Clinical Trials /

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

NCT03471663

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: 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
  • 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 IDs

  • ORG STUDY ID: IBIO-301
  • NCT ID: NCT03471663

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
D-0502D-0502
palbociclibD-0502 in combination with palbociclib

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
D-0502ExperimentalD-0502
  • D-0502
D-0502 in combination with palbociclibExperimentalD-0502 in combination with palbociclib
  • D-0502
  • palbociclib

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. 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of AEs meeting protocol defined dose-limiting toxicities (DLTs) criteria
Time Frame:Approximately 2 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Maximum observed serum concentration (Cmax)
Time Frame:Cycle 1 (28 days)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure:Time of maximum observed concentration (Tmax)
Time Frame:Cycle 1 (28 days)
Safety Issue:
Description:
Measure:Objective response rate (ORR)
Time Frame:up to 12 months
Safety Issue:
Description:
Measure:Progression free survival (PFS)
Time Frame:up to 12 months
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:InventisBio Inc.

Last Updated

March 19, 2018