NCT05231733

Study of SPX-101 in Subjects With Advanced or Refractory Solid Tumors

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: SparX Biotech(Jiangsu) Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	SPX-101	Subjects will receive SPX-101 on Day 1 of the first cycle, and will be evaluated for DLTs in the following 3 weeks. After the first cycle, subjects will continue treatment at dosing intervals as determined by safety and PK results. All patients will continue treatment until disease progression, development of unacceptable toxicity, or until in the opinion of the investigator the patient is no longer benefiting from therapy, or at patient discretion (maximum duration: 2 years).

Timeline

• Start date: 2022-05-01
• Primary completion: 2024-04-01
• Completion: 2024-08-01
• First posted: 2022-02-09
• Last updated: 2024-10-31

Regulatory

• FDA-regulated drug study