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Advanced Breast CancerPhase 1NCT04856371

Study of CYH33 in Combination With Endocrine Therapy With or Without Palbociclib in Patients With HR+, HER2- Advanced Breast Cancer

A Phase 1 study testing CYH33, Fulvestrant and Letrozole in people with Advanced Breast Cancer, run by Haihe Biopharma Co., Ltd..

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a multicenter, open-label, phase Ib study designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of CYH33 administered orally in combination with standard-of-care ET ± CDK4/6 inhibitor therapies for the treatment of locally advanced, recurrent or metastatic hormone-receptor… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Breast Cancer
What is being tested?
CYH33, Fulvestrant and Letrozole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
228 participants
Where
No sites listed yet
Study dates
Apr 2021to Dec 2022
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Main Inclusion Criteria:

  1. Provide informed consent voluntarily.
  2. Male and female patients ≥ 18 years of age.
  3. Patient must have a histologically or cytologically documented locally advanced, recurrent or metastatic breast cancer.
  4. In case of women, both premenopausal and postmenopausal patients can be enrolled in the study.
  5. Confirmed diagnosis of HR+, HER2- breast cancer.
  6. For Stage 1 dose exploration phase, patients with or without PIK3CA mutation may be enrolled; For Stage 2 dose expansion phase, patients with PIK3CA mutations are required.
  7. Patient must have evidence of disease radiological progression after previous endocrine therapy, or other systemic therapy.
  8. Patient has measurable disease per RECIST v1.1.
  9. ECOG ≤ 1.
  10. Patient must have adequate organ and bone marrow function.

Main Exclusion Criteria:

  1. Previously received any anticancer therapy within 28 days or 5 times of half-lives prior to the first dose of the study treatment.
  2. Previously received treatment with any PI3Kα inhibitor, AKT inhibitor, or mTOR inhibitor.
  3. Radical radiation therapy within 4 weeks prior to the first dose of the study treatment.
  4. Patient with an established diagnosis of diabetes mellitus.
  5. Any other concurrent disease with potential risk of insulin resistance or current use of medication with potential risk of insulin resistance.
  6. Patient with clinically significant cardiovascular disease.

Trial locations and contacts

No sites are listed yet.

Yong Yuan, MD contact

86 13820384005

yong.yuan@haihepharma.com

About this study

Official title: A Multicenter, Open-label, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CYH33 in Combination With Endocrine Therapy With or Without Palbociclib in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer

This is a multicenter, open-label, phase Ib study designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of CYH33 administered orally in combination with standard-of-care ET ± CDK4/6 inhibitor therapies for the treatment of locally advanced, recurrent or metastatic hormone-receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer. Patients will be enrolled in two stages, including dose exploration phase (Stage 1) and dose expansion phase (Stage 2) of each cohort.

Being tested
CYH33, Fulvestrant, Letrozole, Palbociclib
Keywords
PIK3CA Mutant, Advanced Breast Cancer

What participants receive

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

  • CYH33Drug

    Participants will receive oral CYH33 once daily on Days 1-28 of each 28-day cycle.

  • FulvestrantDrug

    Participants will receive fulvestrant 500 mg, administered intramuscularly on Days 1, 15 on Cycle 1 (28-day cycle) and Day 1 at each 28-day cycle thereafter.

  • LetrozoleDrug

    Participants will receive oral letrozole once daily continuous on Day 1-28 of each cycle.

  • PalbociclibDrug

    Participants will receive palbociclib once daily continuous on Day 1-21 of each 28-day cycle.

Study groups in NCT04856371
Study groupRoleWhat they receive
CYH33 + fulvestrantExperimentalParticipants will receive CYH33 in combination with a standard fixed dose of fulvestrant 500 mg.
Receives: Drug: CYH33; Drug: Fulvestrant
CYH33 + fulvestrant + palbociclibExperimentalParticipants will receive CYH33 in combination with standard fixed dose of fulvestrant (500 mg) and palbociclib (125 mg).
Receives: Drug: CYH33; Drug: Fulvestrant; Drug: Palbociclib
CYH33 + letrozole + palbociclibExperimentalParticipants will receive CYH33 in combination with standard fixed dose of letrozole (2.5 mg) and palbociclib (125 mg)
Receives: Drug: CYH33; Drug: Letrozole; Drug: Palbociclib

What is being measured

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

  1. Dose Limiting Toxicities (DLT)

    Incidence rate of DLT in the first cycle (of 28 days).

    Measured: 28 days

Secondary outcomes (15)

  1. Safety and tolerability

    Type, incidence, duration, severity and seriousness of adverse events (AEs).

    Measured: 30 months

  2. Preliminary efficacy-ORR

    Tumor objective response rate (ORR) assessed by RECIST v1.1

    Measured: 30 months

  3. Preliminary efficacy-CBR

    Clinical benefit rate (CBR) assessed by RECIST v1.1

    Measured: 30 months

  4. Preliminary efficacy-PFS

    Progression Free Survival (PFS) assessed by RECIST v1.1

    Measured: 30 months

  5. Pharmacokinetic measures - AUC

    Measure the variation of concentration in blood plasma as a function of time

    Measured: 20 months

  6. Pharmacokinetic measures - C trough

    Measure the minimum (trough) plasma concentration

    Measured: 20 months

  7. Pharmacokinetic measures - Cmax

    Measure the maximum (peak) plasma concentration

    Measured: 20 months

  8. Pharmacokinetic measures - Tmax

    Measure of time to reach maximum (peak) plasma concentration

    Measured: 20 months

  9. Pharmacokinetic measures - CL/F

    Measure apparent total clearance(s) from plasma after administration

    Measured: 20 months

  10. Pharmacokinetic measures - Vz/F

    Measure apparent volume of distribution during terminal phase

    Measured: 20 months

  11. Assess downstream effects of PI3K pathway inhibition on blood glucose

    Pre- and post-treatment of blood glucose

    Measured: 20 months

  12. Assess downstream effects of PI3K pathway inhibition on C peptide

    Pre- and post-treatment of C peptide

    Measured: 20 months

  13. Assess the changes of biomarker-PIK3CA

    Pre- and post-treatment PIK3CA changes in ctDNA samples.

    Measured: 20 months

  14. Assess the changes of biomarker-PTEN

    Pre- and post-treatment PTEN changes in ctDNA samples.

    Measured: 20 months

  15. Assess the changes of biomarker-KRAS

    Pre- and post-treatment KRAS changes in ctDNA samples.

    Measured: 20 months

Timeline

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

  1. First posted23 Apr 2021
  2. Study startApr 2021 (estimated)
  3. Primary completionMar 2022 (estimated)
  4. Study completionDec 2022 (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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
228 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04856371
Sponsor's protocol ID
CYH33-G103
Status last verified
Mar 2021
First submitted
11 Apr 2021
Last updated
23 Apr 2021
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 CYH33, Fulvestrant and Letrozole in people with Advanced Breast Cancer, run by Haihe Biopharma Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

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 Yong Yuan, MD (86 13820384005, yong.yuan@haihepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicities (DLT) (time frame: 28 days). 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 NCT04856371.

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 23 Apr 2021.

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