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

Completed · Phase 1

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT03471663

Run by

InventisBio Co., Ltd

People needed

200

Starts

2018-03-18

Expected to finish

2023-10-18

Last updated by the study team

2024-01-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Local Institution — Fresno, California, United States
• Local Institution — Aurora, Colorado, United States
• Local Institution — New Haven, Connecticut, United States
• Local Institution — Boston, Massachusetts, United States
• Local Institution — Eugene, Oregon, United States
• Local Institution — Greenville, South Carolina, United States
• Local Institution — Nashville, Tennessee, United States
• Local Institution — Dallas, Texas, United States
• Local Institution — San Antonio, Texas, United States
• Local Institution — San Antonio, Texas, United States
• Local Institution — Tyler, Texas, United States
• Local Institution — Beijing, Chaoyang District, China
• Local Institution — Guangzhou, Guangdong, China
• Local Institution — Changsha, Hunan Provence, China
• Local Institution — Shenyang, Liaoning, China

Full record on ClinicalTrials.gov

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