Recruiting
Phase 1

RGT-490

Sponsor:

Regor Pharmaceuticals Inc.

Code:

NCT07524322

Conditions

Breast Cancer

Ovarian Cancer

Endometrial Cancer

PIK3CA Mutation

HER2- Negative Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RGT-490

Study Details

Brief 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.

Conditions

Breast Cancer

Ovarian Cancer

Endometrial Cancer

PIK3CA Mutation

HER2- Negative Breast Cancer

Study ID

NCT07524322

Start date

Jun, 2026

Status verified date

Jul, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

63 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1 Dose Escalation (Advanced Solid Tumors with PIK3CA mutation)

RGT-490 given alone as monotherapy

experimental: Phase 1b Dose Expansion (HR+/HER2- locally advanced or metastatic breast cancer)

RGT-490 given alone as monotherapy

Interventions

RGT-490

Oral tablets

Primary outcome measure

  • Incidence of dose limiting toxicities (DLTs) [ Time Frame: 4 weeks (1 cycle) ]
  • Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Every cycle (4-week cycles) until study discontinuation, approximately 12 months ]

Central Contacts and Locations

Central contacts

Sarah Wheeler

857-331-3898Sarah.Wheeler@regor.com

Regor Pharmaceuticals Central Office

617-315-9070RGT-490-101@regor.com

Locations

START Los Angeles

Recruiting

Los Angeles, California, United States, 90025

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

NEXT Houston

Recruiting

Houston, Texas, United States, 77054

NEXT San Antonio

Recruiting

San Antonio, Texas, United States, 78229

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Regor Pharmaceuticals Inc.

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Regor Pharmaceuticals Inc. on 2026-07-22.