This is a first-in-human, multicenter, open-label Phase Ia/Ib study evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary antitumor activity of SM2275 in patients with advanced or metastatic solid tumors who have progressed after standard therapy or for whom no standard treatment is available.
Phase Ia includes dose escalation to evaluate safety, identify dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D). Phase Ib will further evaluate safety, PK, PD, and preliminary antitumor activity in expansion cohorts.
Inclusion Criteria:
Exclusion Criteria:
xiaodan.liu@starmab.com.cn
Phase Ia (Dose Escalation): Approximately 15-42 patients. Open-label, multiple dose-escalation design based on body-weight preset dose levels to determine DLT, MTD, and RP2D. Phase Ib (Dose Expansion): Approximately 30 patients. Expansion at the recommended dose (RP2D) determined by the investigator and sponsor in selected solid tumor cohorts.
yanbin.liang@starmab.com.cn86-13910340137
A First-in-human Phase I Study to Evaluate EMB-15 in Patients With Locally Advanced or Metastatic Solid Tumors.