The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary how well it works of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants with HR+/HER2- advanced/metastatic breast cancer.
Official registry: https://clinicaltrials.gov/study/NCT07558733 · Faeth Therapeutics · enrollment listed as 32
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are Serabelisib, Sapanisertib, or Fulvestrant. The registry lists allocation as randomized. The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary how well it works of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants with HR+/HER2- advanced/metastatic breast cancer.
They plan to enroll about 32 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Open-Label Umbrella Study to Evaluate Safety and Efficacy of Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced or Metastatic Breast Cancer
Interventions: Serabelisib, Sapanisertib, Fulvestrant
Primary outcome (registry wording): Safety and tolerability of drugs by assessment of adverse events (AEs) / serious adverse events (SAEs)
Medical Monitor
clinicaltrials@faeththerapeutics.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
This study will collect blood from patients with cancer to study the level of cells which decrease the immune response (suppressor cells) before and after chemotherapy. Patients 18 years of age and older with cancer may participate.
NCT00034216 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)
This study aims to provide long-term follow-up care of patients previously enrolled in a vaccine study that involved poxviral vectors. Vectors are sequences of genetic material that can be used to introduce specific genes into genetic makeup.
NCT00451022 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)
Background: The NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 200 patients with melanoma.
NCT01174121 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary