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Trial Title: A Phase I Study of RGT-419B in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer or Other Solid Tumors

NCT ID: NCT06299124

Condition: Breast Cancer
Advanced Solid Tumor

Conditions: Official terms:
Breast Neoplasms

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: RGT-419B
Description: RGT-419B will be administered orally
Arm group label: RGT-419B monotherapy

Other name: Active drug

Summary: This is a Phase 1 dose escalation and dose expansion phase I study to evaluate the safety, tolerability, pharmacokinetic profile and preliminary efficacy of RGT-419B as monotherapy in Chinese patients with HR+/HER2- advanced/metastatic breast cancer and other advanced solid tumors.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Male or female ≥ 18 years of age - Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 - Subjects with pathologically confirmed advanced solid tumors who have failed standard-of-care therapy, or have no standard-of-care therapy available, or are currently not eligible for standard-of-care therapy; Subjects with HR+/ HER2- advanced or metastatic breast cancer are preferred. - Estimated life expectancy of at least 12 weeks Exclusion Criteria: - Presence of visceral metastases with severe organ dysfunction - Known active hepatitis B or C infection - Prior irradiation to >25% of the bone marrow and/or inadequate bone marrow function or evidence of clinicallysignificant end-organ damage - History of allergic reactions attributed to compounds of similar chemical or biologic composition to the drugs usedin the study

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Fudan University Shanghai Cancer Center

Address:
City: Shanghai
Zip: 200032
Country: China

Status: Recruiting

Contact:
Last name: Yan Zhou

Phone: 86-021-31168233

Start date: April 17, 2023

Completion date: June 30, 2025

Lead sponsor:
Agency: Regor Pharmaceuticals Inc.
Agency class: Industry

Source: Regor Pharmaceuticals Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06299124

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