Spots Global Cancer Trial Database for Clinical Study of SM3321 With Solid Tumors

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Trial Identification

Brief Title: Clinical Study of SM3321 With Solid Tumors

Official Title: An Open-label, Dose-escalation Phase Ia Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of SM3321 in Patients With Locally Advanced or Metastatic Solid Tumors

Study ID: NCT06087770

Conditions

Locally Advanced or Metastatic Solid Tumors

Interventions

SM3321

Study Description

Brief Summary: The purpose of this study is to evaluate the Safety and Tolerability of SM3321 in patients with locally advanced or metastatic solid tumors

Detailed Description: The goal of this clinical trial is to test patients with locally advanced or metastatic solid tumors. The main questions it aims to answer are: * To evaluate the safety and tolerability of SM3321 in patients with locally advanced or metastatic solid tumors. * To determine dose-limiting toxicities (DLTs) , Maximum tolerated dose(MTD) and Recommended phase 2 dose (RP2D)of SM3321 in the treatment of patients with locally advanced or metastatic solid tumors. . * To evaluate the Pharmacokinetics (PK) profile of SM3321 in patients with locally advanced or metastatic solid tumors after single and multiple administration. * To evaluate the immunogenicity of single and multiple administration of SM3321 in patients with locally advanced or metastatic solid tumors. * To evaluate the initial antitumor activity of SM3321 in patients with locally advanced or metastatic solid tumors. * To further evaluate serum biomarkers and explore the potential relationship between these markers and the antitumor activity and safety of SM3321. * To explore the relationship between dose and/or PK exposure and effects(including anti-tumor activity and safety).