What this study is
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.
What's being tested
- RGT-490
Intervention · DRUG
Oral tablets
Study details
- 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
- Sponsor
- Regor Pharmaceuticals Inc.
- Conditions
- Breast Cancer · Ovarian Cancer · Endometrial Cancer · PIK3CA Mutation · HER2- Negative Breast Cancer · Advanced Breast Cancer · Unresectable Solid Tumor · Hormone Receptor Positive Tumor · Cervical Cancer
- Enrolling
- 63 people
- Starts
- 2026-07-21
- Est. completion
- 2028-10
- Design
- Open-label, non-randomized, sequential groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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).
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (6)
6 openSTART Los Angeles
Los Angeles, California, United States
RecruitingUniversity of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
RecruitingThe University of Texas MD Anderson Cancer Center
Houston, Texas, United States
RecruitingNEXT Houston
Houston, Texas, United States
RecruitingNEXT San Antonio
San Antonio, Texas, United States
RecruitingNEXT Virginia
Fairfax, Virginia, United States
Recruiting
Study team
Sponsor
Regor Pharmaceuticals Inc.
Study ID RGT-490-101
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.