PHST001 in adult patients with advanced relapsed and/or refractory solid tumors - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if an experimental drug called PHTS001 (the study drug) is a safe and effective option for people who have advanced relapsed or refractory solid tumors.
What is the Condition Being Studied?
Advanced Relapsed and/or Refractory Solid Tumors
Who Can Participate in the Study?
Adults ages 18+ who:
- Are diagnosed with a histologically or cytologically confirmed advanced solid tumor which has
relapsed from or been refractory to all locally available standard therapies - Do not have any form of autoimmune disease that's required treatment in the past 2 years
- Are not diagnosed with HIV
For more information, contact the study team at hollie.watson@duke.edu.
Age Group
Adults
What is Involved?
There is no placebo used in this study, so everyone who takes part will get the study drug.
If you choose to join the study, you will:
- Get a dosing schedule to take the study drug
- Get a dose of the study drug once every 3 weeks by intravenous (IV) infusion
You will get up to 34 doses of the study drug during your time in the study.
We are testing 7 different dose levels of the study drug. The dose you are assigned will depend on when you join the study.
Study Details
Full Title
An open-label, Phase 1a/1b, dose escalation and dose expansion study investigating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of PHST001 in adult patients with advanced relapsed and/or refractory solid tumors
Principal Investigator
Niharika B. Mettu, MD, PhD
Medical Oncologist
Protocol Number
IRB:
PRO00117506
NCT:
NCT06840886
Phase
Phase
I
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment