NCT02797795

A Phase 1, Open-Label, Dose-Escalation Study of NEV801, Administered to Patients With Advanced Cancers

A Phase 1, Open-Label, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered NEV801 in Subjects With Advanced Malignancies

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Neovia Oncology Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a first-in-human, multicenter, open-label, nonrandomized, dose-escalation trial to be conducted in 2 sequential parts: * Part A (Dose Escalation) in subjects with advanced malignancies * Part B (Dose Confirmation) in subjects with tumor type(s) to be determined by results of Part A

Detailed description

In Part A, subjects will be treated with a 30-minute intravenous (IV) infusion of NEV801 on Days 1, 8, 15, and 22 of continuous 28-day cycles. The starting dose of NEV801 will be 20 mg/m2/dose, and the NEV801 dose will be escalated in successive cohorts of 3 subjects per dose level. In Part B, up to 3 expansion cohorts of up to 12 subjects each, defined by tumor type, will be enrolled at or below the MTD (i.e., the RP2D) of NEV801. In both parts, subjects who tolerate the drug and who do not experience progressive disease may continue to receive NEV801 at the discretion of the Investigator for up to 12 cycles. Subjects who tolerate the drug and experience clinical benefit will be eligible for further treatment in an extension protocol or through another means to be determined by the Sponsor.

Conditions

• Advanced Cancer
• Solid Tumors

Interventions

Type	Name	Description
DRUG	NEV801	Dose Escalation

Timeline

• Start date: 2016-12-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2016-06-13
• Last updated: 2021-03-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study