Actively Recruiting
A Study of PHST001 in Advanced Solid Tumors
Led by Pheast Therapeutics · Updated on 2026-05-14
272
Participants Needed
20
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 chemotherapy (Phase 1b) in adult participants with advanced relapsed and/or refractory solid tumors (including but not limited to CNS tumors in Phase 1a only). In Phase 1b cohort expansions, the study will focus on participants with advanced relapsed and/or refractory ovarian cancer, endometrial cancer, and cholangiocarcinoma. The study's primary objective is to evaluate the safety and tolerability of PHST001 and determine the RP2D (Recommended Phase 2 dose) of PHST001 monotherapy and in combination with chemotherapy as well as assess the anti-tumor activity of PHST001 and chemotherapy in Phase 1b.
CONDITIONS
Official Title
A Study of PHST001 in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with histologically or cytologically confirmed advanced solid tumors that have relapsed or are refractory to all locally available standard therapies
- Adequate organ function confirmed by laboratory tests
- Use of effective pregnancy prevention methods
- Measurable disease according to RECIST v1.1 or RANO criteria as assessed by local investigator or radiologist
- Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
You will not qualify if you...
- Diagnosis of immunodeficiency
- History of another malignancy unless treated with curative intent and no evidence of disease for at least 5 years, except certain skin cancers, early prostate cancer, or carcinoma in situ (excluding bladder) after curative treatment
- Active central nervous system metastases or carcinomatous meningitis; stable treated CNS metastases allowed if no progression for at least 2 weeks, clinically stable, and no steroid treatment for at least 14 days before first dose
- Received systemic anticancer therapy including investigational agents within 21 days or 5 half-lives before first dose; must have recovered from related adverse events to Grade 61 or baseline
- Prior autologous or allogeneic hematopoietic stem cell or solid organ transplant
- Prior treatment with agents targeting CD24
AI-Screening
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Trial Site Locations
Total: 20 locations
1
Precision NextGen Oncology & Research Center
Beverly Hills, California, United States, 90212
Not Yet Recruiting
2
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
3
Stanford University School of Medicine
Palo Alto, California, United States, 94304
Actively Recruiting
4
Sarah Cannon Research Institute (SCRI) Oncology Partners - Denver Health One
Denver, Colorado, United States, 80218
Actively Recruiting
5
Yale Cancer Center
New Haven, Connecticut, United States, 06520
Actively Recruiting
6
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
7
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
8
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
9
START Center for Cancer Research - Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
10
START Center for Cancer Research - Long Island New York
Lake Success, New York, United States, 11042
Actively Recruiting
11
Mount Sinai
New York, New York, United States, 10029
Not Yet Recruiting
12
Duke Cancer Institute
Durham, North Carolina, United States, 27710
Actively Recruiting
13
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
14
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37203
Actively Recruiting
15
START Center for Cancer Research - Texas
Fort Worth, Texas, United States, 76104
Actively Recruiting
16
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
17
NEXT Oncology - Dallas
Irving, Texas, United States, 75039
Actively Recruiting
18
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States, 78229
Actively Recruiting
19
University of Texas (UT) Health
San Antonio, Texas, United States, 78229
Not Yet Recruiting
20
NEXT Oncology - Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
A
Andrew Ferguson/VP Clinical Development, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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