Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Phase 1 Dose Escalation (Advanced Solid Tumors with PIK3CA mutation) |
RGT-490 given alone as monotherapy |
|
|
Experimental Phase 1b Dose Expansion (HR+/HER2- locally advanced or metastatic breast cancer) |
RGT-490 given alone as monotherapy |
|
Recruiting Locations
START Los Angeles
Los Angeles, California 90025
Los Angeles, California 90025
NEXT Houston
Houston, Texas 77054
Houston, Texas 77054
NEXT San Antonio
San Antonio, Texas 78229
San Antonio, Texas 78229
NEXT Virginia
Fairfax, Virginia 22031
Fairfax, Virginia 22031
More Details
- Status
- Recruiting
- Sponsor
- Regor Pharmaceuticals Inc.