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

NCT05416359 | Unknown Phase 1

• 1 other identifier: TQB3915-I-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Advanced Malignant Tumor

Outcome Measures

Primary Outcomes (3)

• Dose-limiting toxicity (DLT)

  The following adverse events related to the trial drug occurred within 1 treatment cycle (34 days) of the subject's first dose

  up to 7 months

• Maximum Tolerated Dose (MTD)

  The MTD was the previous dose at which the following toxicities occurred

  up to 7 months

• Recommended Phase II Dose (RP2D)

  To evaluate RP2D of TQB3915 Tablets in patients with advanced malignant tumors

  up to 7 months

Secondary Outcomes (19)

• Adverse Events (AEs), Serious Adverse Events (SAEs) and Treatment-Related Adverse Events (TRAEs)

  up to 18 months

• Time to reach maximum(peak )plasma concentration following drug administration (Tmax)

  up to 18 months

• Maximum (peak) plasma drug concentration (Cmax)

  up to 18 months

• Elimination half-life (t1/2)

  up to 18 months

• Area under the plasma concentration-time curve from time zero to infinity(AUC0-∞)

  up to 18 months

Study Arms (1)

TQB3915 tablets

EXPERIMENTAL

Take 300mg, 450mg, 600mg, 750mg, 900mg each time, once a day;Oral administration on an empty stomach, 28 days as a cycle. Duration of medication: Continue medication until disease progression or intolerable toxicity occurs.

Drug: TQB3915 tablets

Interventions

TQB3915 tablets DRUG

TQB3915 binds to estrogen receptors through covalent bonds, and blocks intracellular signal transmission by changing the conformation of ERα, thereby inhibiting the growth of tumor cells.

TQB3915 tablets

Eligibility Criteria

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

You may qualify if:

• 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;

You may not qualify if:

• 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);

Sponsors & Collaborators

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

Study Sites (3)

Sun Yat-Sen University Cancer Canter

Guangzhou, Guangdong, 510060, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

First Affiliated Hospital with Nanjin Medical University (Jiangsu Province Hospital)

Nanjing, Jiangsu, 210029, China

RECRUITING

Central Study Contacts

Yongmei p Yin, Doctor

CONTACT

17818528960; ym.yin@hotmail.com

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: June 9, 2022
• First Posted: June 13, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2024
• Last Updated: June 13, 2022

Record last verified: 2022-06

Locations

CN (3)