AzTrials
AzTrials

Advanced Cervical CancerPhase 1NCT05068921

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

A Phase 1 study testing TQB2858 injection in people with Advanced Cervical Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 17 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

A phase I clinical trial of tolerability and pharmacokinetics of TQB2858 injection in subjects with advanced malignancy. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Advanced Cervical Cancer
What is being tested?
TQB2858 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
17 sitesChina
Study dates
9 Dec 2021to Jul 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1) All the following conditions were met for the corresponding study stage:
  • 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;
  • 2) Aged: 18 ~ 75 years old
  • 3)Physical condition score( Eastern Cooperative Oncology Group(ECOG) score): 0~1
  • 4) estimated survival time ≥ 3 months
  • 5)The main organs function well and meet the following standards:
Show all 9Show fewer
  • 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%;
  • 6) 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;
  • 7）The subjects voluntarily joined the study, signed the informed consent form, and had good compliance.

Who cannot join

  • 1) 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;
Show all 23Show fewer
  • 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 hepatitis (hepatitis B reference:Hepatitis B surface antigen( HBsAg )positive, and Hepatitis B virus DNA(HBV DNA)>2500 copies /mL or > 500 IU/mL; Hepatitis C reference: hepatitis C virus(HCV) antibody positive, and HCV virus titer test value exceeds the upper limit of normal value); Note: Subjects with positive surface antigen of hepatitis B or positive core antibody and hepatitis C patients eligible for inclusion are advised to continue antiviral therapy to prevent virus activation;
  • Active syphilis and active tuberculosis;
  • Renal failure requiring hemodialysis or peritoneal dialysis: glomerular filtration rate(eGFR) < 15ml/ (min•1.73㎡);
  • A history of immunodeficiency, including Human Immunodeficiency Virus(HIV )positive or other acquired or congenital immunodeficiency disease, or a history of organ transplantation;
  • Poor control of diabetes (Fasting blood glucose (FBG) > 10mmol/L, bedtime blood glucose > 11.1mmol/L and hemoglobin A1C (HbA1c) ≥8.5% before bedtime);
  • Patients with urine protein ≥++ as indicated by routine urine examination, and 24-hour urine protein quantity > 1.0g;
  • Persons suffering from epilepsy and requiring medical treatment.
  • 2) Tumor-related symptoms and treatment: a) Received surgery, chemotherapy, radiation or other anticancer therapy within 4 weeks before the start of study treatment (the washout period is calculated from the end of the last treatment); Those who had previously received local radiation therapy were eligible to enroll if they met the following criteria: the end of radiotherapy was more than 4 weeks before the start of study therapy (brain radiation was more than 2 weeks); The target lesions selected in this study are not in the radiotherapy region. Or the target lesion is located in the radiotherapy area, but progression is confirmed. b) Received the treatment of Chinese patent medicines with anti-tumor indications specified in the National Medical Products Administration(NMPA) approved drug instructions (including compound cantharidin capsules, Kangai injection, Kanglaite capsule/injection, Aidi injection, brucea javanica oil injection/capsule, Xiaoaiping tablet/injection, Huachansu capsule, etc.) within 2 weeks before the study treatment; c) Previously received immunomodulator therapy, including therapeutic vaccines, cytokine therapy, or Anti-programmed death receptor 1(anti-PD-1), Programmed death ligand-1(PD-L1), Cytotoxic T lymphocyte-associated protein 4(CTLA-4), High purity recombinant protein(4-1BB), T cell activation markers(OX-40) and other related immunotherapy drugs; d) pleural effusion, pericardial effusion, or ascites that uncontrolled and still requires repeated drainage (as determined by the investigator); e) Patients with brain metastasis whose symptom control stabilizes for less than 4 weeks after withdrawal of dehydrants and steroids (only for stage 2 patients with previous central nervous system metastases).
  • 3) Research treatment related: a) history of live attenuated vaccine administration within 28 days before the start of study treatment or planned live attenuated vaccine administration during the study period; b) Have a history of severe allergy to macromolecule drugs or known components of TQB2858 injection; c) An active autoimmune disease requiring systemic treatment (such as palliative drugs, corticosteroids, or immunosuppressants) occurred within 2 years before the start of study therapy. Alternative therapies (such as thyroxine, insulin, or physical corticosteroids for adrenal or pituitary dysfunction, etc.) are not considered systemic treatment; d) diagnosed as immunodeficient or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy (dose >10mg/ d of prednisone or other equivalent hormone) and continued use within 2 weeks of initial administration; e) Participated in clinical trials of other antitumor drugs within 4 weeks before grouping.
  • 4) According to the researcher's judgment, subjects who have concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or who are considered unsuitable for inclusion for other reasons.

Trial locations and contacts

17 sites in 1 country.

