Phase 1a1b Study of PHST001 Alone or with Chemotherapy in Adults With Advanced or Resistant Solid Tumors

What this Trial Is About

Researchers are evaluating PHST001, an anti-CD24 macrophage checkpoint inhibitor, for its safety, pharmacokinetics, pharmacodynamics, and antitumor activity in adults with advanced relapsed or refractory solid tumors. This Phase 1a1b open-label study includes participants with various solid tumors, including CNS tumors in Phase 1a, and focuses on ovarian, endometrial, and cholangiocarcinoma cancers in Phase 1b. The study aims to determine the recommended Phase 2 dose and assess safety and tolerability of PHST001 alone and combined with chemotherapy. PHST001 is given as intravenous infusions every three weeks. In Phase 1a, nine escalating dose levels will be tested as monotherapy. Phase 1b includes combination treatments with chemotherapy drugs such as paclitaxel, topotecan, doxorubicin, FOLFIRI, FOLFOX, and gemcitabine. The study has a safety run-in phase followed by tumor-specific expansion cohorts at a fixed PHST001 dose combined with chemotherapy. Participants will undergo screening and receive study treatment with ongoing safety monitoring. Researchers will assess dose-limiting toxicities, adverse events, and antitumor activity using RECIST or RANO criteria over up to two years. Pharmacokinetic parameters of PHST001 will also be measured. Safety will be observed up to 90 days after the last dose. The total participation duration varies based on treatment and follow-up.

A Study of PHST001 in Advanced Solid Tumors