Health TrialsbyHealthPanel

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

ConditionsBreast CancerOvarian CancerEndometrial CancerPIK3CA MutationHER2- Negative Breast CancerAdvanced Breast CancerUnresectable Solid TumorHormone Receptor Positive TumorCervical Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegor Pharmaceuticals Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • RGT-490

    Drug

    Oral tablets

Treatment groups

63 Participants
are divided into 2 treatment groups
Group A: Phase 1 Dose Escalation (Advanced Solid Tumors with PIK3CA mutation)Experimental treatment 1 intervention
Group B: Phase 1b Dose Expansion (HR+/HER2- locally advanced or metastatic breast cancer)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of dose limiting toxicities (DLTs)

Number of subjects who experience at least 1 Dose Limiting Toxicity (DLT)

Time frame
4 weeks (1 cycle)
2

Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) and AEs leading to dose modifications and dose limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD)

Time frame
Every cycle (4-week cycles) until study discontinuation, approximately 12 months

Secondary outcomes

1

Characterize the Cmax (PK) of RGT-490 monotherapy in Dose Escalation

Maximum observed plasma concentration (Cmax) of RGT-490

Time frame
First 3 treatment cycles (each cycle is 28 days)
2

Characterize the Tmax (PK) of RGT-490 monotherapy in Dose Escalation

Maximum observed plasma concentration (Tmax) of RGT-490

Time frame
First 3 treatment cycles (each cycle is 28 days)
3

Characterize the AUC (PK) of RGT-490 monotherapy in Dose Escalation

Calculated area under the plasma concentration curve (AUC) of RGT-490

Time frame
First 3 treatment cycles (each cycle is 28 days)
4

Measure PD effects of RGT-490 monotherapy in Dose Escalation and Phase 1b

Change from baseline in ctDNA levels; Change from baseline in PD markers in paired biopsies

Time frame
First 7 cycles (each cycle is 28 days) and at study discontinuation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Regor Pharmaceuticals Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now