NCT04840004

Efficacy and Safety of PVT-1 Treatment in Patients With Advanced Non-Small Cell Lung Cancer

Efficacy and Safety of PVT-1 Treatment in Patients With Advanced and Refractory Non-Small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: PlusVitech S.L. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Lung cancer is one of the most common causes of cancer death worldwide. It is projected that the vast majority, approximately 80% -85% of all lung cancer diagnosis is Non-Small Cell Lung Cancer (NSCLC). Although there are significant improvements in the treatment of Lung Cancer in recent years, there is still an unmet medical need for a specific population which has advanced NSCLC and mostly is refractory to existing treatments. In NSCLC the molecular profile is important to direct the treatment. Specifically, for cases with an EGFR+, ALK+, ROS1+ or PD1/PDL1+ molecular profile, targeted treatments are available. PVT-1 is a safe, orally administrable and well-tolerated drug directed against a specific therapeutic target of cancer cells what has demonstrated efficacy in NSCLC with a molecular profile EGFR-, ALK-, ROS1- and refractory to anti-PD1 / PDL1, in last line, which also represents the highest percentage of patients and with the highest chances of cancer progression with currently available treatments.

Conditions

• Non Small Cell Lung Cancer
• Advanced Cancer
• Refractory Cancer

Interventions

Type	Name	Description
DRUG	PVT-1	Since there is no specific dose range is available for testing the anti-tumor effects of PVT-1 in clinical trials settings, in the present study the dose of PVT-1 will be up-titrated 250/160/160 mg to maximum 1000/640/640 mg as described in study methodology section.

Timeline

• Start date: 2021-03-10
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2021-04-09
• Last updated: 2023-04-05

Locations

4 sites across 1 country: Turkey (Türkiye)