Testing PHST001 for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 2 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, low grade neoplasms, 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 from a systemic (non-CNS) primary malignancy. Participants with previously treated CNS metastases are eligible, provided they are radiologically and clinically stable (i.e., no evidence of progression for at least 2 weeks by repeat imaging performed during screening) and are not requiring systemic corticosteroids above the physiologic replacement for at least 7 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 it's running

• Precision NextGen Oncology & Research Center
  Beverly Hills, California, United States Recruiting
• USC Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• Stanford University School of Medicine
  Palo Alto, California, United States Recruiting
• Sarah Cannon Research Institute (SCRI) Oncology Partners - Denver Health One
  Denver, Colorado, United States Recruiting
• Yale Cancer Center
  New Haven, Connecticut, United States Recruiting
• University of Chicago Medical Center
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Raphaël Rousseau, Chief Medical Officer, PhD, MD
• Email: medical@pheast.com
• Phone: 650-260-8443

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.