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A Study of PHST001 in Advanced Solid Tumors

This study is testing a new treatment called PHST001 for people with advanced solid tumors, including ovarian, endometrial, cholangiocarcinoma, and CNS (brain or spinal cord) tumors. PHST001 is a biological drug given through IV (intravenous) infusions every three weeks. It works by targeting a protein called CD24 on certain cells. The study will first look at PHST001 by itself, and then combine it with standard chemotherapy. The main goal is to understand how safe PHST001 is and what side effects it might cause. You may be able to join if you are 18 or older, have an advanced solid tumor that has not responded to other treatments, and meet other health requirements. The current recruitment status is unclear.

Study design
This is an open-label, multi-center Phase 1a/1b study, meaning both you and your doctors will know which treatment you are receiving. It plans to enroll 272 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to 90 days after your last dose of PHST001.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06840886

A Study of PHST001 in Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Pheast Therapeutics
~272 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:PHST001Chemotherapy per Standard of Care

At a glance

Recruiting sites
20 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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)
Measured over From first dose of PHST001 through 21 days after the first dose of PHST001
+10 more outcomes measured

Conditions

Advanced Solid Tumors
Ovarian Cancer
Endometrial Cancer
Cholangiocarcinoma
CNS Tumor

Explore related trials

Central Nervous System NeoplasmCholangiocarcinomaEndometrial CarcinomaMalignant Ovarian NeoplasmSolid Neoplasm

Where it's being run

20 sites across 11 states
Texas5
California3
Michigan2
New York2
Tennessee2
Colorado1
Connecticut1
Illinois1

Who to contact

Andrew Ferguson/VP Clinical Development, PhD
[email protected]
434-249-2349
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

  • 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

    Based on toxicities observed

  • 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

    Based on toxicities observed

  • 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

    Based on toxicities observed

  • Frequency of Treatment Related Adverse Events (TRAEs) 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

    Based on toxicities observed

  • Frequency of Adverse Events of Special Interest (AESIs) 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

    Based on toxicities observed

  • Frequency of AEs Leading to Dose Interruption or Treatment Discontinuation and AEs Leading to Death 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

    Based on toxicities observed

  • Overall Response Rate (ORR) based on RECIST v1.1 to assess the preliminary antitumor activity of PHST001 in combination with chemotherapy (Phase 1b)From screening and during treatment up to 2 years

    Defined as the proportion of subjects with confirmed complete response (CR) or partial response (PR); a confirmed response is a response that persists on repeat-imaging ≥ 4 weeks after initial documentation of response.

  • Duration of Response (DOR) based on RECIST v1.1 to assess the preliminary antitumor activity of PHST001 in combination with chemotherapy (Phase 1b)From screening and during treatment up to 2 years

    Defined as time from date of first objective response (either CR or PR) to first documentation of radiographic disease progression.

  • Best Overall Response (BOR) based on RECIST v1.1 to assess the preliminary antitumor activity of PHST001 in combination with chemotherapy (Phase 1b)From screening and during treatment up to 2 years

    Defined as the best response recorded for a participant across all time-point assessments from the start of treatment until disease progression or end of treatment.

  • Progression-Free Survival (PFS) based on RECIST v1.1 to assess the preliminary antitumor activity of PHST001 in combination with chemotherapy (Phase 1b)From screening and during treatment up to 2 years

    Defined as the time from first dose of PHST001 to first documentation of radiographic disease progression or death, whichever occurs first.

  • Overall Survival (OS) based on RECIST v1.1 to assess the preliminary antitumor activity of PHST001 in combination with chemotherapy (Phase 1b)From screening and during treatment up to 2 years

    Defined as the time from first dose of PHST001 to the date of death.