Phase I Clinical Trial of TQB3915 Tablets in Subjects With Advanced Malignant Solid Tumors

  • STATUS
    Recruiting
  • End date
    Jun 29, 2024
  • participants needed
    70
  • sponsor
    Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Updated on 29 June 2022

Summary

TQB3915 is a selective estrogen receptor covalent antagonist, by covalently binding to estrogen receptor, by changing the conformation of ERα, blocking intracellular signal transmission, thereby inhibiting the growth of tumor cells.

Details
Condition Advanced Malignant Tumor
Treatment TQB3915 tablets
Clinical Study IdentifierNCT05416359
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.
Last Modified on29 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects voluntarily join the study and sign an informed consent form
Age: 18-75 years old (when signing the informed consent form); Eastern Cooperative Oncology Group Performance status (ECOG PS) score: 0~1 points; Ected survival more than 3 months
Advanced malignant tumors clearly diagnosed by histology or cytology
According to RECIST 1.1 criteria, it is confirmed that there is at least one measurable lesion
The main organs are in good function
Female subjects of childbearing age should agree to use contraceptive measures during the study period and within 6 months after the end of the study

Exclusion Criteria

Concomitant diseases and medical history
The previous pathological test was diagnosed as HER2-positive breast cancer
have inflammatory breast cancer
Other malignant tumors have occurred or are currently concurrently present within 3 years. The following two conditions were eligible for enrollment: other malignancies treated with a single surgery, achieving 5 years of disease-free survival (DFS); cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [ Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor-infiltrating basement membrane)]
There are multiple factors that affect oral medication (such as inability to swallow, acute and chronic diarrhea, and intestinal obstruction, etc.)
Unresolved toxicity of CTC AE grade 1 and above due to any previous treatment, excluding alopecia
Subjects who have undergone major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the study period within 28 days prior to the first dose
wounds or fractures that have not healed for a long time
Those with a bleeding constitution; or suffering from clinically significant bleeding (such as hemoptysis), coagulation disorders, or being treated with antiplatelet/anticoagulants, blood transfusions or platelet transfusions
Have used a strong inhibitor or inducer of CYP3A within 2 weeks before taking the study drug for the first time
Arterial/venous thrombotic events, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, occurred within 6 months before the first drug
Those who have a history of psychotropic substance abuse and cannot quit or have mental disorders
Subjects with any severe and/or uncontrolled disease, including
Poor blood pressure control (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg)
Suffering from grade ≥2 myocardial ischemia or myocardial infarction, arrhythmia (including: QTc ≥450ms for males, QTc ≥470ms for females) and grade ≥2 congestive heart failure (New York Heart Association (NYHA) classification)
Active or uncontrolled serious infection (≥CTC AE grade 2 infection)
Liver cirrhosis; or active hepatitis: hepatitis B reference: HBsAg positive, and HBV DNA detection value exceeds the upper limit of normal; hepatitis C reference: HCV antibody positive, and HCV virus titer detection value exceeds the upper limit of normal; Note: Those who meet the entry conditions, subjects who are positive for hepatitis B surface antigen or core antibody, and subjects with hepatitis C, need to continue antiviral treatment to prevent virus activation
Active syphilis infection
Renal failure requiring hemodialysis or peritoneal dialysis
History of pulmonary interstitial fibrosis, drug-induced interstitial lung disease; or evidence of active pneumonia found on chest CT scan during screening
Those with a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation
Those who suffer from epilepsy and need treatment
Tumor-related symptoms and treatment
Received surgery, chemotherapy, radiotherapy or other anti-cancer therapy within 4 weeks before the first dose (calculated from the end of the last treatment); those who have received local radiotherapy in the past can be included in the group if they meet the following conditions: The study treatment started more than 4 weeks (more than 2 weeks for brain radiotherapy); and the target lesions selected in this study were not in the radiotherapy area; or the target lesions were located in the radiotherapy area, but progress was confirmed
Received NMPA-approved Chinese patent medicines with anti-tumor indications in the drug instructions within 2 weeks before the first administration (including Compound Cantharidin Capsule, Kangai Injection, Kanglaite Capsule/Injection, Aidi Injection, Brucei Oil Injection /capsule, Xiaoaiping tablet/injection, cinobufacin capsule, etc.) treatment
Imaging (CT or MRI) shows that the tumor has invaded around important blood vessels or the investigator judges that the tumor is very likely to invade important blood vessels and cause fatal bleeding during the follow-up study
Uncontrolled pleural effusion, pericardial effusion or ascites that still requires repeated drainage (judgment by the investigator)
Brain metastases, spinal cord compression, cancerous meningitis with clinical symptoms (unless asymptomatic, or treated and stable, no imaging evidence of new brain metastases or brain metastases expansion has been found for at least 2 weeks after treatment for brain metastases , and discontinued steroid or anticonvulsant therapy for at least 14 days prior to initiation of study treatment)
Study treatment related
Vaccination history of live attenuated vaccine within 28 days before the first dose or plan to receive live attenuated vaccine during the study period
Allergic constitution, or known allergy to the active ingredients or excipients of the study drug
Active autoimmune disease requiring systemic therapy (eg, use of disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to initiation of study treatment; alternative therapy (eg, thyroxine, insulin, or adrenal or pituitary therapy) Physiological corticosteroids for insufficiency, etc.) are not considered systemic therapy
Diagnosed with immunodeficiency disease or are receiving systemic glucocorticoid therapy or any other systemic immunosuppressive therapy (dose >10mg/day prednisone or other equivalent therapeutic hormone), and still within 2 weeks before the start of study treatment in continued use
are using drugs known to prolong the QTc interval
is taking a drug known to cause sinus bradycardia
Those who participated in clinical trials of other anti-tumor drugs within 4 weeks
before enrollment or did not exceed 5 drug half-lives
Any factors that increase the risk of QTc interval prolongation or risk of arrhythmia, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained occurrence in first-degree relatives younger than 40 years of age sudden death
Any factors that may increase the risk of sinus bradycardia, such as hyperkalemia, hypothyroidism, etc
According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are considered unsuitable for enrollment for other reasons
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