Clinical trial NCT06840886: A Study of PHST001 in Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Pheast Therapeutics
Sponsor class: INDUSTRY
First posted: 2025-02-21
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Dose levels are 0.1 mg/kg, 0.3 mg/kg, 1.0 mg/kg, 2.0 mg/kg, 4.0 mg/kg, 6.0 mg/kg, 9.0 mg/kg
Primary purpose: TREATMENT

Brief summary: PHST001-101 is a multicenter, open-label, Phase 1 study of PHST001 in patients with advanced solid tumors. The study design includes a Dose Escalation Phase and a Dose Expansion Phase, and will enroll patients with advanced relapsed and/or refractory solid tumors. The study's primary object is to evaluate the safety and tolerability of PHST001 and determine the RP2D (Recommended Phase 2 dose) of PHST001.


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 hepatic function:
* AST and ALT ≤ 2.5 × times ULN (≤ 5 × ULN if liver metastases)
* Total bilirubin ≤ 1.5 × ULN (\<3 ×ULN for patients with elevations due to Gilbert syndrome)
* Lipase and amylase ≤ 2×ULN
* Adequate renal function: calculated creatinine clearance of ≥ 30 mL/min calculated per institutional standard
* Adequate bone marrow function without packed RBC transfusion within the prior 2 weeks. Patients can be on a stable dose of erythropoietin (approximately ≥ 3 months). Criteria must be met without platelet transfusion within 7 days of screening blood draw:
* Absolute neutrophil count (ANC) ≥1,500/µL
* Platelet count ≥100,000/µL
* Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/La

Key Exclusion Criteria:

* History of a previous additional malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years. Patients 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. Patients 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. Patients with previously treated CNS metastases may participate provided they are radiologically stable (ie, 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. Patients must have recovered from all AEs due to previous therapies to Grade ≤1 or baseline. Patients with Grade ≤2 neuropathy may be eligible. Patients 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.

Primary outcomes:
measure: AE
timeFrame: 90 days after the last dose of PHST001
measure: DLT
timeFrame: 21 days after the first dose of PHST001
Secondary outcomes:
measure: RECIST v1.1
timeFrame: From screening and during treatment up to 2 years
measure: PK
timeFrame: From treatment until 90 days after last dose of PHST001
measure: PD
timeFrame: From treatment until end of treatment of up to 2 years of PHST001
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics (START)
state: Texas
Study officials:
References: