Can a new oral drug tame advanced breast cancer?
NCT ID NCT06299124
First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This early-stage trial tests an oral drug called RGT-419B in Chinese patients with advanced or metastatic breast cancer that is hormone receptor positive and HER2 negative, as well as other advanced solid tumors. The main goal is to see if the drug is safe and tolerable, and to find the right dose. Researchers will also look at how the drug moves through the body and whether it shows any signs of shrinking tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RGT-419B, an oral drug being tested as a single treatment
- What this could lead to
- If it works, this could point toward a new treatment option for advanced breast cancer and other solid tumors that have stopped responding to standard care.
- What could go wrong
- This is an early phase 1 trial with only 40 participants, so the drug may not be safe or effective. Side effects are possible, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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