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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