A Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of TQB3912 Tablets in Combination With Fulvestrant Injection± TQB3616 Capsules in Patients With Locally Advanced or Metastatic HR-positive and HER2-negative Breast Cancer.

Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

This trial was designed to evaluate the maximum tolerated dose (MTD) and phase II recommended dose (RP2D) in subjects with TQB3912 tablets combined with fulvestrant injection and TQB3616 capsules for locally advanced or metastatic HR-positive and HER2-negative breast cancer.And the effectiveness of TQB3912 tablets combined with fulvestrant injection ±TQB3616 capsules in locally advanced or metastatic HR-positive and HER2-negative breast cancer subjects was evaluated by evaluating ORR, PFS, DOR, DCR, CBR, OS, etc., and at the same time, Assess its safety and pharmacokinetic (PK) characteristics.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• The subjects voluntarily joined the study, signed an informed consent form, and had good compliance.

• Age: 18-75 years old; Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score: 0\

⁃ 1 point; estimated survival time exceeds 3 months.

• Women can be in the late period of menopause and before menopause/innerspring. If they are before menopause/siege period, they must continue to receive ovarian function inhibitory treatment during the research period to enter the group.

• Anthropologically confirmed HR-positive and HER2-negative breast cancer.

• Locally advanced or metastatic diseases that cannot undergo radical surgery.

• Queue 1 Previous treatment requirements: progress after endocrine therapy; Queue 2 Previous treatment requirements: progress after endocrine therapy.

• Have one or more phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA)/v-akt murine thymoma viral oncogene homolog 1 (AKT1)/phosphatase and tensin homolog deleted on chromosome ten (PTEN) gene mutations.

• At least one measurable lesion exists according to the RECIST 1.1 standard.

• Good function of the main organs

• Female subjects of childbearing age should agree that contraceptive measures (such as Buds, contraceptives or condoms) must be used during the study period and within 6 months after the study ends; the serum pregnancy test is negative within 7 days before the study enrollment. , and must be non-lactation subjects; male subjects should agree to adopt contraceptive measures within 6 months after the end of the study period.

Locations
Other Locations
China
The First Affiliated Hospital of Bengbu Medical College
NOT_YET_RECRUITING
Bengbu
Fuzhou First General Hospital
NOT_YET_RECRUITING
Fuzhou
Guizhou Medical University Affiliated Cancer Hospital Co., Ltd
NOT_YET_RECRUITING
Guiyang
Guizhou Provincial People's Hospital
NOT_YET_RECRUITING
Guiyang
Harbin Medical University Cancer
RECRUITING
Harbin
Meizhou peoples Hospital
NOT_YET_RECRUITING
Meizhou
Ningbo Medical Center Lihuili Hospital
NOT_YET_RECRUITING
Ningbo
Quanzhou First Hospital
NOT_YET_RECRUITING
Quanzhou
Liaoning Cancer Hospital
NOT_YET_RECRUITING
Shenyang
Shanxi Cancer Hospital
NOT_YET_RECRUITING
Taiyuan
Taizhou Central Hospital (Taizhou University Affiliated Hospital)
NOT_YET_RECRUITING
Taizhou
Tianjin Cancer Hospital Airport Hospital
NOT_YET_RECRUITING
Tianjin
Tianjin Medical University Cancer Institute & Hospital
NOT_YET_RECRUITING
Tianjin
Xinjiang Medical University Affiliated Cancer Hospital
NOT_YET_RECRUITING
Ürümqi
Zhongnan Hospital of Wuhan University
NOT_YET_RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiao Tong University
NOT_YET_RECRUITING
Xi'an
Yongzhou Central Hospital
NOT_YET_RECRUITING
Yongzhou
Contact Information
Primary
Quchang Ouyang, Doctor
oyqc1969@126.com
0731-89762160
Time Frame
Start Date: 2025-05-16
Estimated Completion Date: 2027-04
Participants
Target number of participants: 75
Treatments
Experimental: TQB3912 tablets in combination with fulvestrant injection± TQB3616 capsules
TQB3912 tablets 120 mg quaque die (QD), + fulvestrant injection 500 mg quaque 4 week(Q4W) (C1D15),28 days as a treatment cycle. Or TQB3912 tablets 120 mg quaque die(QD)+TQB3616 capsules 80 mg/120 mg QD +fulvestrant injection 500 mg quaque 4 week(Q4W) (C1D15), 28 days as a treatment cycle.
Related Therapeutic Areas
Sponsors
Leads: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

This content was sourced from clinicaltrials.gov

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