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

NCT ID: NCT04856371

Last Updated: 2021-04-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2022-12-31

Brief 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 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.

Conditions

Advanced Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CYH33 + fulvestrant

Participants will receive CYH33 in combination with a standard fixed dose of fulvestrant 500 mg.

Group Type: EXPERIMENTAL

CYH33

Intervention Type: DRUG

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

Fulvestrant

Intervention Type: DRUG

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.

CYH33 + fulvestrant + palbociclib

Participants will receive CYH33 in combination with standard fixed dose of fulvestrant (500 mg) and palbociclib (125 mg).

Group Type: EXPERIMENTAL

CYH33

Intervention Type: DRUG

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

Fulvestrant

Intervention Type: DRUG

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.

Palbociclib

Intervention Type: DRUG

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

CYH33 + letrozole + palbociclib

Participants will receive CYH33 in combination with standard fixed dose of letrozole (2.5 mg) and palbociclib (125 mg)

Group Type: EXPERIMENTAL

CYH33

Intervention Type: DRUG

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

Letrozole

Intervention Type: DRUG

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

Palbociclib

Intervention Type: DRUG

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

Interventions

CYH33

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

Intervention Type: DRUG

Fulvestrant

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.

Intervention Type: DRUG

Letrozole

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

Intervention Type: DRUG

Palbociclib

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

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haihe Biopharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Yong Yuan, MD

Role: CONTACT

yong.yuan@haihepharma.com

86 13820384005

Other Identifiers

CYH33-G103

Identifier Type: -

Identifier Source: org_study_id