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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03471663
• Other study ID #: IBIO-301
• Status: Completed
• Phase: Phase 1
• Start date: March 18, 2018
• Est. completion date: October 18, 2023

Study information

• Verified date: January 2024
• Source: InventisBio Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 18, 2023
• Est. primary completion date: October 18, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histologically-proven, ER-positive, HER2-negative locally advanced, inoperable, and/or metastatic breast cancer.

2. Female patients with menopausal status:

i. Postmenopausal status defined as meeting at least one of the following criteria:

1. Have undergone a bilateral oophorectomy any time in life;

2. Age =60 years, or

3. 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.

3. Patients meeting all the following criteria:

1. Has had at least 6 months of endocrine therapy for metastatic ER+ breast cancer prior to disease progression;

2. Limited number of prior chemotherapy, endocrine therapy, and targeted therapy for advanced or metastatic disease

3. Radiological or objective evidence of disease progression on or after the last systemic therapy prior to starting current study treatment.

4. For phase Ia: Not eligible for standard therapy that would confer clinical benefit to the patient.

Exclusion Criteria:

1. Patients with prior anticancer or investigational drug treatment within the following

windows are excluded:

2. Participants with prior anticancer or investigational drug treatment within the

following windows are excluded:

1. Any anti-cancer therapy (including endocrine therapy, chemotherapy, targeted therapy, etc.) less than 30 days before first dose of study treatment.

2. Any investigational drug therapy less than 28 days or 4 half-lives (whichever is shorter) prior to first dose of study treatment.

3. Patients with untreated or symptomatic or progressive central nervous system (CNS) metastases.

• Other protocol defined inclusion/exclusion criteria could apply

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• D-0502
oral tablets
• palbociclib
standard dose of palbociclib

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
InventisBio Co., Ltd

Countries where clinical trial is conducted

United States,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of AEs meeting protocol defined dose-limiting toxicities (DLTs) criteria		Approximately 2 years
Secondary	Maximum observed serum concentration (Cmax)		Cycle 1 (28 days)
Secondary	Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]		Cycle 1 (28 days)
Secondary	Time of maximum observed concentration (Tmax)		Cycle 1 (28 days)
Secondary	Objective response rate (ORR)		up to 12 months
Secondary	Progression free survival (PFS)		up to 12 months