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

NCT ID: NCT03471663

Last Updated: 2024-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-18
• Study Completion Date: 2023-10-18

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

D-0502

D-0502

Group Type: EXPERIMENTAL

D-0502

Intervention Type: DRUG

oral tablets

D-0502 in combination with palbociclib

D-0502 in combination with palbociclib

Group Type: EXPERIMENTAL

D-0502

Intervention Type: DRUG

oral tablets

palbociclib

Intervention Type: DRUG

standard dose of palbociclib

Interventions

D-0502

oral tablets

Intervention Type: DRUG

palbociclib

standard dose of palbociclib

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

InventisBio Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States; China

Other Identifiers

IBIO-301

Identifier Type: -

Identifier Source: org_study_id