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

NCT05645315 | Unknown Phase 1

• 1 other identifier: TQB2618-TQB2450-Ib-01
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (3)

• Dose-limiting toxicity

  The occurrence of severe toxicities during the first cycle of anti-cancer therapy

  within the first treatment cycle for 21 days

• Phase II recommended dose

  Dose selection in the expansion phase

  Through phase 1 completion, an average of half a year

• Objective response rate

  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

  Up to 12 months

Secondary Outcomes (8)

• Progression-free survival

  Up to 12 months

• Disease control rate

  Up to 12 months

• Duration of remission

  Up to 12 months

• Overall survival

  Up to 18 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.

Study Arms (1)

TQB2618 injection+TQB2450 injection

EXPERIMENTAL

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

Drug: TQB2618 injection and TQB2450 injection

Interventions

TQB2618 injection and TQB2450 injection DRUG

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

TQB2618 injection+TQB2450 injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (5)

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

RECRUITING

Tongji Hospital,Tongji Medical College of HUST

Wuhan, Hubei, 430030, China

NOT YET RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410005, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

NOT YET RECRUITING

Central Study Contacts

Lin Wu, Doctor

CONTACT

+86 13170419973; wulin-calf@vip.163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 9, 2022
• Study Start: April 28, 2022
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: December 9, 2022

Record last verified: 2022-11

Locations

CN (5)