NCT06433726

A Phase l Study of By101921, an Oral PARP7 Inhibitor, in Patients With Advanced Solid Tumors

A Phase Ⅰ, Multi-center, Open-label, Dose-escalation, Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Anti-tumor Activity of BY101921 Monotherapy in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Chengdu Baiyu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

BY101921 is a novel small molecule, being developed as a PARP7 inhibitor which acts on the PARP7 catalytic subunit, for the treatment of solid tumors. PARP7 is a member of the monoPARP family and involved in various biological processes such as gene expression, protein degradation, and cellular stress response. The results of non-clinical studies showed BY101921 was a potent inhibitor of PARP7 and had good selectivity. The primary objective is to assess the safety and tolerability and MTD of BY101921 in patients with refractory or metastatic solid tumors. This study will also evaluate pharmacokinetic (PK) profile, preliminary anti-tumor activity, major metabolites and biomarkers in patients with refractory or metastatic solid tumors.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	BY101921 tablets	An oral PARP7 Inhibitor

Timeline

• Start date: 2024-03-11
• Primary completion: 2025-06-30
• Completion: 2025-12-31
• First posted: 2024-05-30
• Last updated: 2024-05-30

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study