Clinical Trial of TQB2618 Injection Combined With TQB2450 Injection in Patients With Advanced Solid Tumors

NCT ID: NCT05645315

Last Updated: 2022-12-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-28
• Study Completion Date: 2024-06-30

Brief Summary

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.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TQB2618 injection+TQB2450 injection

TQB2618 injection combined with TQB2450 injection, 21 days as a treatment cycle.

Group Type: EXPERIMENTAL

TQB2618 injection and TQB2450 injection

Intervention Type: DRUG

TQB2618 is a TIM-3 receptor monoclonal antibody; TQB2450 is a new sequence of innovative anti-PD-L1 fully humanized monoclonal antibody;

Interventions

TQB2618 injection and TQB2450 injection

TQB2618 is a TIM-3 receptor monoclonal antibody; TQB2450 is a new sequence of innovative anti-PD-L1 fully humanized monoclonal antibody;

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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:

1. 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;

2. Stage 2 (cohort Expansion):

1. Cohort 1: PD-L1-positive patients with advanced first-line NSCLC;

2. Cohort 2: PD-L1 positive patients with advanced immunoresistant NSCLC;

1. 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.

2. 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);

3. Positive PD-L1 expression ratio≥1% [TC (tumor cells) or IC (immune cells) ≥1%];

4. Cohort 1 advanced first-line patients: no systemic antitumor therapy for advanced disease.

5. 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

Exclusion Criteria

• Comorbidities and medical history:

1. 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);

2. 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)];

3. unresolved toxicities above CTC AE grade 1 due to any prior treatment, excluding hair loss;

4. Major surgical treatment and obvious traumatic injury within 28 days before the first dose;

5. Wounds or fractures that have not healed for a long time;

6. Arterioven/venous thrombotic events within 6 months prior to the first dose;

7. Those with a history of psychotropic substance abuse and cannot quit or have mental disorders;

8. Subjects with any severe and/or uncontrolled disease.

• Tumor-related symptoms and treatment:

1. Received proprietary Chinese medicine treatment with anti-tumor indications specified in the NMPA-approved drug instructions within 2 weeks before the first dose;

2. Have received previous anti-TIM-3 antibody treatment;

3. 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);

4. uncontrolled pleural effusion, pericardial effusion, or ascites that still requires repeated drainage (judged by the investigator);

5. Known spinal cord compression, cancerous meningitis, with symptoms of brain metastases or symptom control for less than 2 weeks;

• Study treatment-related:

1. History of live attenuated vaccination within 28 days before the first dose or planned live attenuated vaccination during the study period;

2. Those who have severe hypersensitivity reactions after using macromolecular drugs;

3. 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fujian Cancer Hospital

Fuzhou, Fujian, China

Site Status: NOT_YET_RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status: RECRUITING

Tongji Hospital,Tongji Medical College of HUST

Wuhan, Hubei, China

Site Status: NOT_YET_RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

Site Status: RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status: NOT_YET_RECRUITING

Countries

China

Central Contacts

Lin Wu, Doctor

Role: CONTACT

Phone: +86 13170419973

Email: wulin-calf@vip.163.com

Facility Contacts

Gen Lin, Doctor

Role: primary

Xing Ya Li, Doctor

Role: primary

Qian Chu, Doctor

Role: primary

Lin Wu, Doctor

Role: primary

Yong-sheng Wang, Doctor

Role: primary

Other Identifiers

TQB2618-TQB2450-Ib-01

Identifier Type: -

Identifier Source: org_study_id