Testing a new drug called PHST001 in adults with advanced solid tumors
Official title: A Study of PHST001 in Advanced Solid Tumors
Status: Recruiting. It is looking for patients now. Talk to your care team about whether it fits you.
The trial team last updated this record on .
The short version
This study is testing whether a new drug, PHST001, is safe for adults whose cancer has come back or kept growing.
Read our full plain-language summary
What the trial team says
This is a multi-center, first-in-human (FIH), open-label, Phase 1a/1b dose escalation and dose expansion study to assess the safety, PK, pharmacodynamics, and antitumor activity of PHST001 monotherapy (Phase 1a) or in combination with anticancer therapies (Phase 1b) in adult participants with advanced relapsed and/or refractory solid tumors (including but not limited to CNS tumors in Phase 1a only). Phase 1b will include the following cohorts 1) tumor-specific cohorts for participants with advanced relapsed and/or refractory ovarian cancer, endometrial cancer, and cholangiocarcinoma, 2) a randomized cohort for participants with ovarian cancer who will receive PHST001 in combination with mirvetuximab soravtansine, 3) a cohort for participants with advanced/metastatic breast cancer who will receive PHST001 in combination with trastuzumab deruxtecan and 4) a cohort of patients who consent to additional biomarker studies. The study's primary objectives are to evaluate the safety and tolerability of PHST001 and determine the RP2D (Recommended Phase 2 dose) of PHST001 as monotherapy and in combination with anticancer therapies, as well as to assess the anti-tumor activity of PHST001 in combination with anticancer therapies in Phase 1b.
Key facts
- Registry number
- NCT06840886
- Stage of testing
- Phase 1
- Conditions studied
- Advanced Solid Tumors, Ovarian Cancer, Endometrial Cancer, Cholangiocarcinoma, CNS Tumor, Breast Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Carcinosarcoma, Ovarian
Where it is running
This trial lists 20 sites.
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California
- Precision NextGen Oncology & Research Center (Beverly Hills)
- USC Norris Comprehensive Cancer Center (Los Angeles)
- Stanford University School of Medicine (Palo Alto)
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Colorado
- Sarah Cannon Research Institute (SCRI) Oncology Partners - Denver Health One (Denver)
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Connecticut
- Yale Cancer Center (New Haven)
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Illinois
- University of Chicago Medical Center (Chicago)
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Massachusetts
- Dana Farber Cancer Institute (Boston)
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Michigan
- University of Michigan Rogel Cancer Center (Ann Arbor)
- START Center for Cancer Research - Midwest (Grand Rapids)
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New York
- START Center for Cancer Research - Long Island New York (Lake Success)
- Mount Sinai (New York)
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North Carolina
- Duke Cancer Institute (Durham)
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Tennessee
- Sarah Cannon Research Institute (SCRI) Oncology Partners (Nashville)
- Vanderbilt-Ingram Cancer Center (Nashville)
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Texas
- START Center for Cancer Research - Texas (Fort Worth)
- MD Anderson Cancer Center (Houston)
- NEXT Oncology - Dallas (Irving)
- START Center for Cancer Research - San Antonio (San Antonio)
- University of Texas (UT) Health (San Antonio)
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Virginia
- NEXT Oncology - Virginia (Fairfax)
How to use this
Talk to your care team first. They know your history and can tell you whether this trial is worth your time.
Joining a trial is always your choice. A trial is a test, not a proven treatment. Being in one is not a promise that it will help you.
This page is built from the trial's listing on ClinicalTrials.gov, a service of the U.S. National Library of Medicine. That listing is the authority, and it may have changed since we last read it. We do not run this trial and we cannot enroll you in it.