Trials Sponsors Conditions Drugs Pricing

Conditions

Advanced Breast Cancer Metastasis Solid Tumors

Outcome Measures

Primary Outcomes (2)

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

Secondary Outcomes (8)

Progression free survival (PFS)
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
Overall survival (OS)
From baseline to the death from any cause, assessed approximately up to 2 years after the last entered participant
Duration of response (DoR)
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)
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)
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

Study Arms (3)

Dose Escalation and Expansion Study

EXPERIMENTAL

To determine the MTD and RP2D of XZP-3287

Drug: XZP-3287

Combination Therapy Study

EXPERIMENTAL

To determine the RP2D of XZP-3287 combined with endocrine therapy

Drug: XZP-3287;Letrozole;Anastrozole;Fulvestrant

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

Interventions

XZP-3287Drug

* 20-560 mg QD, oral * 240-480 mg BID, oral

Dose Escalation and Expansion Study

XZP-3287;Letrozole;Anastrozole;FulvestrantDrug

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)

Combination Therapy Study

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
XZP-3287;Letrozole;Anastrozole;Fulvestrant
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Single agent and combination dose exploration study：Patient is an adult male/female 18\~70 years old; the phase II study：Patient is an adult male/female ≥ 18 years old;
Single agent dose escalation study ：Patients with a histologically or cytologically confirmed diagnosis of a solid tumor for which Standard treatment failure or no further effective standard treatment is available.

Sponsors & Collaborators

Sihuan Pharmaceutical Holdings Group Ltd.
Industrylead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100000, China

Related Publications (2)

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.
PMID: 41063198DERIVED
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.
PMID: 40013319

Enrollment

402 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 26, 2020

First Posted

September 7, 2020

Study Start

May 22, 2018

Actual (reported)

You may not qualify if:

Single agent and combination dose exploration study：Patients with known uncontrolled or symptomatic CNS metastases; The phase II study：Have central nervous system (CNS) metastasis, or Have visceral crisis, or Inflammatory breast cancer.
Have received an autologous or allogeneic stem-cell transplant.
Patient has impairment of gastrointestinal (GI) function or GI disease.
Single agent and combination dose exploration study：Any other malignancy was diagnosed within 3 years prior to enrollment, except for basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix, which is adequately treated and the disease is stable.
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.
Subject has impaired cardiac function or heart disease of clinical significance.
Cerebrovascular accidents within 6 months before enrollment, including a history of transient ischemic attack or stroke.
Major surgery or surgical treatment due to any cause occurred within 4 weeks prior to enrollment.
Presence of any serious and/or uncontrolled disease in the opinion of the investigator that may interfere with the study assessment.
Uncontrollable pleural effusion, peritoneal effusion, pericardial effusion in the 4 weeks before the first administration (except for a small amount of effusion detected by imaging examination).
A prior history of definite neurological or psychiatric disorders, including epilepsy or dementia.
Chronic active HBV, HCV or HIV diseases.
Patient who received any CDK4/6 inhibitor or patients who plan surgery, or the investigator determines that surgery or radical radiation therapy is required.
Participation in a prior treatment of chemotherapy, radiotherapy, endocrinotherapy, targeted therapy, immunotherapy and any investigational study within 14 days prior to enrollment.
Bone marrow suppression therapy, such as GCS-F, EPO, or blood transfusion, was administered within 14 days prior to enrollment.
+2 more criteria

A Phase I/II Study of XZP-3287 in Metastasis Solid Tumors

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (8)

Study Arms (3)

Dose Escalation and Expansion Study

Combination Therapy Study

A Phase 2 Study of Single-Agent XZP-3287 in Patients After Failure of Multi-Line Therapy

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (8)

Study Arms (3)

Dose Escalation and Expansion Study

Combination Therapy Study

A Phase 2 Study of Single-Agent XZP-3287 in Patients After Failure of Multi-Line Therapy

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations