Active, not recruiting • Phase I • Stage III, IV • ER positive • HER2 negative • Post-Menopausal • Interventional

The following is imported from ClinicalTrials.gov:

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

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 PK properties and evaluate preliminary anti-tumor activities in women with advanced or metastatic ER-positive, HER2-negative breast cancer.

Description

Study Design

Eligibility Criteria

Arms and Intervention

• D-0502

• palbociclib

Inclusion criteria

• 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 criteria

• 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