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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

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ClinicalTrials.gov Identifier: NCT03471663
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
InventisBio Inc.

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)
Estimated Enrollment : 57 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
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : October 2021

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
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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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. Receipt of ≤ 2 lines of prior chemotherapy for 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:

    1. Tamoxifen therapy less than 6 weeks before first dose of study treatment.
    2. For phase Ib: fulvestrant or other selective estrogen receptor degraders (SERD) such as RAD1901, AZD9496, LSZ102, GDC0927 and H3B-6545 therapy less than 6 months before first dose of study treatment.
    3. Any other anti-cancer endocrine therapy less than 30 days before first dose of study treatment.
    4. Any other investigational drug therapy less than 28 days or 4 half-lives (whichever is longer) or non-resolved toxicity such hematology issue prior to first dose of study treatment.
  2. Patients with untreated or symptomatic or progressive central nervous system (CNS) metastases.
  3. Patients with endometrial disorders, including evidence of endometrial hyperplasia, dysfunctional uterine bleeding or cysts.

    • 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


Contacts
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Contact: Shi Zhe, PhD 86-21-5003661 zhe.shi@inventisbio.com

Locations
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United States, Colorado
Local Institution Recruiting
Aurora, Colorado, United States, 80012
Contact: Site 105         
United States, Tennessee
Local Institution Recruiting
Nashville, Tennessee, United States, 37203-1619
Contact: Site 102         
United States, Texas
Local Institution Recruiting
Dallas, Texas, United States, 75246
Contact: Site 106         
Local Institution Recruiting
San Antonio, Texas, United States, 78217
Contact: Site 104         
Local Institution Recruiting
Tyler, Texas, United States, 75702
Contact: Site 103         
United States, Washington
Local Institution Recruiting
Tacoma, Washington, United States, 98405-5093
Contact: Site 101         
Sponsors and Collaborators
InventisBio Inc.

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Responsible Party: InventisBio Inc.
ClinicalTrials.gov Identifier: NCT03471663     History of Changes
Other Study ID Numbers: IBIO-301
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019

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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
Neoplasms
Breast Diseases
Skin Diseases
Palbociclib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action