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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03471663
Recruitment Status : Active, not recruiting
First Posted : March 20, 2018
Last Update Posted : May 6, 2022
Information provided by (Responsible Party):
InventisBio Co., Ltd

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: D-0502 Drug: palbociclib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 18, 2018
Actual Primary Completion Date : October 29, 2021
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Palbociclib

Arm Intervention/treatment
Experimental: D-0502
Drug: D-0502
oral tablets

Experimental: D-0502 in combination with palbociclib
D-0502 in combination with palbociclib
Drug: D-0502
oral tablets

Drug: palbociclib
standard dose of palbociclib

Primary Outcome Measures :
  1. Incidence of AEs meeting protocol defined dose-limiting toxicities (DLTs) criteria [ Time Frame: Approximately 2 years ]

Secondary Outcome Measures :
  1. Maximum observed serum concentration (Cmax) [ Time Frame: Cycle 1 (28 days) ]
  2. 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) ]
  3. Time of maximum observed concentration (Tmax) [ Time Frame: Cycle 1 (28 days) ]
  4. Objective response rate (ORR) [ Time Frame: up to 12 months ]
  5. Progression free survival (PFS) [ Time Frame: up to 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03471663

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United States, California
Local Institution
Fresno, California, United States, 93720
United States, Colorado
Local Institution
Aurora, Colorado, United States, 80012
United States, Connecticut
Local Institution
New Haven, Connecticut, United States, 06511
United States, Massachusetts
Local Institution
Boston, Massachusetts, United States, 02114
United States, Oregon
Local Institution
Eugene, Oregon, United States, 97401
United States, South Carolina
Local Institution
Greenville, South Carolina, United States, 29605
United States, Tennessee
Local Institution
Nashville, Tennessee, United States, 37203-1619
United States, Texas
Local Institution
Dallas, Texas, United States, 75246
Local Institution
San Antonio, Texas, United States, 78217
Local Institution
San Antonio, Texas, United States, 78229
Local Institution
Tyler, Texas, United States, 75702
China, Chaoyang District
Local Institution
Beijing, Chaoyang District, China, 100021
China, Guangdong
Local Institution
Guangzhou City, Guangdong, China
China, Hunan Provence
Local Institution
Changsha City, Hunan Provence, China
China, Liaoning
Local Institution
Shenyang City, Liaoning, China, 110042
Sponsors and Collaborators
InventisBio Co., Ltd
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Responsible Party: InventisBio Co., Ltd
ClinicalTrials.gov Identifier: NCT03471663    
Other Study ID Numbers: IBIO-301
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: May 6, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action