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A Study of PHST001 in Advanced Solid Tumors

NCT06840886 · Pheast Therapeutics
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Official 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
About this study
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.
Eligibility criteria
Key Inclusion Criteria: * Histologically or cytologically confirmed advanced solid tumor which has relapsed from or been refractory to all locally available standard therapies. * Adequate organ function per laboratory testing * Pregnancy prevention requirements * Measurable disease per RECIST v1.1 (or RANO) as assessed by the local site Investigator/radiology * Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale Key Exclusion Criteria: * Diagnosis of immunodeficiency * History of a previous additional malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years. Participants with basal cell carcinoma of the skin, Stage I melanoma, melanoma in situ, squamous cell carcinoma of the skin, early-stage prostate cancer, or carcinoma in situ, excluding carcinoma in situ of the bladder, who have undergone potentially curative therapy are not excluded and can be enrolled regardless of disease-free period following completion of potentially curative therapy. Participants with early-stage breast cancer who have undergone curative intent treatment and with no disease recurrence for 2 years after treatment are not excluded. * Active known CNS metastases and/or carcinomatous meningitis. Participants with previously treated CNS metastases may participate provided they are radiologically stable (i.e., without evidence of progression for at least 2 weeks by repeat imaging \[note that the repeat imaging should be performed during study screening\]), clinically stable, and without requirement of steroid treatment for at least 14 days prior to the first dose of study treatment. * Received prior systemic anticancer therapy including investigational agents within 21 days or, if shorter, within 5 half-lives prior to the first dose of study treatment. Participants must have recovered from all AEs due to previous therapies to Grade ≤1 or baseline. Participants with Grade ≤2 neuropathy may be eligible. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible. * Prior autologous or allogeneic hematopoietic stem cell transplant or solid organ transplant. * Received previous treatment with another agent targeting CD24.
Study design
Enrollment target: 272 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-03-31
Estimated completion: 2031-04
Last updated: 2026-05-14
Interventions
Biological: PHST001Drug: Chemotherapy per Standard of Care
Primary outcomes
  • Frequency of Dose-Limiting Toxicities (DLTs) to assess the safety and tolerability of PHST001 as monotherapy (Phase 1a) or in combination with chemotherapy (Phase 1b) (From first dose of PHST001 through 21 days after the first dose of PHST001)
  • Frequency of Serious Adverse Events (SAEs) to assess the safety and tolerability of PHST001 as monotherapy (Phase 1a) or in combination with chemotherapy (Phase 1b) (From signed consent up to 90 days after the last dose of PHST001)
  • Frequency of Treatment Emergent Adverse Events (TEAEs) to assess the safety and tolerability of PHST001 as monotherapy (Phase 1a) or in combination with chemotherapy (Phase 1b) (From first dose up to 90 days after the last dose of PHST001)
Sponsor
Pheast Therapeutics · industry
Contacts & investigators
ContactAndrew Ferguson/VP Clinical Development, PhD · contact · medical@pheast.com · 434-249-2349
All locations (20)
Precision NextGen Oncology & Research CenterNot Yet Recruiting
Beverly Hills, California, United States
USC Norris Comprehensive Cancer CenterRecruiting
Los Angeles, California, United States
Stanford University School of MedicineRecruiting
Palo Alto, California, United States
Sarah Cannon Research Institute (SCRI) Oncology Partners - Denver Health OneRecruiting
Denver, Colorado, United States
Yale Cancer CenterRecruiting
New Haven, Connecticut, United States
University of Chicago Medical CenterRecruiting
Chicago, Illinois, United States
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
University of Michigan Rogel Cancer CenterRecruiting
Ann Arbor, Michigan, United States
START Center for Cancer Research - MidwestRecruiting
Grand Rapids, Michigan, United States
START Center for Cancer Research - Long Island New YorkRecruiting
Lake Success, New York, United States
Mount SinaiNot Yet Recruiting
New York, New York, United States
Duke Cancer InstituteRecruiting
Durham, North Carolina, United States
Sarah Cannon Research Institute (SCRI) Oncology PartnersRecruiting
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer CenterRecruiting
Nashville, Tennessee, United States
START Center for Cancer Research - TexasRecruiting
Fort Worth, Texas, United States
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
NEXT Oncology - DallasRecruiting
Irving, Texas, United States
South Texas Accelerated Research Therapeutics (START)Recruiting
San Antonio, Texas, United States
University of Texas (UT) HealthNot Yet Recruiting
San Antonio, Texas, United States
NEXT Oncology - VirginiaRecruiting
Fairfax, Virginia, United States
A Study of PHST001 in Advanced Solid Tumors · TrialPath