Breast CancerPhase 1NCT03471663
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
A Phase 1 study testing D-0502 and palbociclib in people with Breast Cancer, run by InventisBio Co., Ltd at 15 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- D-0502 and palbociclib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 18 Mar 2018to 18 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically-proven, ER-positive, HER2-negative locally advanced, inoperable, and/or metastatic breast cancer.
- Female patients with menopausal status:
- Postmenopausal status defined as meeting at least one of the following criteria:
- Have undergone a bilateral oophorectomy any time in life;
- Age ≥60 years, or
- 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]).
Show all 12Show fewer
- 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.
- Patients meeting all the following criteria:
- Has had at least 6 months of endocrine therapy for metastatic ER+ breast cancer prior to disease progression;
- Limited number of prior chemotherapy, endocrine therapy, and targeted therapy for advanced or metastatic disease
- Radiological or objective evidence of disease progression on or after the last systemic therapy prior to starting current study treatment.
- For phase Ia: Not eligible for standard therapy that would confer clinical benefit to the patient.
Who cannot join
- Patients with prior anticancer or investigational drug treatment within the following windows are excluded:
- Participants with prior anticancer or investigational drug treatment within the following windows are excluded:
- Any anti-cancer therapy (including endocrine therapy, chemotherapy, targeted therapy, etc.) less than 30 days before first dose of study treatment.
- Any investigational drug therapy less than 28 days or 4 half-lives (whichever is shorter) prior to first dose of study treatment.
- Patients with untreated or symptomatic or progressive central nervous system (CNS) metastases.
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States11 sites
Local Institution
Aurora, Colorado, 80012
Local Institution
Boston, Massachusetts, 02114
Local Institution
Dallas, Texas, 75246
Local Institution
Eugene, Oregon, 97401
Local Institution
Fresno, California, 93720
Local Institution
Greenville, South Carolina, 29605
Local Institution
Nashville, Tennessee, 37203-1619
Local Institution
New Haven, Connecticut, 06511
Local Institution
San Antonio, Texas, 78217
Local Institution
San Antonio, Texas, 78229
Local Institution
Tyler, Texas, 75702
China4 sites
Local Institution
Beijing, Chaoyang District, 100021
Local Institution
Changsha, Hunan Provence
Local Institution
Guangzhou, Guangdong
Local Institution
Shenyang, Liaoning, 110042
About this study
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
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
- Being tested
- D-0502, palbociclib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-0502Drug
oral tablets
palbociclibDrug
standard dose of palbociclib
| Study group | Role | What they receive |
|---|---|---|
| D-0502 | Experimental | D-0502 Receives: Drug: D-0502 |
| D-0502 in combination with palbociclib | Experimental | D-0502 in combination with palbociclib Receives: Drug: D-0502; Drug: palbociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs meeting protocol defined dose-limiting toxicities (DLTs) criteria
Measured: Approximately 2 years
Secondary outcomes (5)
Maximum observed serum concentration (Cmax)
Measured: Cycle 1 (28 days)
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Measured: Cycle 1 (28 days)
Time of maximum observed concentration (Tmax)
Measured: Cycle 1 (28 days)
Objective response rate (ORR)
Measured: up to 12 months
Progression free survival (PFS)
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start18 Mar 2018
- Primary completion18 Oct 2023
- Study completion18 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- InventisBio Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471663
- Sponsor's protocol ID
- IBIO-301
- Status last verified
- Jan 2024
- First submitted
- 14 Mar 2018
- Last updated
- 8 Jan 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03471663
- Acronym / sponsor ID
- IBIO-301
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- InventisBio Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2018 (actual)
- Primary completion
- 18 Oct 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 20 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-0502 | Experimental | Drug: D-0502D-0502 |
| D-0502 in combination with palbociclib | Experimental | Drug: D-0502, Drug: palbociclibD-0502 in combination with palbociclib |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically-proven, ER-positive, HER2-negative locally advanced, inoperable, and/or metastatic breast cancer.
- Female patients with menopausal status:
- Patients meeting all the following criteria:
Key exclusion criteria (6 listed)
- Patients with prior anticancer or investigational drug treatment within the following windows are excluded:
- Participants with prior anticancer or investigational drug treatment within the following windows are excluded:
- Patients with untreated or symptomatic or progressive central nervous system (CNS) metastases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-0502oral tablets | Drug | D-0502, D-0502 in combination with palbociclib |
| palbociclibstandard dose of palbociclib | Drug | D-0502 in combination with palbociclib |
Primary outcome
Incidence of AEs meeting protocol defined dose-limiting toxicities (DLTs) criteria
Time frame: Approximately 2 years
5 secondary outcomes
Maximum observed serum concentration (Cmax)
Time frame: Cycle 1 (28 days)
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)
Time of maximum observed concentration (Tmax)
Time frame: Cycle 1 (28 days)
Objective response rate (ORR)
Time frame: up to 12 months
Progression free survival (PFS)
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing D-0502 and palbociclib in people with Breast Cancer, run by InventisBio Co., Ltd at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AEs meeting protocol defined dose-limiting toxicities (DLTs) criteria (time frame: Approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.