MedTrace Logo

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

NCT06433726 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-05-30

No results posted yet for this study

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

DRUG

BY101921 tablets

An oral PARP7 Inhibitor

Sponsors & Collaborators

  • Chengdu Baiyu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-11
Primary Completion
2025-06-30
Completion
2025-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06433726 on ClinicalTrials.gov