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NCT07524322 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Regor Pharmaceuticals.

Recruiting
Registry status
Phase 1
Development phase
63
Enrollment target

NCT07524322: Recruiting Phase 1 study, sponsored by Regor Pharmaceuticals.

NCT07524322 is a Phase 1 study that is actively recruiting participants, run by Regor Pharmaceuticals. The registered enrollment target is 63 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT07524322, a Phase 1 study, is actively recruiting participants, sponsored by Regor Pharmaceuticals.

RECRUITING
Registry status
Phase 1
Development phase
63 participants
Enrollment target

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.

Primary Outcome

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

Interventions

  • DRUG RGT-490

Trial Details

FieldValue
Enrollment Target 63 participants
Start Date 2026-06
Est. Completion 2028-10
Phase Phase 1
Regor Pharmaceuticals

5 total trials

What NCT07524322 shows while recruiting

NCT07524322 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 1 intervention - of which RGT-490 is the first listed.

NCT07524322 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07524322 about?

NCT07524322 is a clinical study titled "Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors". 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 i...

What is the current status of trial NCT07524322?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 63 participants. The study started on 2026-06. Estimated completion is 2028-10.

What interventions are being tested in trial NCT07524322?

The interventions under investigation include: RGT-490 (DRUG).

Who is sponsoring clinical trial NCT07524322?

This trial is sponsored by Regor Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07524322's enrollment target sits among peer trials

63 820th of 2000 higher than 1,177 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07524322, the US trial registry maintained by the National Library of Medicine. NCT07524322 (small enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.