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Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer

NCT07558733 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-07-02

No results posted yet for this study

Summary

The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants with HR+/HER2- advanced/metastatic breast cancer.

Conditions

  • HR+ HER2- Breast Cancer

Interventions

DRUG

Serabelisib

Serabelisib is a selective, small molecule inhibitor of PI3Kα.

DRUG

Sapanisertib

Sapanisertib is a small molecule inhibitor of the mammalian mTOR serine/threonine kinase.

DRUG

Fulvestrant

Fulvestrant is a first-in-class SERD.

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-22
Primary Completion
2029-05-31
Completion
2033-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07558733 on ClinicalTrials.gov