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Recruiting NCT07524322

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

Phase I Interventional Breast Cancer Ovarian Cancer Endometrial Cancer PIK3CA Mutation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RGT-490.
Who it may be relevant to
Registry conditions: Breast Cancer, Ovarian Cancer, Endometrial Cancer, PIK3CA Mutation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug RGT-490
    Oral tablets

Primary outcome measures

  • 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]
Secondary outcome measures (9)
  • Characterize the Cmax (PK) of RGT-490 monotherapy in Dose Escalation [Time frame: First 3 treatment cycles (each cycle is 28 days)]
  • Characterize the Tmax (PK) of RGT-490 monotherapy in Dose Escalation [Time frame: First 3 treatment cycles (each cycle is 28 days)]
  • Characterize the AUC (PK) of RGT-490 monotherapy in Dose Escalation [Time frame: First 3 treatment cycles (each cycle is 28 days)]
  • Measure PD effects of RGT-490 monotherapy in Dose Escalation and Phase 1b [Time frame: First 7 cycles (each cycle is 28 days) and at study discontinuation]
  • Changes in fasting blood glucose [Time frame: Approximately every week in Cycle 1 and Cycle 2 (4-week cycle), every 2 weeks in Cycles 3-6 (4-week cycle), and every cycle through end of treatment (4-week cycles), approximately 24 months]
  • Changes in longitudinal glucose metabolism (All Phases) [Time frame: Approximately every cycle (4-week cycles) until study discontinuation, approximately 24 months]
  • Assess preliminary efficacy of RGT-490 monotherapy in dose escalation and Phase 1b [Time frame: Approximately every 8 weeks until progressive disease, approximately 12 months]
  • Evaluate additional measures of efficacy of RGT-490 [Time frame: Approximately every 8 weeks until progressive disease, approximately 36 months]
  • Evaluate additional measures of efficacy of RGT-490 [Time frame: Approximately every 8 weeks until progressive disease, approximately 36 months]

Eligibility 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 5 centers
  • START Los Angeles — Los Angeles
  • The University of Texas MD Anderson Cancer Center — Houston
  • NEXT Houston — Houston
  • NEXT San Antonio — San Antonio
  • NEXT Virginia — Fairfax

Identifiers

NCT: NCT07524322 · RGT-490-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