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.
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
Interventions
Drug | Synonyms | Arms |
---|
D-0502 | | D-0502 |
palbociclib | | D-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
Name | Type | Description | Interventions |
---|
D-0502 | Experimental | D-0502 | |
D-0502 in combination with palbociclib | Experimental | D-0502 in combination with 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. 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
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: | Recruiting |
Lead Sponsor: | InventisBio Inc. |
Last Updated
June 18, 2021