To Evaluate the Safety and Efficacy of TQB2858 Injection to the Subjects With Recurrent/Metastatic Nasopharyngeal Cancer

NCT05198531 | Unknown Phase 1

• 1 other identifier: TQB2858-Ib-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 7

Brief Summary

This study is a single-arm, randomized, open-label, multi-cohort Phase Ib clinical trial. The experimental drug is TQB2858 Injection. The trial was divided into 3 cohorts. Cohort 1 included patients with advanced nasopharyngeal carcinoma who had previously failed platinum-based chemotherapy and immune checkpoint inhibitors (programmed cell death protein 1 (PD-1)/ Programmed death-ligand 1 (PD-L1), etc.). Cohorts 2 and 3 were randomized into patients with advanced, untreated nasopharyngeal carcinoma who had not received prior systemic therapy. A total of 60-90 subjects are required.

Conditions

Recurrent / Metastatic Nasopharyngeal Cancer

Outcome Measures

Primary Outcomes (1)

• Adverse event rate

  The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).

  Baseline up to PD/die, about 20 months

Secondary Outcomes (5)

• Objective Response Rate(ORR)

  Baseline to CR/PR, about 16 months

• Progression-free survival (PFS)

  Baseline to PD/die, about 20 months

• Disease Control rate (DCR)

  Baseline to CR/PR/SD, about 16 months

• Duration of Overall Response (DOR)

  Baseline up to PD/die, about 20 months

• Overall survival (OS)

  Baseline up to die, about 46 months

Study Arms (1)

TQB2858 Injection combining with other drugs

EXPERIMENTAL

Combination 1 is TQB2858 Injection and Anlotinib Hydrochloride Capsules. Combination 2 is TQB2858 Injection, Gemcitabine Hydrochloride Injection and Cisplatin Injection for 4-6 cycles of induction chemotherapy, then using TQB2858 Injection and Anlotinib Hydrochloride Capsules for maintenance treatment. Combination 3 is TQB2858 Injection, Gemcitabine Hydrochloride Injection, Cisplatin Injection and Anlotinib Hydrochloride Capsules for 4-6 cycles of induction chemotherapy, then using TQB2858 Injection and Anlotinib Hydrochloride Capsules for maintenance treatment.

Drug: TQB2858 Injection; Drug: Anlotinib Hydrochloride Capsule; Drug: Gemcitabine hydrochloride injection; Drug: Cisplatin Injection

Interventions

TQB2858 Injection DRUG

TQB2858 Injection, a bifunctional fusion protein against Programmed death ligand 1 (PD-LI) and transforming growth factor-β (TGF-β). TQB2858 Injection blocks the PD-1/PD-L1 pathway and neutralizes TGF-β in the tumor microenvironment.

TQB2858 Injection combining with other drugs

Anlotinib Hydrochloride Capsule DRUG

Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.

TQB2858 Injection combining with other drugs

Gemcitabine hydrochloride injection DRUG

Gemcitabine hydrochloride, cell cycle-specific antimetabolites, mainly acting on tumor cells in the DNA synthesis phase (S phase cell). Under certain conditions, it can prevent the progression from G1 phase to S phase.

TQB2858 Injection combining with other drugs

Cisplatin Injection DRUG

After cisplatin enters cells, it reacts with DNA to form cross-links between two points or two strands in DNA, thereby inhibiting DNA replication and transcription, resulting in DNA breaks and miscoding.

TQB2858 Injection combining with other drugs

Eligibility Criteria

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

You may qualify if:

• Voluntarily joined the study and provide written informed consent and authorization permitting release of Protected Health Information.
• Male or female patient ≥18 and ≤75 years of age, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and life expectancy ≥12 weeks.
• Histologically or cytologically proven diagnosis of nasopharyngeal cancer (NPC), Stage IVb or not amenable for or local treatment (based on 2017, the 8th edition of the American Joint Committee on Cancer (AJCC) staging system of tumor-node-metastasis (TNM) of nasopharyngeal cancer).
• Subject meets one of the following criteria:
• Arm 1: Progression (Tumor-imaging proven) after platinum-based chemotherapy and Tumor Immunotherapy (PD-1/PD-L1 Checkpoint Inhibitors, etc.).
• Attention: Progression during therapy or after therapy within 6 months, neoadjuvant/ adjuvant therapy, radical chemoradiotherapy are considered as the first-line treatment.
• Arm 2 and 3: Not received systemic anti-tumor therapy for recurrent / metastatic nasopharyngeal cancer.
• Attention: Progression after therapy more than 6 months, neoadjuvant/ adjuvant therapy, radical chemoradiotherapy are not considered as the first-line treatment.
• Have at least 1 measurable disease defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
• Have adequate baseline function and performance status：
• a) Standard hematology test (no blood or product transfusions for a period of at least 7 days prior to enrollment).
• i. Hemoglobin (HGB) \>90 g/L; ii. Neutrophil count (NEUT) ≥1.5 × 109/L; iii. Platelets (PLT) ≥75 × 109/L;
• b) Serum chemistry i. Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 upper limit of normal (ULN) or ≤ 5 x ULN for subjects with hepatic metastatic tumor; ii. Bilirubin ≤ 1.5 x ULN or ≤ 3.0 x ULN for subjects with Gilbert Syndrome; iii. Creatinine ≤ 1.5 x ULN or Creatinine Clearance ≥ 60 mL/min;
• c) Blood Coagulation Test i. Activated Partial Thromboplastin Time (APTT), International Normalized Ratio (INR) and Prothrombin Time (PT) ≤ 1.5 (No anticoagulant therapy);
• d) left ventricular ejection fraction (LVEF) ≥ 50%;

You may not qualify if:

• Complicated disease and history:
• Has developed other malignant tumors within 3 years or is currently suffering from;
• With factors affecting take medicine orally (such as unable to swallow drugs or bowel obstruction, etc.)
• Unmitigated toxic reactions above Common Terminology Criteria for Adverse Events (CTCAE) grade 1 due to any prior treatment, excluding hair loss and peripheral sensory nerve disorders related to platinum-based chemotherapy;
• Received major surgical treatment, significant traumatic injury or long-term unhealed wounds or fractures (excluding needle biopsy for diagnosis, endoscope, etc.) within 28 days prior to the commencement of study treatment;
• With arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage), deep venous thrombosis and pulmonary embolism;
• With active pulmonary tuberculosis, idiopathic pulmonary fibrosis, organized pneumonia, drug-induced pneumonia, radiation pneumonia requiring treatment or active pneumonia with clinical symptoms;
• History of psychotropic substance abuse and inability to quit or with mental disorders;
• Received allogeneic bone marrow transplantation or solid organ transplantation;
• Subjects with any severe and/or uncontrolled disease:
• i. Uncontrolled hypertension (defined as systolic BP \>150 mm Hg or diastolic BP \> 100 mm Hg pressure)
• ii. Grade 2 or greater cardiac ischemia, myocardial infarction or cardiac arrhythmia (including QTc ≥ 480 ms) ;and New York Heart Association (NYHA) Grade II or greater congestive heart failure;
• iii. Active or uncontrolled infections;
• iv. Decompensated liver cirrhosis and active hepatitis (Hepatitis B reference: HBsAg positive, and HBV DNA\> 2500 copy/mL or \> 500 IU/mL; Hepatitis C reference: HCV antibody positive, and HCV RNA \> ULN);
• v. Renal failure requiring hemodialysis or peritoneal dialysis；

Sponsors & Collaborators

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

Study Sites (7)

Affiliated Cancer Hospital and Institute of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

Sun-Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518000, China

RECRUITING

The Fifth Affiliated Hospital Sun Yat-Sen University

Zhuhai, Guangdong, 519000, China

RECRUITING

Guangxi Tumor Hospital

Nanning, Guangxi, 530021, China

RECRUITING

Hainan General Hospital

Haikou, Hainan, 570100, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410006, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Interventions

Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Li Zhang, Master

CONTACT

13902282893; zhangli6@mail.sysu.edu.cn

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: January 19, 2022
• First Posted: January 20, 2022
• Study Start: January 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: August 1, 2023
• Last Updated: January 21, 2022

Record last verified: 2022-01

Locations

CN (7)