Beihua Kong, Doctor contact

18560081888

kongbeihua@sdu.edu.cn

17 sites in 1 country

China17 sites, 17 recruiting

  • Affiliated Hospital of Changchun University of Chinese Medicine

    Changchun, Jilin, 130000

    Jing Xuan, Doctor, 15543091156, 3088557008@qq.com

    Recruiting

  • Hunan Cancer Hospita

    Changsha, Hunan, 410013

    Jing Wang, Doctor, 13875902083, wangjing0081@126.com

    Recruiting

  • Affiliated Peace Hospital of Changzhi Medical College

    Changzhi, Shanxi, 046000

    Jianjun Wu, Bachelor, 13935593759, rbt2001@163.com

    Recruiting

  • Sichuan Cancer Hospita

    Chengdu, Sichuan, 610042

    Yan Tan, Doctor, 13880970403, 26316295@qq.com

    Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

    Beihua Kong, Doctor, 18560081888, kongbeihua@sdu.edu.cn

    Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

    Youzhong Zhang, Doctor, 18560081866, zyz13791122638@126.com

    Recruiting

  • Linyi Tumor Hospital

    Linyi, Shandong, 276000

    Xiumin Li, Doctor, 13583991399, Lyzlyylxm@163.com

    Recruiting

  • Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan, 646000

    Qinlian Wen, Doctor, 13518388130, wql73115@163.com

    Recruiting

  • Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan, 646000

    Qing Peng, Doctor, 15984007875, pq9712118@163.com

    Recruiting

  • Affiliated Tumor Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

    Li Li, Doctor, 13878113406, Lili@gxmu.edu.cn

    Recruiting

  • Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266001

    Xiaochun Zhang, Doctor, 18661801679, zxc9670@126.com

    Recruiting

  • Qingdao Central Hospital

    Qingdao, Shandong, 266042

    Li Sun, Doctor, 18953109686, sunli766@163.com

    Recruiting

  • The Third Affiliated Hospital of Qiqihar Medical College

    Qiqihar, Heilongjiang, 161099

    Xu Dong, Master, 138 4523 1139, cn_tongxu@163.com

    Recruiting

  • The Second Affiliated Hospital of Shandong First Medical University

    Taian, Shandong, 271099

    Haiyan Liu, Master, 18505387037, fylhy1998@163.com

    Recruiting

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 300060

    Ke Wang, Master, 18622221098, 18622080116@163.com

    Recruiting

  • The First Affiliated Hospital of Xi 'an Jiaotong University

    Xian, Shanxi, 710061

    Zi Liu, Doctor, 13630223132, liuzimail@163.com

    Recruiting

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264099

    Ying Yang, Doctor, 15966506506, hxdany2004@126.com

    Recruiting

Other trials in China

About this study

Official title: Phase I Clinical Trial to Evaluate Tolerability and Pharmacokinetics of TQB2858 Injection in Subjects With Advanced Malignancy

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

Being tested
TQB2858 injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQB2858 injectionDrug

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

Study groups in NCT05068921
Study groupRoleWhat they receive
TQB2858ExperimentalTQB2858 injection: once every 3 weeks, 1800mg each time, intravenous infusion. Until the disease progression or unbearable adverse events occur.
Receives: Drug: TQB2858 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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) .

    Measured: Baseline to up to two years

Secondary outcomes (5)

  1. Progress Free Survival(PFS)

    The period from the first use of the drug to disease progression or death (whichever occurs first)

    Measured: Baseline to up to two years

  2. Disease Control Rate(DCR)

    Proportion of subjects whose tumors shrink or remain stable for a certain period, including complete remission（CR）, partial remission（PR） and stable disease（SD）

    Measured: Baseline to up to two years

  3. Duration of Response(DOR)

    The period from firstly-recorded objective tumor response (CR or PR) to firstly-recorded objective tumor progression or death due to any cause (whichever occurs first) .

    Measured: Baseline to up to two years

  4. Overall Survival(OS)

    The period from the first use of the drug to death from all causes. For subjects who are still alive at the last follow-up, the OS will be counted as data censored based on the last follow-up. For subjects who are lost follow-up, the OS will be counted as data censored based on the last confirmed survival time before being lost to follow-up.

    Measured: Baseline to up to two years

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

    Adverse events refer to all adverse medical events that occur after a patient or clinical trial subject receives an experimental drug, which can be expressed as symptoms, signs, diseases, or abnormalities in laboratory tests, but are not necessarily related to the treatment of the experimental drug. Serious adverse events refer to adverse medical conditions such as death, life threatening, permanent or severe disability, loss of function, the need for hospitalization or prolonged hospitalization , and congenital abnormalities or birth defects after the subject receives the experimental drug.

    Measured: Baseline to up to two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2021
  2. Study start9 Dec 2021
  3. Primary completionMay 2023 (estimated)
  4. Study completionJul 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05068921
Sponsor's protocol ID
TQB2858-Ⅰ-06
Status last verified
Dec 2021
First submitted
26 Sep 2021
Last updated
13 Dec 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TQB2858 injection in people with Advanced Cervical Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 17 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Beihua Kong, Doctor (18560081888, kongbeihua@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rates (ORR) (time frame: Baseline to up to two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05068921.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in