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Study of RGT-490 for PIK3CA-Mutated Advanced Solid Tumors

This study is testing an investigational oral medication called RGT-490 for adults with advanced solid tumors, including breast, ovarian, and endometrial cancers. These cancers must have a specific change in a gene called PIK3CA. You might be able to join if your cancer has grown despite at least one previous treatment and you have a good general health status. The main goals are to understand the safety of RGT-490, including any side effects, and how your body handles the drug. Researchers will also look for signs that the drug is helping to shrink the tumor. This study is currently enrolling about 63 participants.

Study design
This is an early-phase (Phase 1/1b), open-label study, meaning both you and your doctors will know you are receiving RGT-490. It is designed to evaluate the drug in approximately 63 participants.
What's involved
You would take RGT-490 as oral tablets. Safety will be checked every 4-week cycle until you stop the study, for approximately 12 months.
Compensation
Not stated in the trial record.
Follow-up
Safety will be monitored every 4-week cycle until study discontinuation, for approximately 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07524322

Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Regor Pharmaceuticals Inc.
~63 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:RGT-490

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of dose limiting toxicities (DLTs)
Measured over 4 weeks (1 cycle)
+1 more outcome measured

Conditions

Breast Cancer
Ovarian Cancer
Endometrial Cancer
PIK3CA Mutation
HER2- Negative Breast Cancer
Advanced Breast Cancer
Unresectable Solid Tumor
Hormone Receptor Positive Tumor
Cervical Cancer

Explore related trials

Breast CarcinomaCervical CarcinomaEndometrial CarcinomaMalignant Ovarian NeoplasmSolid NeoplasmPIK3CA Gene

Where it's being run

5 sites across 3 states
Texas3
California1
Virginia1

Who to contact

Sarah Wheeler
[email protected]
857-331-3898
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • 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)