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RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests RGT-490, an experimental medicine taken by mouth, in adults with advanced solid tumors, including breast cancer. It is for people whose cancer has a PIK3CA gene change and cannot be cured with treatment. Researchers will study its safety, how the body handles it, and its effects on cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are an adult with a solid tumor that has spread or grown nearby and cannot be removed by surgery.
  • Your cancer got worse during or after at least one available treatment.
  • Tests of your tumor or blood show a PIK3CA gene change that makes it more active.
  • Your cancer can be measured or checked using the study’s rules.
  • You can do all usual activities, or can do light work but have trouble with hard physical activity.
  • Your organs work well enough to meet the study’s rules.

Who can't join

  • You have diabetes that needs medicine to lower blood sugar.
  • You previously received a PI3Kα inhibitor, a medicine that blocks a specific form of the PI3K protein.
  • Your cancer has spread to the brain or spinal cord and causes symptoms, has not been treated, or is not controlled.
  • You received cancer treatment, including an experimental cancer medicine, too recently before starting study treatment. The study sets the required waiting time.
  • You still have significant side effects from earlier cancer treatment.
  • You had another cancer within 2 years before screening, unless it was treated well enough to qualify for an exception.

Simplified for readability. The official criteria below are what the study team uses.

Official 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).

Study sites (5)

CA

TX

VA