Breast CancerOvarian CancerEndometrial CancerPIK3CA MutationHER2- Negative Breast CancerAdvanced Breast CancerUnresectable Solid TumorHormone Receptor Positive TumorCervical Cancer
Investigational drug(s) / intervention(s)
RGT-490
RGT-490: Oral tablets
Study summary
This is a phase 1/1b, open-label, multicenter study consisting of sequential parts designed to evaluate the safety, tolerability, and effects pharmacokinetic (PK) profile, and antitumor activity of RGT-490, an investigational oral therapy, in adults with locally advanced or metastatic solid tumors including breast cancer.
Participants enrolled in the study have advanced disease that is not amendable to curative treatment and whose tumors harbor alterations in the PI3KCA gene.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Adults with metastatic or locally advanced, unresectable solid tumors that have progressed on or after at least one available therapy.
* Presence of one or more documented activating PIK3CA mutation in tumor tissue and/or blood.
* At least 1 measurable lesion or evaluable disease per RECIST v1.1.
* An ECOG performance status of 0 or 1.
* Adequate organ function
Exclusion Criteria:
* Diabetes mellitus requiring anti-hyperglycemic medication.
* Prior treatment with PI3Kα inhibitors
* Symptomatic, untreated, or uncontrolled central nervous system metastases.
* Receipt of any local or systemic anticancer therapy or investigational anticancer agent within a protocol-defined washout period prior to study treatment.
* Unresolved clinically significant toxicities from prior anticancer therapy
* History of a another malignancy within 2 years prior to screening (exception adequately treated cancers).
Primary outcome measure(s)
Incidence of dose limiting toxicities (DLTs) — 4 weeks (1 cycle) Number of subjects who experience at least 1 Dose Limiting Toxicity (DLT)
Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) — Every cycle (4-week cycles) until study discontinuation, approximately 12 months Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) and AEs leading to dose modifications and dose limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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