Recruiting PHASE1 Advanced Solid Tumors

New treatment option for Advanced Solid Tumors

Official title A Study of PHST001 in Advanced Solid Tumors

ClinicalTrials.gov ID: NCT06840886

What this study is testing

What is PHST001?

PHST001 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumors.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 1: an early, usually small safety study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 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

You likely can't join if

  • Diagnosis of immunodeficiency
  • History of a previous additional malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years...
  • Active known CNS metastases and/or carcinomatous meningitis. Participants with previously treated CNS metastases may participate provided they are...
  • Received prior systemic anticancer therapy including investigational agents within 21 days or, if shorter, within 5 half-lives prior to the first...
  • Prior autologous or allogeneic hematopoietic stem cell transplant or solid organ transplant.
  • Received previous treatment with another agent targeting CD24.

The study team makes the final eligibility decision.

Where it's taking place

  • Beverly Hills, California, United States
  • Los Angeles, California, United States
  • Palo Alto, California, United States
  • Denver, Colorado, United States
  • New Haven, Connecticut, United States
  • Chicago, Illinois, United States
  • Boston, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Grand Rapids, Michigan, United States
  • Lake Success, New York, United States
  • New York, New York, United States
  • Durham, North Carolina, United States
  • Nashville, Tennessee, United States
  • Fort Worth, Texas, United States
  • Houston, Texas, United States
  • Irving, Texas, United States
  • San Antonio, Texas, United States
  • Fairfax, Virginia, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Beverly Hills, California, United States; Los Angeles, California, United States; Palo Alto, California, United States; Denver, Colorado, United States; New Haven, Connecticut, United States; Chicago, Illinois, United States and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.