RGT-490 for Breast Cancer

Recruiting at 2 trial locations

Overseen By Regor Pharmaceuticals Central Office

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Regor Pharmaceuticals Inc.

Must not be taking: Anti-hyperglycemics, PI3Kα inhibitors

Disqualifiers: Diabetes, CNS metastases, recent cancer therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

63 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

Inclusion Criteria

At least 1 measurable lesion or evaluable disease per RECIST v1.1

I am an adult with advanced cancer that has worsened after at least one treatment.

My cancer has a confirmed PIK3CA mutation.

Exclusion Criteria

I do not have any serious side effects from past cancer treatments that are still ongoing.

I have not had any cancer treatment or trial drugs recently.

I have not had another cancer in the past 2 years, except for those fully treated.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

RGT-490 is administered as monotherapy to determine the maximum tolerated dose

12 months

Every cycle (4-week cycles)

Dose Expansion

RGT-490 is administered as monotherapy to further evaluate safety and efficacy

12 months

Every cycle (4-week cycles)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RGT-490

How Is the Trial Designed?

Group I: Phase 1b Dose Expansion (HR+/HER2- locally advanced or metastatic breast cancer) Experimental Treatment 1 Intervention

RGT-490 given alone as monotherapy

Group II: Phase 1 Dose Escalation (Advanced Solid Tumors with PIK3CA mutation) Experimental Treatment 1 Intervention

RGT-490 given alone as monotherapy

Who Is Running the Clinical Trial?

Regor Pharmaceuticals Inc.

Lead Sponsor

Trials

6

Recruited

440+