A Phase I, Open-Label Study of D-0502 Single Agent and D-0502 in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer
- Study HIC#:2000025405
- Last Updated:01/06/2021
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 PK properties and evaluate preliminary anti-tumor activities in women with advanced or metastatic ER-positive, HER2-negative breast cancer.
- Start Date02/19/2020
- End Date04/02/2021
Trial Purpose and Description
Primary Outcome Measures :
- Incidence of AEs meeting protocol defined dose-limiting toxicities (DLTs) criteria [ Time Frame: Approximately 2 years ]
Secondary Outcome Measures :
- Maximum observed serum concentration (Cmax) [ Time Frame: Cycle 1 (28 days) ]
- Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] [ Time Frame: Cycle 1 (28 days) ]
- Time of maximum observed concentration (Tmax) [ Time Frame: Cycle 1 (28 days) ]
- Objective response rate (ORR) [ Time Frame: up to 12 months ]
- Progression free survival (PFS) [ Time Frame: up to 12 months ]
- 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;
- Receipt of ≤ 2 lines of prior chemotherapy for 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.
- Patients with prior anticancer or investigational drug treatment within the following windows are excluded:
- Tamoxifen therapy less than 6 weeks before first dose of study treatment.
- For phase Ib: fulvestrant or other selective estrogen receptor degraders (SERD) such as RAD1901, AZD9496, LSZ102, GDC0927 and H3B-6545 therapy less than 6 months before first dose of study treatment.
- Any other anti-cancer endocrine therapy less than 30 days before first dose of study treatment.
- Any other investigational drug therapy less than 28 days or 4 half-lives (whichever is longer) or non-resolved toxicity such hematology issue prior to first dose of study treatment.
- Patients with untreated or symptomatic or progressive central nervous system (CNS) metastases.
- Patients with endometrial disorders, including evidence of endometrial hyperplasia, dysfunctional uterine bleeding or cysts.
- Other protocol defined inclusion/exclusion criteria could apply