Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT05231733
Brief Summary:
A Phase 1, Open-label Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of an anti-Claudin 18.2 Antibody SPX-101 in Patients with Advanced or Refractory Solid Tumors
Detailed Description:
This is an open-label, dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of various doses of SPX-101 in patients with advanced or refractory solid tumors.
This study will determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and select the recommended Phase2 dose (RP2D).
Up to five dose levels will be explored (1, 3, 9, 18, 30 mg/kg dose levels) depending on the number and intensity of observed toxicities.
A total of up to 27 patients will be enrolled in this study. Subjects will receive SPX-101 by IV infusion in 60-minutes（±15 minutes）on Day 1 of the first cycle (3 weeks), and will be evaluated for DLTs in 3 weeks (DLT window). After the first cycle, subjects will continue the treatment at the assigned dose level.
Study:
NCT05231733
Study Brief:
Protocol Section:
NCT05231733