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

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.

Trial Details

NCT ID
NCT07524322
Phase
PHASE1
Sponsor
Regor Pharmaceuticals Inc.
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • RGT-490
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Houston, Texas, United States|29.76328,-95.36327
  • San Antonio, Texas, United States|29.42412,-98.49363
  • Fairfax, Virginia, United States|38.84622,-77.30637

Key Eligibility 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.

For full eligibility, visit ClinicalTrials.gov.

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