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New pill targets Hard-to-Treat cancers with PIK3CA mutation

NCT ID NCT07524322

Disease control Sponsor: Regor Pharmaceuticals Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 23, 2026 · Updated 4 times

Summary

This early-phase trial is testing an experimental oral drug called RGT-490 in about 63 adults with advanced solid tumors (including certain breast, ovarian, and endometrial cancers) that have a PIK3CA gene mutation and have stopped responding to standard treatments. The main goals are to check the drug's safety, find the right dose, and see if it can shrink 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-490 (oral tablet)
What this could lead to
If successful, this could point toward a new treatment option for people with certain hard-to-treat cancers that have a PIK3CA mutation.
What could go wrong
This is a very early (Phase 1) study with only 63 participants, so it is primarily testing safety and dosing. The drug may not shrink tumors or may cause side effects.

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

About 63 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm cervical cancer endometrial cancer endometrium neoplasm Her2-receptor negative breast cancer hormone receptor-positive breast cancer ovarian cancer Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced breast cancer Breast cancer Cervical cancer Endometrial cancer HER2-negative breast cancer Hormone receptor positive tumor Ovarian cancer PIK3CA mutation Unresectable solid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • NEXT Houston

    RECRUITING

    Houston, Texas, 77054, United States

  • NEXT San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • START Los Angeles

    RECRUITING

    Los Angeles, California, 90025, United States

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

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