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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Regor Pharmaceuticals Inc.
Study ID
NCT07524322
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
63 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Incidence of dose limiting toxicities (DLTs) [ Time Frame: 4 weeks (1 cycle) ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
START Los AngelesLos AngelesCalifornia90025-
NEXT HoustonHoustonTexas77054-
NEXT San AntonioSan AntonioTexas78229-
NEXT VirginiaFairfaxVirginia22031-

Find similar trials in Los Angeles, CA

By condition
Breast cancerCervical cancerEndometrial cancerOvarian cancer
By specialty
OncologyBreast oncologyWomen's healthGynecologic oncology
By research site
START Los Angeles· Los Angeles, CANEXT Houston· Houston, TXNEXT San Antonio· San Antonio, TXNEXT Virginia· Fairfax, VA

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