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Clinical trial Recruiting at 6 sites Phase 1 Interventional Ages 18 and up

RGT-490 for adults with PIK3CA-mutated advanced solid tumors

Official title: A Phase 1/1b Open-Label, Multicenter, First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of RGT-490 as a Single Agent in Adult Subjects With Locally Advanced or Metastatic PIK3CA-Mutated Solid Tumors Including HR+/HER2- Breast Cancers

Run by Regor Pharmaceuticals Inc. · NCT07524322 · Data updated 2026-11-12

This trial will test RGT-490, an oral medicine, in adults whose advanced solid tumors carry a PIK3CA mutation and have progressed after prior therapy.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment63 (estimated)
SponsorRegor Pharmaceuticals Inc.
Industry-sponsored
Locations6 sites (Los Angeles, California and 5 other locations)
StatusRecruiting
StartedJuly 21, 2026
Main results expectedApril 2028
Study endsOctober 2028
Registry record updatedNovember 2, 2026
Trial IDNCT07524322 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with unresectable or metastatic solid tumors that harbor a documented activating PIK3CA mutation, have progressed after at least one prior therapy, have measurable or evaluable disease, ECOG 0–1, and adequate organ function are ideal candidates.

Probably not a fit

Patients without a PIK3CA mutation, those who received prior PI3Kα inhibitors, those with diabetes requiring anti-hyperglycemic drugs, or those with uncontrolled symptomatic CNS metastases are unlikely to benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1/1b, open-label, multicenter study uses sequential parts (dose-escalation followed by expansion cohorts) to characterize the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of oral RGT-490 in adults with locally advanced or metastatic solid tumors that harbor activating PIK3CA alterations. Eligible participants have measurable or evaluable disease per RECIST v1.1, an ECOG performance status of 0–1, and adequate organ function, and must have progressed on or after at least one available therapy. Key exclusions include prior PI3Kα inhibitor therapy, diabetes requiring anti-hyperglycemic medication, and uncontrolled or symptomatic CNS metastases. Sites for enrollment are in Houston and San Antonio, Texas, and Fairfax, Virginia, with dosing and safety/efficacy assessments conducted according to protocol schedules.

Why it matters

Potential benefit: If successful, RGT-490 could shrink tumors or slow disease progression in patients whose cancers are driven by PIK3CA mutations.

How similar studies have gone: Similar targeted approaches have precedent—PI3Kα inhibitors such as alpelisib have shown benefit in PIK3CA-mutant breast cancer—so the mechanism has demonstrated activity though toxicity and resistance remain concerns.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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).

Where it's running

  • START Los Angeles
    Los Angeles, California, United States     Recruiting
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania, United States     Recruiting
  • The University of Texas MD Anderson Cancer Center
    Houston, Texas, United States     Recruiting
  • NEXT Houston
    Houston, Texas, United States     Recruiting
  • NEXT San Antonio
    San Antonio, Texas, United States     Recruiting
  • NEXT Virginia
    Fairfax, Virginia, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.