NCT06235437

Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ASD141

A Phase 1, First-in-Human, Open-label, Doseescalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ASD141 in Subjects With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Ascendo Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I study designed to evaluate if ASD141 is safe, tolerable, and efficacious in participants with advanced solid tumors.

Detailed description

This is a multicenter, first-in-human (FIH), open-label, non-randomized, dose escalation study of ASD141 to evaluate safety, tolerability, and preliminary anti-tumor activity of ASD141 in subjects with advanced solid tumors. The study includes 8 dose cohorts.

Conditions

• Metastatic Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	ASD141	Subjects will receive one of 8 dose levels of ASD141.

Timeline

• Start date: 2024-08-29
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2024-02-01
• Last updated: 2026-01-07

Locations

2 sites across 1 country: Taiwan

Regulatory

• FDA-regulated drug study