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This study includes single agent/combination dose exploration study and the phase II study. The primary purpose of the dose exploration study is to determine the maximum tolerated dose(MTD)/recommended phase II dose(RP2D) of XZP-3287 and assess its safety and preliminary efficacy in solid tumor patients. The phase II study aims to explore the efficacy and safety profiles of XZP-3287 as a single- agent in hormone receptor(HR) positive, human epidermal growth factor receptor 2(HER2) negative advanced breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation and Expansion Study | Experimental | To determine the MTD and RP2D of XZP-3287 |
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| Combination Therapy Study | Experimental | To determine the RP2D of XZP-3287 combined with endocrine therapy |
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| A Phase 2 Study of Single-Agent XZP-3287 in Patients After Failure of Multi-Line Therapy | Experimental | To determine the efficacy and safety profiles of XZP-3287 as a single- agent in hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative advanced breast cancer |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XZP-3287 | Drug |
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| |
| Measure | Description | Time Frame |
|---|---|---|
| Single agent and combination dose exploration study:AE evaluation | AEs as characterized by frequency and severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.03 for single agent dose exploration study and CTCAE 5.0 for combination exploration study) | Up to 30 days after the end of treatment |
| The phase II study:Objective response rate (ORR) assessed by Independent Review Committee (IRC) | ORR is the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) as defined by RECIST v1.1. | From baseline to the date of first documentation of progression or death , whichever came first, assessed approximately up to 2 years after the last entered participant |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | PFS is defined as the time from the date of the first treatment until first observation of objective progressive disease or death, whichever comes first. | From baseline to the date of first documentation of progression or death, whichever came first, assessed approximately up to 2 years after the last entered participant |
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Inclusion Criteria:
Combination dose exploration study:Patients with locally advanced or metastatic breast cancer with hormone receptor positive (HR+) and her2-negative (HER2-) were not eligible for surgical resection or radiotherapy for the purpose of cure, and had no clinical indications for chemotherapy, and received endocrine therapy ≤1 line.
The phase II study: Locally advanced or metastatic breast cancer diagnosed histologically or cytologically not suitable for surgery or radical radiotherapy; HR+ and HER2- ; have locally advanced disease not amenable to curative treatment by surgery or metastatic disease; progress after previous endocrine therapy; at least 1 chemotherapy regimen in the previous adjuvant or metastasis contains paclitaxel; there should be at least 2 prior chemotherapy regimens;
Exclusion Criteria:
The phase II study:Have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41063198 | Derived | Wang J, Sun T, Tong Z, Hu X, Li W, Yan M, Liu Y, Ouyang Q, Liu X, Fang J, Li H, Li H, Chen W, Gong C, Teng Y, Xu L, Duan X, Liu M, Meng Y, Liu F, Wang L, Xu B. Safety and tolerability of bireociclib for the treatment of advanced solid tumors as monotherapy and in combination with endocrine therapy: a multicenter, open-label, phase 1 clinical trial. BMC Med. 2025 Oct 8;23(1):546. doi: 10.1186/s12916-025-04364-9. | |
| 40013319 |
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| XZP-3287;Letrozole;Anastrozole;Fulvestrant |
| Drug |
XZP-3287: 360 mg BID, oral; Letrozole: 2.5 mg QD, oral; Anastrozole: 1 mg QD, oral; Fulvestrant: 500 mg intramuscular injection on C1D1, C1D15, the first day of each subsequent cycle (28 days a cycle) |
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| XZP-3287 | Drug | 480 mg BID, oral |
|
| Overall survival (OS) | OS is defined from the date of the first treatment to the date of death from any cause. | From baseline to the death from any cause, assessed approximately up to 2 years after the last entered participant |
| Duration of response (DoR) | DoR is defined from the date of CR or PR to date of disease progression or death due to any cause. | From baseline to the date of first documentation of progression or death, whichever came first, assessed approximately up to 2 years after the last entered participant |
| Disease control rate (DCR) | DCR is the percentage of participants with a best overall response of CR, PR or stable disease (SD) as defined by RECIST v1.1. | From baseline to the date of first documentation of progression or death, whichever came first, assessed approximately up to 2 years after the last entered participant |
| Clinical benefit rate (CBR) | Percentage of participants with best overall response of CR, PR, or SD with duration of SD for at least 6 Months. | From baseline to the date of first documentation of progression or death, whichever came first, assessed approximately up to 2 years after the last entered participant |
| Pharmacokinetics (PK) | Mean steady state exposure of XZP-3287 and its metabolites. | From baseline up to month 3 |
| Investigator-assessed ORR | ORR is the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) as defined by RECIST v1.1. | From baseline to the date of first documentation of progression or death, whichever came first, assessed approximately up to 2 years after the last entered participant |
| The phase II study:AE evaluation | AEs as characterized by frequency and severity (as graded by CTCAE 5.0 ) | Up to 30 days after the end of treatment |
| Derived |
| Wang J, Zhang Q, Sun T, Li H, Cheng Y, Tong Z, Li H, Li W, Wang J, Teng Y, Wu X, Cheng J, Chen Z, Zhu Z, Wang L, Liu M, Duan X, Xu L, Xu B. An open-label, single-arm, multicenter, phase II trial of bireociclib as monotherapy for heavily pretreated HR-positive, HER2-negative advanced breast cancer patients: BRIGHT-1 trial. Cancer Commun (Lond). 2025 Jun;45(6):640-653. doi: 10.1002/cac2.70009. Epub 2025 Feb 27. |