Overview

TQB2618 Injection Combined With Penpulimab Injection in the Treatment of Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

Status:
Not yet recruiting
Trial end date:
2024-05-01
Target enrollment:
0
Participant gender:
All
Summary
Cohort 1 was a two-phase study design: a phase I dose-exploration study to determine the dose of TQB2618 combined with Penpulimab Injection; Phase II extension study, case expansion based on the dose administered as determined in phase I. The two-phase cohort 1 study enrolled subjects with advanced nasopharyngeal carcinoma who had failed previous platinum-based chemotherapy and immune checkpoint inhibitors (PD-1/PD-L1, etc.).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Treatments:
Cisplatin
Gemcitabine
Criteria
Inclusion Criteria:

- Histologically or cytologically confirmed nasopharyngeal carcinoma, stage IVb as
defined by the AJCC TNM staging system for nasopharyngeal carcinoma, 8th edition in
2017 or subjects with recurrent nasopharyngeal carcinoma who were not suitable for
local therapy (For neoadjuvant/adjuvant therapy and radical concurrent
chemoradiotherapy, if the disease progresses during treatment or within 6 months after
the treatment completion, it should be counted as a failure of first-line treatment of
the original plan, and if it exceeds 6 months, it cannot be counted as first-line
treatment failure. Alterations of treatment regimen due to drug intolerance are not
defined as treatment failure):

1. cohort 1: Patients who have received at least platinum-containing chemotherapy
and immune checkpoint inhibitors (PD-1/PD-L1, etc.) in the past have failed, and
there is evidence of imaging progression;

2. cohort 2:

1. Have not received systemic antitumor therapy for recurrent/metastatic
nasopharyngeal carcinoma before;

2. No previous treatment with immune checkpoint inhibitors (PD-1/PD-L1, etc.).

- At least one measurable lesion confirmed according to RECIST 1.1 criteria;

- The function of main organs are well and meet the following standards:

1. Routine Blood routine examination standards (without blood transfusion or
correction with hematopoietic stimulating factor drugs within 14 days before the
examination):

1. Hemoglobin (HGB) ≥90 g/L;

2. Absolute value of neutrophil (NEUT) ≥1.5×109/L;

3. Platelets count (PLT) ≥ 100×109/L.

2. The biochemical examination shall meet the following standards:

1. Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN) (Patients
with Gilbert syndrome ≤ 3 × ULN);

2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 ×
ULN. If it is accompanied by liver metastasis, ALT and AST ≤ 5 × ULN;

3. Serum creatinine (CR) ≤ 1.5 × ULN or Creatinine clearance (CCR) ≥ 60 ml/min;

3. Blood coagulation function or thyroid function test should meet the following
standards: Prothrombin time (PT), activated partial thromboplastin time (APTT),
international normalized ratio (INR)≤1.5×ULN (no anticoagulant therapy);

4. Thyroid Stimulating Hormone (TSH) ≤ ULN; if abnormal, T3 and T4 levels should be
examined. If T3 and T4 levels are normal, it can be selected.

5. Heart color Doppler ultrasound assessment: Left ventricular ejection fraction
(LVEF) ≥50%.

- Female subjects of reproductive age should agree that they must conduct contraceptive
measures (such as intrauterine devices, contraceptives, or condoms) during and for 6
months after the study; Female subjects should have a negative serum/urine pregnancy
test within 7 days prior to study enrollment and must be non-lactating; Male subjects
should agree that they must conduct contraception during the study period and for 6
months after the study.

Exclusion Criteria:

- Combined diseases and medical history:

1. Other malignant tumors have occurred or are currently suffering from other
malignant tumors within 5 years before the first medication, except for fully
treated non-melanoma skin cancer, cervical carcinoma in situ and papillary
thyroid carcinoma;

2. Unresolved toxicities greater than CTC AE grade 1 due to any prior therapy,
excluding alopecia, neurotoxic sequelae associated with prior platinum therapy;

3. Received major surgical treatment, obvious traumatic injury (excluding needle
biopsy, endoscopic biopsy, etc.) within 28 days before the first drug;

4. Arterial/venous thrombotic events, such as cerebrovascular accident (including
transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein
thrombosis and pulmonary embolism, occurred within 6 months before the first
drug;

5. Active pulmonary tuberculosis, history of idiopathic pulmonary fibrosis,
organizing pneumonia, drug-induced pneumonia, radiation pneumonitis requiring
treatment, or active pneumonia with clinical symptoms;

- Cancer-related symptoms and treatment:

1. Received NMPA-approved Chinese patent medicines with anti-tumor indications in
the drug insert within 2 weeks prior to the first administration;

2. Received surgery, chemotherapy, radiotherapy or other anti-cancer therapy within
3 weeks before the start of study treatment (the washout period is calculated
from the end of the last treatment); those who have received local radiotherapy
in the past can be enrolled if they meet the following conditions: radiotherapy
The end of the study treatment is more than 3 weeks (more than 2 weeks for brain
radiotherapy); and the target lesions selected in this study are not in the
radiotherapy area;

3. Previous treatment with anti-TIM-3 antibodies;

4. The nasopharyngeal lesions recurred after radiotherapy and received
Re-radiotherapy;

5. maging (CT or MRI) shows that the tumor has invaded around important blood
vessels, and it is judged by the investigator that the tumor is very likely to
invade important blood vessels and cause fatal hemorrhage during the follow-up
study;

6. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated
drainage;

7. Known uncontrolled or symptomatic active central nervous system (CNS) metastases
presenting with clinical symptoms, cerebral edema, spinal cord compression,
cancerous meningitis, leptomeningeal disease, and/or progressive growth. Patients
with a history of CNS metastases or spinal cord compression were eligible if they
were clearly treated and clinically stable after 4 weeks of discontinuation of
anticonvulsants, steroids, or dehydrating agents prior to the first dose of the
study.