Pheast Therapeutics
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.
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 com…
PHST001 is an anti-CD24 macrophage checkpoint inhibitor, administered as IV infusions every 3-weeks (Q3W) dosing intervals.
Participants will receive PHST001 at a dose level and schedule based on monotherapy data in Phase 1a. PHST001 will be combined with chemotherapeutic agents used as standard of care.