NCT03993873

Study of TPX-0022 in Patients With Advanced NSCLC, Gastric Cancer or Solid Tumors Harboring Genetic Alterations in MET

A Phase 1/2 of Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of TPX-0022 in Adult Subjects With Locally Advanced or Metastatic NSCLC, Gastric Cancer, or Solid Tumors Harboring Genetic Alterations in MET

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Turning Point Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase 1/2, first-in-human, open-label study of the safety, tolerability, PK, and efficacy of the novel MET/CSF1R/SRC inhibitor TPX-0022 in adult subjects with advanced or metastatic NSCLC, Gastric Cancer, or solid tumors harboring genetic alterations in MET. (SHIELD-I)

Detailed description

Dose Escalation: To evaluate the overall safety profile of TPX-0022, single and multiple dose PK profiles and preliminary efficacy in adults subjects with advanced solid tumors harboring genetic alterations in MET. Dose Expansion: To evaluate the preliminary efficacy and overall safety profile of TPX-0022 at the RP2D in defined cohorts of adult subjects in NSCLC, Gastric Cancer and advanced solid tumors harboring genetic alterations in MET.

Conditions

• Advanced Solid Tumor
• Metastatic Solid Tumors
• MET Gene Alterations

Interventions

Type	Name	Description
DRUG	elzovantinib (TPX-0022)	Oral elzovantinib (TPX-0022) capsules

Timeline

• Start date: 2019-09-05
• Primary completion: 2024-01-08
• Completion: 2027-03-03
• First posted: 2019-06-21
• Last updated: 2025-10-01

Locations

24 sites across 5 countries: United States, France, North Korea, South Korea, Spain

Regulatory

• FDA-regulated drug study