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

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: VIP152 (BAY 1251152); Drug: VIP152 (BAY 1251152) 30 mg; Drug: Keytruda; Drug: VIP152 (BAY 1251152) 15 mg

• Registration Number: NCT02635672
• Lead Sponsor: Vincerx Pharma, Inc.

Brief 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).

Study Timeline

• Study First Submitted: 2015-12-17
• Study First Submitted QC: 2015-12-17
• Study First Posted: 2015-12-21
• Study Start: 2016-02-10
• Status Verified: 2024-11
• Primary Completion: 2024-11-11
• Study Completion: 2024-11-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose escalation of VIP152 (BAY 1251152) / PART 1 (Completed)	VIP152 (BAY 1251152)	Investigating VIP152 (BAY 1251152) in a dose escalation cohort in patients with solid tumors and aggressive NHL
Dose expansion of VIP152 (BAY 1251152) / PART 2	VIP152 (BAY 1251152) 30 mg	Investigating VIP152 (BAY 1251152) in a dose expansion cohort in patients with solid tumors and aggressive NHL
Dose escalation of VIP152 (BAY 1251152) in combination with Keytruda® (pembrolizumab) / PART 3	Keytruda	Investigating combination VIP152 (BAY 1251152) and Keytruda® (pembrolizumab) in a dose escalation cohort in patients with advanced cancer. All subjects must be eligible to use pembrolizumab per USPI.
Dose escalation of VIP152 (BAY 1251152) in combination with Keytruda® (pembrolizumab) / PART 3	VIP152 (BAY 1251152) 15 mg	Investigating combination VIP152 (BAY 1251152) and Keytruda® (pembrolizumab) in a dose escalation cohort in patients with advanced cancer. All subjects must be eligible to use pembrolizumab per USPI.
Dose expansion of VIP152 (BAY 1251152) in combination with Keytruda® (pembrolizumab) / PART 4	VIP152 (BAY 1251152) 30 mg	Investigating combination VIP152 (BAY 1251152) and Keytruda® (pembrolizumab) in a dose expansion cohort in patients with advanced cancer. All subjects must be eligible to use pembrolizumab per USPI.
Dose expansion of VIP152 (BAY 1251152) in combination with Keytruda® (pembrolizumab) / PART 4	Keytruda	Investigating combination VIP152 (BAY 1251152) and Keytruda® (pembrolizumab) in a dose expansion cohort in patients with advanced cancer. All subjects must be eligible to use pembrolizumab per USPI.

Primary Outcome Measures

Name	Time	Method
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
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
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
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
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
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
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
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
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
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (15)

John Theurer Cancer Center; 🇺🇸 Hackensack, New Jersey, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Avera Health; 🇺🇸 Sioux Falls, South Dakota, United States

Highlands Oncology Group; 🇺🇸 Springdale, Arkansas, United States

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Oncocentro; 🇨🇱 Viña del Mar, Chile

START Madrid- Fundación Jiménez Diaz; 🇪🇸 Madrid, Spain

Norton Cancer Institute; 🇺🇸 Louisville, Kentucky, United States

Maryland Oncology Hematology; 🇺🇸 Silver Spring, Maryland, United States

Willamette Valley Cancer Institute; 🇺🇸 Eugene, Oregon, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

NEXT Oncology; 🇺🇸 San Antonio, Texas, United States

Centro de Investigaciones Clínicas Viña del Mar; 🇨🇱 Viña Del Mar, Valparaíso, Chile

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States