NCT02635672

Phase I Dose Escalation Study for VIP152 in Patients With Advanced Cancer

An Open-label, Multicenter Phase I Dose Escalation Study to Characterize Safety, Tolerability, Preliminary Anti-tumor Activity, Pharmacokinetics and Maximum Tolerated Dose of VIP152 (BAY 1251152) as Monotherapy or Combination Therapy in Subjects With Advanced Cancer.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Vincerx Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of VIP152 (BAY 1251152) as monotherapy or in combination in patients with solid tumors and aggressive non-hodgkin's lymphoma (NHL).

Detailed description

Part 2 VIP152 Monotherapy (Global). Part 3 dose escalation with VIP152 in combination with pembrolizumab (US only). Part 4 dose expansion with VIP152 in combination with pembrolizumab (US only).

Conditions

• Neoplasms

Interventions

Type	Name	Description
DRUG	VIP152 (BAY 1251152)	The starting dose of Cohort 1 will be 5 mg IV (30 minute infusion) fixed dose once weekly (5 mg/week) for 21 day cycles.
DRUG	VIP152 (BAY 1251152) 30 mg	30 mg IV (30 minute infusion) fixed dose once weekly of a 21 day cycle.
DRUG	Keytruda	200 mg IV fixed dose once every 3 weeks of a 21 day cycle
DRUG	VIP152 (BAY 1251152) 15 mg	The starting dose of Cohort 3 will be 15 mg IV (30 minute infusion) fixed dose once weekly (15 mg/week) for 21 day cycles.

Timeline

• Start date: 2016-02-10
• Primary completion: 2024-11-11
• Completion: 2024-11-11
• First posted: 2015-12-21
• Last updated: 2024-11-15

Locations

16 sites across 3 countries: United States, Chile, Spain

Regulatory

• FDA-regulated drug study