Trials / Not Yet Recruiting
Not Yet RecruitingNCT07524322
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
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 63 (estimated)
- Sponsor
- Regor Pharmaceuticals Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RGT-490 | Oral tablets |
Timeline
- Start date
- 2026-04-01
- Primary completion
- 2028-04-01
- Completion
- 2028-10-01
- First posted
- 2026-04-13
- Last updated
- 2026-04-13
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07524322. Inclusion in this directory is not an endorsement.