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

Study Identifier:
RGT-490-101
CT.gov Identifier:
NCT07524322
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Recruiting

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Study 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Breast Cancers
Ovarian
Endometrial
Gene Mutations
Unmapped
Solid Tumor
Unmapped
Cervical cancer
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
N/A
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Phase 1b Dose Expansion (HR+/HER2- locally advanced or metastatic breast cancer)
Read More
Drug: RGT-490 given alone as monotherapy
Drug: Drug: RGT-490
Drug: Oral tablets
Drug: EXPERIMENTAL: Phase 1 Dose Escalation (Advanced Solid Tumors with PIK3CA mutation)
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
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).

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Los Angeles
Los Angeles, CA, United States, 90025
Investigator
Navid Hafez
Status
Recruiting
Condition(s) Treated at Site
Breast Cancers
Ovarian
Endometrial
Gene Mutations
Unmapped
Solid Tumor
Unmapped
Cervical cancer