NCT06087770

Clinical Study of SM3321 With Solid Tumors

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Beijing StarMab Biomed Technology Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Locally Advanced or Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	SM3321	Intravenous infusion, once a week, 28 days for a dosing cycle

Timeline

• Start date: 2023-12-07
• Primary completion: 2025-08-19
• Completion: 2025-10-14
• First posted: 2023-10-18
• Last updated: 2023-12-18

Locations

3 sites across 1 country: China

Regulatory

• FDA-regulated drug study