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

NCT05337657 | Unknown Phase 1

• 1 other identifier: GB491-005
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (2)

• DLT

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

  During Cycle 1 (up to 28 days)

• 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)

  From Baseline until 30 days after the last treatment

Secondary Outcomes (7)

• PFS

  Approximately 2 years

• ORR

  Approximately 2 years

• DOR

  Approximately 2 years

• DCR

  Approximately 2 years

• CBR

  Approximately 2 years

Study Arms (1)

GB491+Letrozole

EXPERIMENTAL

Drug: GB491+Letrozole

Interventions

GB491+Letrozole DRUG

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

GB491+Letrozole

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Genor Biopharma Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Study Officials

• Xichun Hu, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

• Jian Zhang, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shawn Yu

CONTACT

021-60751991; shawn.yu@genorbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: April 20, 2022
• Study Start: June 2, 2021
• Primary Completion: December 12, 2023
• Study Completion: February 1, 2024
• Last Updated: April 20, 2022

Record last verified: 2021-12

Locations

CN (1)