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Testing PHST001 for advanced solid tumors

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

Phase 1 Interventional Pheast Therapeutics · NCT06840886

This study is testing a new treatment called PHST001 to see if it is safe and effective for people with advanced solid tumors that haven't responded to other therapies.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment272 (estimated)
Ages18 Years and up
SexAll
SponsorPheast Therapeutics Industry-sponsored
Drugs / interventionschemotherapy
Locations20 sites (Beverly Hills, California and 19 other locations)
Trial IDNCT06840886 on ClinicalTrials.gov

What this trial studies

This is a multicenter, open-label Phase 1 study evaluating the safety and tolerability of PHST001 in patients with advanced solid tumors that have relapsed or are refractory to standard therapies. The study consists of a Dose Escalation Phase to determine the Recommended Phase 2 dose (RP2D) of PHST001, followed by a Dose Expansion Phase. Patients will be closely monitored for adverse effects and treatment responses throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are patients with histologically or cytologically confirmed advanced solid tumors that have relapsed or are refractory to all locally available standard therapies.

Not a fit: Patients with a history of additional malignancies or those who have not met the specified eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that have not responded to existing therapies.

How similar studies have performed: Other studies have shown promise with similar approaches in treating advanced solid tumors, but the specific compound PHST001 is novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Beverly Hills, California and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Solid TumorsOvarian CancerEndometrial CancerCholangiocarcinomaCNS Tumor
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.