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Advanced Breast CancerPhase 1NCT05337657

A Phase Ib Study of GB491 Plus Letrozole in Patients With Advanced Breast Cancer

A Phase 1 study testing GB491+Letrozole in people with Advanced Breast Cancer, run by Genor Biopharma Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

GB491-005 is a multicenter, open-label, phase Ib Clinical Trial study to evaluate the safety, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of GB491 in combination with Letrozole in Previously Untreated Patients with HR-positive, HER2-negative Advanced Breast Cancer Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Advanced Breast Cancer
What is being tested?
GB491+Letrozole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
2 Jun 2021to 1 Feb 2024
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

  • Females of 18 years of age or older at study screening
  • Histologically or cytologically confirmed locally advanced or advanced metastatic breast cancer that is not amenable to curative surgical resection or radiation therapy
  • The subject has been diagnosed with ER-positive breast cancer in the local laboratory
  • The subject has HER2-negative breast cancer in the local laboratory
  • Menopausal status is not limited (including Premenopausal/perimenopausal/postmenopausal state)
  • No previous systemic anti-tumor treatment for locally advanced or metastatic breast cancer;
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  • According to RECIST V1.1, the patient has at least one measurable lesion that has not been irradiated by radiotherapy and can be evaluated by CT/MRI; If only bone metastases are present, there must be at least one osteolytic bone lesion that can be evaluated by CT/MRI
  • ECOG performance status of 0 or 1
  • Adequate organ and marrow function.
  • The subject of childbearing potential must use one highly effective birth control method from the total duration of the study and 6 months after the last dose of study intervention.
  • Provide informed consent

Who cannot join

  • Previous treatment with CDK4/6 inhibitors
  • Subjects with known hypersensitivity to any component of GB491 or Letrozole
  • Patients with disease progression or recurrence during or within 1 year after completion of previous endocrine neoadjuvant or adjuvant therapy
  • Known active, uncontrolled, or symptomatic central nervous system metastasis, carcinomatous meningitis, or clinically manifested leptomeningeal disease, cerebral edema, spinal compression or/and tumor progressive growth
  • Visceral crisis
  • Patients with skin lesion only and radiographically non-measurable at baseline
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  • Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy, excluding alopecia
  • Major surgical procedure within 4 weeks of the first dose of study treatment or an anticipated need for major surgery, chemotherapy, radiotherapy, any other investigational drug or other anti-cancer therapy during the study
  • Patients who have been on bisphosphonates and denosumab therapy at a stable dose for less than 14 days prior to randomization
  • Patients who have received limited field radiotherapy in 2 weeks or extended field radiotherapy in 4 weeks before randomization or radiation with more than 30% of the bone marrow
  • Subjects use drugs or fruits containing strong inducers or inhibitors of CYP3A4/5, or drugs with narrow therapeutic window that are mainly metabolized by CYP3A4/5 in 14 days before randomization
  • Patients with long-term systematic use of corticosteroids
  • Any severe and/or uncontrollable medical conditions
  • Patients with severely impaired lung function
  • Known history of HIV infection or history of HIV seropositivity
  • Resting QTcF > 480 msec or there is a medical history of QTcF prolongation
  • Subjects have significant hepatic disease
  • Coagulation abnormalities
  • Refractory nausea and vomiting, inability to swallow the formulated product, or other disease or clinical status would preclude adequate absorption, distribution, metabolism, or excretion of GB491
  • Previous allogeneic bone marrow transplant
  • Inflammatory breast cancer;
  • Subjects with a history of other primary malignancies, except for non-melanoma skin cancer and cervical cancer in situ disease-free status ≥ 3 years
  • Lactating women
  • Unlikely to comply with study procedures, restrictions, and requirements
  • Judgment by the investigator that the patient should not participate into the study

Trial locations and contacts

1 site in 1 country.

Shawn Yu contact

021-60751991

shawn.yu@genorbio.com

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Xichun Hu, PhD, 13816110335, xchun2009@hotmail.com

    Jian Zhang, PhD, 18017312991, syner2000@163.com

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Open-label, Phase Ib Clinical Trial of GB491 in Combination With Letrozole in Previously Untreated Patients With HR-positive, HER2-negative Advanced Breast Cancer

GB491-005 is a multicenter, open-label, phase Ib Clinical Trial study to evaluate the safety, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of GB491 in combination with Letrozole in Previously Untreated Patients with HR-positive, HER2-negative Advanced Breast Cancer

Being tested
GB491+Letrozole

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GB491+LetrozoleDrug

    Drug：The dose of GB491 is 150 mg, which should be taken with a meal and taken twice daily at approximately the same time each day, approximately 12 hours apart

Study groups in NCT05337657
Study groupRoleWhat they receive
GB491+LetrozoleExperimentalNot described
Receives: Drug: GB491+Letrozole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DLT

    Number of Participants with Dose-Limiting Toxicities for GB491 in Combination with Letrozole

    Measured: During Cycle 1 (up to 28 days)

  2. AE

    Number of Participants with Adverse Events by Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)

    Measured: From Baseline until 30 days after the last treatment

Secondary outcomes (7)

  1. PFS

    To assess the progression free survival assessed by investigator

    Measured: Approximately 2 years

  2. ORR

    To assess the objective response rate for GB491 in Combination with Letrozole

    Measured: Approximately 2 years

  3. DOR

    To assess the duration of response for GB491 in Combination with Letrozole

    Measured: Approximately 2 years

  4. DCR

    To assess the disease control rate for GB491 in Combination with Letrozole

    Measured: Approximately 2 years

  5. CBR

    To assess the clinical benefit rate for GB491 in Combination with Letrozole by investigator

    Measured: Approximately 2 years

  6. Plasma Concentration of GB491

    Plasma Concentration of GB491 Over Time

    Measured: At predefined intervals from Cycle 1, Day 1 & Day 15; Cycle 2, Day 1 (each cycle is 28 days)

  7. Plasma Concentration of Letrozole

    Plasma Concentration of Letrozole Over Time

    Measured: At predefined intervals from Cycle 1, Day 1 & Day 15; Cycle 2, Day 1 (each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2022
  2. Study start2 Jun 2021
  3. Primary completion12 Dec 2023 (estimated)
  4. Study completion1 Feb 2024 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05337657
Sponsor's protocol ID
GB491-005
Status last verified
Dec 2021
First submitted
21 Dec 2021
Last updated
20 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GB491+Letrozole in people with Advanced Breast Cancer, run by Genor Biopharma Co., Ltd. at 1 site in China.

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 11 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shawn Yu (021-60751991, shawn.yu@genorbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT (time frame: During Cycle 1 (up to 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05337657.

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 20 Apr 2022.

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