A Clinical Trial to Evaluate Tolerability and Pharmacokinetics of TQB2858 Injection in Subjects With Advanced Malignancy

NCT05068921 | Unknown Phase 1

• 1 other identifier: TQB2858-Ⅰ-06
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 17

Brief Summary

A phase I clinical trial of tolerability and pharmacokinetics of TQB2858 injection in subjects with advanced malignancy.

Conditions

Advanced Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rates (ORR)

  Proportion of patients whose tumors shrank by a certain amount and remained for a certain period of time, including complete response (CR) and partial response (PR) .

  Baseline to up to two years

Secondary Outcomes (5)

• Progress Free Survival(PFS)

  Baseline to up to two years

• Disease Control Rate(DCR)

  Baseline to up to two years

• Duration of Response(DOR)

  Baseline to up to two years

• Overall Survival(OS)

  Baseline to up to two years

• Occurrence of all adverse events (AE), serious adverse events (SAE), and treatment-related adverse events (TEAEs)

  Baseline to up to two years

Study Arms (1)

TQB2858

EXPERIMENTAL

TQB2858 injection: once every 3 weeks, 1800mg each time, intravenous infusion. Until the disease progression or unbearable adverse events occur.

Drug: TQB2858 injection

Interventions

TQB2858 injection DRUG

TQB2858 is an anti-programmed death ligand 1（PD-L1）/transforming growth factor-β （TGF-β） bi-functional fusion protein.

TQB2858

Eligibility Criteria

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

You may qualify if:

• \) All the following conditions were met for the corresponding study stage:
• a) Cervical cancer confirmed by histopathology, including squamous carcinoma, adenocarcinoma and adenosquamous carcinoma; b) Have received ≥1 line of platinum-containing chemotherapy (at least ≥3 cycles of platinum-containing chemotherapy) in the past, and have disease progression or recurrence during or after treatment; c) Confirmed presence of at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors(RECIST) 1.1 standard;
• \) Aged: 18 \~ 75 years old
• )Physical condition score( Eastern Cooperative Oncology Group(ECOG) score): 0\~1
• \) estimated survival time ≥ 3 months
• )The main organs function well and meet the following standards:
• a) Routine blood examination standards (without blood transfusion or correction with hematopoietic stimulating factor drugs within 14 days before screening):Hemoglobin (HGB) ≥80 g/L; Neutrophil count (NEUT) ≥ 1.5×109/L; Platelets (PLT)≥90×109 /L; b) Biochemical examination: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN (Primary hepatobiliary tumor or liver metastasis: ALT, AST≤ 5×ULN ); Total bilirubin (TBIL) ≤1.5×ULN (Gilbert syndrome patients: TBIL≤ 3×ULN); Creatinine (CRE) ≤ 1.5×ULN or creatinine clearance ≥ 60 mL /min; c) Blood coagulation function: activated partial thrombin time (APTT), international standardized ratio (INR), prothrombin time (PT) ≤ 1.5×ULN (without anticoagulant therapy); d) Left ventricular ejection fraction (LVEF) ≥ 50%;
• \) Female subjects of childbearing age should agree to use effective contraceptive measures (such as intrauterine device , birth control pills or condoms) during the study period and within 6 months after the end of the study, and have a negative serum pregnancy test within 7 days before the study enrollment and must be non-lactating subjects;
• ）The subjects voluntarily joined the study, signed the informed consent form, and had good compliance.

You may not qualify if:

• \) Combined following diseases or medical history:
• the presence of other malignant tumors within 2 years or current co-occurrence . The following two conditions can be included: other malignant tumors treated by single surgery, achieved R0 resection and no recurrence and metastasis; Cured cervical carcinoma in situ (only applicable to the first stage), non-melanoma skin cancer, nasopharyngeal carcinoma, and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basal membrane)\];
• Pathological findings of mucinous adenocarcinoma, clear cell adenocarcinoma, neuroendocrine tumor and other special pathological types (only applicable to the second stage);
• Evaluation criteria for common adverse events(CTCAE) grade\> 1 unrelieved toxicity of due to any prior treatment, excluding hair loss and peripheral sensory nerve disorders;
• major surgical treatment or significant traumatic injury within 28 days prior to the start of study treatment (excluding needle aspiration, endoscopic biopsy for diagnostic purposes, etc.);
• wounds or fractures that have not been cured for a long time;
• Occurrence of arteriovenous/venous thrombosis events within 6 months, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.;
• those who have a history of psychotropic drug abuse and cannot quit or have mental disorders;
• Subject with any severe and/or uncontrolled disease, including:
• Patients with poor blood pressure control after standard treatment (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥ 100mmHg);
• Patients who have experienced myocardial ischemia or myocardial infarction within six months; New York Heart Association(NYHA )grade ≥2 congestive heart failure; Grade ≥2 atrioventricular block; Arrhythmias that cannot be stably controlled with drugs (including QTc ≥470ms) and arrhythmias that may have a potential impact on trial treatment;
• Active infection ( CTCAE grade ≥ 2 infection);
• Decompensated liver cirrhosis, active hepatitis \*;
• Active syphilis and active tuberculosis;
• Renal failure requiring hemodialysis or peritoneal dialysis: glomerular filtration rate(eGFR) \< 15ml/ (min•1.73㎡);

Sponsors & Collaborators

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

Study Sites (17)

Affiliated Tumor Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

RECRUITING

The Third Affiliated Hospital of Qiqihar Medical College

Qiqihar, Heilongjiang, 161099, China

RECRUITING

Hunan Cancer Hospita

Changsha, Hunan, 410013, China

RECRUITING

Affiliated Hospital of Changchun University of Chinese Medicine

Changchun, Jilin, 130000, China

RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Linyi Tumor Hospital

Linyi, Shandong, 276000, China

RECRUITING

Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266001, China

RECRUITING

Qingdao Central Hospital

Qingdao, Shandong, 266042, China

RECRUITING

The Second Affiliated Hospital of Shandong First Medical University

Taian, Shandong, 271099, China

RECRUITING

Yantai Yuhuangding Hospital

Yantai, Shandong, 264099, China

RECRUITING

Affiliated Peace Hospital of Changzhi Medical College

Changzhi, Shanxi, 046000, China

RECRUITING

The First Affiliated Hospital of Xi 'an Jiaotong University

Xian, Shanxi, 710061, China

RECRUITING

Sichuan Cancer Hospita

Chengdu, Sichuan, 610042, China

RECRUITING

Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, 646000, China

RECRUITING

Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, 646000, China

RECRUITING

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Central Study Contacts

Beihua Kong, Doctor

CONTACT

18560081888; kongbeihua@sdu.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: September 26, 2021
• First Posted: October 6, 2021
• Study Start: December 9, 2021
• Primary Completion: May 1, 2023
• Study Completion: July 1, 2023
• Last Updated: December 13, 2021

Record last verified: 2021-12

Locations

CN (17)