(Up to 12 months)
- Maximum plasma drug concentration(1 hour before and 30 minutes after TQB2450 injection administration; 30 minutes, 4, 8, 24, 48, 144, 312 hours after TQB2618 injection administration of cycle 1; 30 minutes after TQB2618 injection administration of cycle 2-8. Each cycle is 21 days.)
- Progression-free survival(Up to 12 months)
- Overall survival(Up to 18 months)
研究者
研究点 (5)
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