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

Sponsor

Vincerx Pharma, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT02635672

Collaborator

(none)

110

Enrollment

Locations

Arms

106.6

Anticipated Duration (Months)

8.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Neoplasms	Drug: VIP152 (BAY 1251152) Drug: VIP152 (BAY 1251152) 30 mg Drug: Keytruda Drug: VIP152 (BAY 1251152) 15 mg	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Feb 10, 2016

Anticipated Primary Completion Date :

Dec 30, 2024

Anticipated Study Completion Date :

Dec 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose escalation of VIP152 (BAY 1251152) / PART 1 (Completed) Investigating VIP152 (BAY 1251152) in a dose escalation cohort in patients with solid tumors and aggressive NHL	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.
Experimental: Dose expansion of VIP152 (BAY 1251152) / PART 2 Investigating VIP152 (BAY 1251152) in a dose expansion cohort in patients with solid tumors and aggressive NHL	Drug: VIP152 (BAY 1251152) 30 mg 30 mg IV (30 minute infusion) fixed dose once weekly of a 21 day cycle.
Experimental: Dose escalation of VIP152 (BAY 1251152) in combination with Keytruda® (pembrolizumab) / PART 3 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.	Drug: Keytruda 200 mg IV fixed dose once every 3 weeks of a 21 day cycle Other Names: pembrolizumab 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.
Experimental: Dose expansion of VIP152 (BAY 1251152) in combination with Keytruda® (pembrolizumab) / PART 4 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.	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 Other Names: pembrolizumab

Outcome Measures

Primary Outcome Measures

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]
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]
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]
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]
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]
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

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Highlands Oncology Group	Springdale	Arkansas	United States	72762
2	Norton Cancer Institute	Louisville	Kentucky	United States	40202
3	Maryland Oncology Hematology	Silver Spring	Maryland	United States	20904
4	John Theurer Cancer Center	Hackensack	New Jersey	United States	07601
5	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
6	University of Cincinnati Medical Center	Cincinnati	Ohio	United States	45219
7	Willamette Valley Cancer Institute	Eugene	Oregon	United States	97401
8	Oregon Health and Science University	Portland	Oregon	United States	97239
9	Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203
10	NEXT Oncology	Austin	Texas	United States	78758
11	University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030
12	NEXT Oncology	San Antonio	Texas	United States	78229
13	Centro de Investigaciones Clínicas Viña del Mar	Viña Del Mar	Valparaíso	Chile	2540364