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

Neoplasms Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02635672
• Other study ID #: VNC-152-101
• Secondary ID: 2014-004808-30
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: February 10, 2016
• Est. completion date: December 30, 2024

Study information

• Verified date: August 2023
• Source: Vincerx Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Part 2 (Global), Part 3 (US Only), and Part 4 (US Only)

Inclusion Criteria:

• Male or female patients aged >/=18 years
• Patients with a histologically or cytologically confirmed solid tumor or aggressive NHL who are refractory to or have exhausted all available therapies with MYC expression or known C-MYC amplification/alterations
• Adequate bone marrow, liver, and renal functions
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 In the addition to the above Part 3 (US Only) and Part 4 (US Only)
• Must be eligible to use pembrolizumab per USPI

Exclusion Criteria:

• Active clinically serious infections of events > Grade 2
• Subjects who have new or progressive brain or meningeal or spinal metastases.
• Anticancer chemotherapy or immunotherapy during the study or within 1 weeks prior to the first dose of study drug
• Major surgery or significant trauma within 4 weeks before the first dose of study drug
• Allogeneic bone marrow transplant or stem cell rescue within 4 months before first dose of study drug; patients must have completed immunosuppressive therapy before enrollment.

Related Conditions & MeSH terms

• Neoplasms

Intervention

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.
• VIP152 (BAY 1251152) 30 mg
30 mg IV (30 minute infusion) fixed dose once weekly of a 21 day cycle.
• Keytruda
200 mg IV fixed dose once every 3 weeks of a 21 day cycle
• 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.

Locations

Country	Name	City	State
Chile	Centro de Investigaciones Clínicas Viña del Mar	Viña Del Mar	Valparaíso
Chile	Oncocentro	Viña del Mar
Spain	START Madrid- Fundación Jiménez Diaz	Madrid
United States	NEXT Oncology	Austin	Texas
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	Willamette Valley Cancer Institute	Eugene	Oregon
United States	John Theurer Cancer Center	Hackensack	New Jersey
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Norton Cancer Institute	Louisville	Kentucky
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Oregon Health and Science University	Portland	Oregon
United States	NEXT Oncology	San Antonio	Texas
United States	Maryland Oncology Hematology	Silver Spring	Maryland
United States	Avera Health	Sioux Falls	South Dakota
United States	Highlands Oncology Group	Springdale	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Vincerx Pharma, Inc.

Countries where clinical trial is conducted

United States,  Chile,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of DLT (Dose limit toxicity) of VIP152 (BAY1251152)		Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
Primary	Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP152 (BAY1251152)		Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
Primary	Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP152 (BAY1251152)		Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
Primary	AUC from time 0 to the last data point > Lower limit of quantitation (LLOQ) [AUC(0-tlast)] of VIP152 (BAY1251152)		Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
Primary	Maximum observed drug concentration in measured matrix after multiple dose administration during a dosage interval (Cmax,md) of VIP152 (BAY1251152)		Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
Primary	AUC from time 0 to the last data point > LLOQ after multiple dosing [AUC(0-tlast)md] of VIP152 (BAY1251152)		Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
Primary	Recommended phase 2 dose (RP2D) of VIP152 (BAY 1251152)		Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
Primary	Incidence of DLT (Dose limit toxicity) of VIP152 (BAY1251152) in combination with Keytruda® (pembrolizumab)		Cycle 1 Day 1 through Cycle 3 Day 1, where each cycle is up to 21 days
Primary	Recommended phase 2 dose (RP2D) of VIP152 (BAY 1251152) in combination with Keytruda® (pembrolizumab)		Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
Primary	Number of participants with adverse events as a measure safety and tolarability		Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 21 days (up to approximately 36 months)
Secondary	Tumor response evaluation based on the response criteria as applicable (RECIST v1.1 criteria for solid tumors and revised Lugano Classification for aggressive NHL)		Up to 3 Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 21 days (up to approximately 36 months)

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