PHST001 in adult patients with advanced relapsed and/or refractory solid tumors

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.

Who Can Participate?

Eligibility

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 Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

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.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

No

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
Mettu

Protocol Number

PRO00117506

NCT ID

NCT06840886

Phase

I

Enrollment Status

Pending Open to Enrollment
ClinicalTrials.gov