Status:
COMPLETED
A First-in-Human Study of D-0502 Alone and in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer
Lead Sponsor:
InventisBio Co., Ltd
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
This is a phase I, open-label study of D-0502 single agent and D-0502 in combination with standard dose of palbociclib to assess the safety and tolerability, identify an MTD, and/or RP2D, evaluate the...
Eligibility Criteria
Inclusion
- Histologically-proven, ER-positive, HER2-negative locally advanced, inoperable, and/or metastatic breast cancer.
- Female patients with menopausal status:
- i. Postmenopausal status defined as meeting at least one of the following criteria:
- Have undergone a bilateral oophorectomy any time in life;
- Age ≥60 years, or
- Age \<60 years but have cessation of regular menses ≥12 months with follicle stimulating hormone (FSH) value \>40 milli-international units per milliliter (mIU/mL) and an estradiol value \<40 picograms per milliliter (pg/mL) (140 picomoles per liter \[pmol/L\]).
- ii. Premenopausal or perimenopausal concurrently given a luteinizing hormone-releasing hormone (LHRH) agonist starting at least 4 weeks before the start of trial therapy and is planned to continue LHRH agonist during the study.
- Patients meeting all the following criteria:
- Has had at least 6 months of endocrine therapy for metastatic ER+ breast cancer prior to disease progression;
- Limited number of prior chemotherapy, endocrine therapy, and targeted therapy for advanced or metastatic disease
- Radiological or objective evidence of disease progression on or after the last systemic therapy prior to starting current study treatment.
- For phase Ia: Not eligible for standard therapy that would confer clinical benefit to the patient.
Exclusion
- Patients with prior anticancer or investigational drug treatment within the following windows are excluded:
- Participants with prior anticancer or investigational drug treatment within the following windows are excluded:
- Any anti-cancer therapy (including endocrine therapy, chemotherapy, targeted therapy, etc.) less than 30 days before first dose of study treatment.
- Any investigational drug therapy less than 28 days or 4 half-lives (whichever is shorter) prior to first dose of study treatment.
- Patients with untreated or symptomatic or progressive central nervous system (CNS) metastases.
- Other protocol defined inclusion/exclusion criteria could apply
Key Trial Info
Start Date :
March 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03471663
Start Date
March 18 2018
End Date
October 18 2023
Last Update
January 8 2024
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Local Institution
Fresno, California, United States, 93720
2
Local Institution
Aurora, Colorado, United States, 80012
3
Local Institution
New Haven, Connecticut, United States, 06511
4
Local Institution
Boston, Massachusetts, United States, 02114