RecruitingPhase 1

A Study of PHST001 in Advanced Solid Tumors

United States272 participantsStarted 2025-03-31

Plain-language summary

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. The study's primary objective is to evaluate the safety and tolerability of PHST001 and determine the RP2D (Recommended Phase 2 dose) of PHST001 monotherapy and in combination with chemotherapy as well as assess the anti-tumor activity of PHST001 and chemotherapy in Phase 1b.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

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)

Timeframe: From first dose of PHST001 through 21 days after the first dose of PHST001

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)

Timeframe: From signed consent up to 90 days after the last dose of PHST001

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)

Timeframe: From first dose up to 90 days after the last dose of PHST001

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)

Timeframe: From first dose up to 90 days after the last dose of PHST001

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)

Timeframe: From first dose up to 90 days after the last dose of PHST001

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)

Trial details

NCT IDNCT06840886

SponsorPheast Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-04

Contact for this trial

Andrew Ferguson/VP Clinical Development, PhD

434-249-2349 medical@pheast.com

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