A Clinical Trial of TQB2618 Injection Combined With Penpulimab Injection and Chemotherapy Versus Penpulimab Injection Combined With Chemotherapy in First-line Treatment of Relapsed/Metastatic Head and Neck Squamous Cell Carcinoma

NCT05783921 | Unknown Phase 1

• 1 other identifier: TQB2618-AK105-Ib-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 12

Brief Summary

To evaluate the efficacy and safety of TQB2618 injection combined with Penpulimab and chemotherapy in the first-line treatment of relapsed/metastatic head and neck squamous cell carcinoma compared to Penpulimab combined chemotherapy. Progression-free survival (PFS) and objective response rate (ORR) were the primary efficacy endpoints.

Conditions

Recurrent Squamous Cell Carcinoma of the Head and Neck; Metastatic Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• Progression free survival (PFS)

  The time period from the first administration of the drug to disease progression or death event (whichever occurs first).

  Baseline to up to two years.

• Objective response rate (ORR)

  According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and iRECIST, the proportion of subjects whose tumors are evaluated as complete response(CR) and partial response(PR) by subcenter imaging evaluation. It is recorded from the first administration of the drug to disease progression or initiation of a new anticancer treatment.

  Baseline to up to two years.

Secondary Outcomes (8)

• PFS rate at 9 months

  Baseline to 9 months

• Overall survival (OS)

  Baseline to up to two years.

• Disease Control Rate (DCR)

  Baseline to up to two years.

• Clinical benefit rate (CBR)

  Baseline to up to two years.

• Duration of Remission (DOR)

  Baseline to up to two years.

Study Arms (2)

TQB2618 injection +Penpulimab injection+Chemotherapy (Paclitaxel+Cisplatin or Carboplatin)

EXPERIMENTAL

TQB2618 injection combined with Penpulimab injection, Paclitaxel, Cisplatin or Carboplatin, 21 days as a treatment cycle. After 4\~6 cycles, TQB2618 injection combined with Penpulimab injection, 21 days as a treatment cycle.

Drug: TQB2618 injection, Penpulimab injection, Paclitaxel, Cisplatin or Carboplatin

Penpulimab injection + Chemotherapy (Paclitaxel+Cisplatin or Carboplatin)

ACTIVE COMPARATOR

Penpulimab injection combined with Paclitaxel, Cisplatin or Carboplatin, 21 days as a treatment cycle. After 4\~6 cycles, Penpulimab injection, 21 days as a treatment cycle.

Drug: Penpulimab injection, Paclitaxel, Cisplatin or Carboplatin

Interventions

TQB2618 injection, Penpulimab injection, Paclitaxel, Cisplatin or Carboplatin DRUG

TQB2618 injection is an Anti TIM-3 (T-cell immunoglobulin and mucin domain-3) monoclonal antibody. Penpulimab injection is a humanized Monoclonal Antibody target Programmed Cell Death Protein 1 (PD-1). Paclitaxel is a anti-microtubule drug, which promotes tubulin polymerization, inhibits depolymerization, maintains tubulin stability and inhibits cell mitosis. Cisplatin inhibits DNA synthesis by generating in-strand interstrand crosslinking with DNA. Protein and RNA synthesis can also be inhibited. Carboplatin is a cyclic nonspecific antitumor agents that cause cross-linking between DNA strands and affect their synthesis to inhibit cancer cells.

TQB2618 injection +Penpulimab injection+Chemotherapy (Paclitaxel+Cisplatin or Carboplatin)

Penpulimab injection, Paclitaxel, Cisplatin or Carboplatin DRUG

Penpulimab injection is a humanized Monoclonal Antibody target Programmed Cell Death Protein 1 (PD-1). Paclitaxel is a anti-microtubule drug, which promotes tubulin polymerization, inhibits depolymerization, maintains tubulin stability and inhibits cell mitosis. Cisplatin inhibits DNA synthesis by generating in-strand interstrand crosslinking with DNA. Protein and RNA synthesis can also be inhibited. Carboplatin is a cyclic nonspecific antitumor agents that cause cross-linking between DNA strands and affect their synthesis to inhibit cancer cells.

Penpulimab injection + Chemotherapy (Paclitaxel+Cisplatin or Carboplatin)

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 joined the study, signed the informed consent form, and had good compliance.
• Between the ages of 18-75 years (calculated based on the date of signing ICF); male or female; Eastern cooperative oncology group (ECOG) score 0-1; estimated survival time ≥ 3 months.
• No indications of local radical therapy for recurrence/metastasis head and neck squamous cell carcinoma.And histologically- or cytologically-confirmed head and neck squamous cell carcinoma ，Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx.
• No systemic therapy for recurrent/metastatic lesions, but excluding systemic therapy for locally advanced disease as a part of multimodal therapy (including induction therapy, systemic therapy in the same period of radiotherapy, and adjuvant therapy), and the completion time of treatment was more than 6 months from enrollment (according to the date of informed consent);
• At least one measurable lesion (based on RECIST1.1).
• The main organs function are normally, the following criteria are met:
• hemoglobin (Hb) ≥90g/L (no blood transfusion and blood products within 14 days) ；absolute neutrophil count (ANC) ≥1.5×109/L； platelets (PLT) ≥90×109/L.
• Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN. If accompanied by liver metastases, ALT and AST ≤ 5×ULN; Serum creatinine (CR) ≤ 1.5×ULN or creatinine clearance (CCR) ≥ 60 ml/min.
• Prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR) ≤ 1.5×ULN (no anticoagulant therapy); Thyroid-stimulating hormone (TSH) ≤ ULN; If abnormalities should be examined, T3 and T4 levels should be examined, and T3 and T4 levels are normal.
• Cardiac ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ 50%.
• Female participants of childbearing age should agree to use contraception (e.g., IUDs, pills, or condoms) during the study period and for 6 months after the end of the study; Have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Male participants should agree that contraception must be used during the study period and for 6 months after the end of the study period.

You may not qualify if:

• Comorbidity and medical history:
• Have had or currently have other malignant tumors within 3 years. The following two conditions can be enrolled: other malignancies treated with a single surgery to achieve 5-year disease-free survival (DFS); cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors \[Ta (non-invasive tumors), Tis (carcinoma in situ) and T1 (tumor-invasive basement membrane)\];
• adverse effects due to any prior treatment have not been restored to CTCAE 5.0 ≤ level 1 (except for toxicity where the investigator determines that there is no safety risk);
• Major surgical treatment, incision biopsy, or significant traumatic injury were received within 28 days prior to study treatment
• Long-term unhealed wounds or fractures
• Arteriovenous thrombotic events within 6 months, such as cerebrovascular accidents;
• Those who have a history of psychotropic substance abuse and cannot quit or have a mental disorder;
• Subjects with any severe and/or uncontrolled medical conditions, including:
• Unsatisfactory blood pressure control (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥100 mmHg);
• Have grade ≥2 myocardial ischemia or myocardial infarction, arrhythmias (including QTc ≥ 450 ms (male) in men and QTc ≥ 470 ms (female)) and grade ≥ congestive heart failure grade 2 (New York Heart Association (NYHA) grade);
• Active or uncontrolled severe infection (≥ CTC AE grade 2 infection) or unexplained fever \> 38.5°C;
• Liver cirrhosis, active hepatitis Note: Active hepatitis (hepatitis B reference: HBsAg positive and HBV (hepatitis B virus) DNA detection value of more than 1000 copies /mL; Hepatitis C reference: HCV (hepatitis C virus) antibody positive, and HCV virus titer test value above the upper limit of normal);
• Known to have syphilis;
• Renal failure requires hemodialysis or peritoneal dialysis
• A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;

Sponsors & Collaborators

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

Study Sites (12)

Gansu Prouincial Cancer Hospital

Lanzhou, Gansu, 730000, China

RECRUITING

Jiangmen Central Hospital

Jiangmen, Guangdong, 529030, China

RECRUITING

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, 530000, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

RECRUITING

AnYang Tumor Hospital

Anyang, Henan, 455000, China

RECRUITING

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471003, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

RECRUITING

Zhumadian Centre Hospital

Zhumadian, Henan, 463003, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410000, China

RECRUITING

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330006, China

RECRUITING

Liaoning Cancer hospital

Shenyang, Liaoning, 110000, China

RECRUITING

The Second Hospital Of Dalian Medical University

Shenyang, Liaoning, 116027, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma, Squamous Cell

Interventions

penpulimab; Paclitaxel; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes

Study Design

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

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 24, 2023
• Study Start: May 23, 2023
• Primary Completion: August 1, 2024
• Study Completion: January 1, 2025
• Last Updated: July 28, 2023

Record last verified: 2023-07

Locations

CN (12)