NCT05383898

Study to Evaluate D-1553 in Subjects With Lung Cancer

A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 in Subjects With Advanced or Metastatic Solid Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: InventisBio Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1/2, open label study of D-1553 single agent treatment to assess the safety and tolerability, identify the MTD and RP2D, evaluate the PK properties and antitumor activities in subjects with advanced or metastatic NSCLC with KRasG12C mutation

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	D-1553	D-1553 is a novel, targeted KRasG12C inhibitor that is being developed as a potential oral agent for advanced or metastatic solid tumors with KRasG12C mutation.

Timeline

• Start date: 2021-03-16
• Primary completion: 2023-11-17
• Completion: 2024-05-17
• First posted: 2022-05-20
• Last updated: 2024-10-15

Locations

2 sites across 1 country: China

Regulatory

• FDA-regulated drug study