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

NCT ID NCT07524322

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

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.

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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

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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