NCT06299124Active, not recruitingPhase 1
A Phase I Study of RGT-419B in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer or Other Solid Tumors
A Phase I Study Evaluating Safety and Tolerability of RGT-419B Monotherapy in Chinese Patients With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced/Metastatic Breast Cancer or Other Solid Tumors
Source: ClinicalTrials.gov · Last updated 27 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 1 Mar 2024
- Start date
- 17 Apr 2023
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Regor Pharmaceuticals Inc.
- Diseases
- Metastatic breast cancer
- NCT number
- NCT06299124
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 40
- From 17 Apr 2023 to the primary completion date, 30 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior irradiation to \>25% of the bone marrow and/or inadequate bone marrow function or evidence of clinicallysignificant end-organ damage
Other illness
- Known active hepatitis B or C infection
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the drugs usedin the study
Other
- Presence of visceral metastases with severe organ dysfunction
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.