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

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ClinicalTrials.gov Identifier: NCT02635672
Recruitment Status : Recruiting
First Posted : December 21, 2015
Last Update Posted : March 31, 2022
Sponsor:
Information provided by (Responsible Party):
Vincerx Pharma, Inc.

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 10, 2016
Estimated Primary Completion Date : December 30, 2024
Estimated Study Completion Date : December 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: pembrolizumab


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of DLT (Dose limit toxicity) of VIP152 (BAY1251152) [ Time Frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days ]
  2. Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP152 (BAY1251152) [ Time Frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days ]
  3. Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP152 (BAY1251152) [ Time Frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days ]
  4. AUC from time 0 to the last data point > Lower limit of quantitation (LLOQ) [AUC(0-tlast)] of VIP152 (BAY1251152) [ Time Frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days ]
  5. Maximum observed drug concentration in measured matrix after multiple dose administration during a dosage interval (Cmax,md) of VIP152 (BAY1251152) [ Time Frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days ]
  6. AUC from time 0 to the last data point > LLOQ after multiple dosing [AUC(0-tlast)md] of VIP152 (BAY1251152) [ Time Frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days ]
  7. Recommended phase 2 dose (RP2D) of VIP152 (BAY 1251152) [ Time Frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days ]
  8. Incidence of DLT (Dose limit toxicity) of VIP152 (BAY1251152) in combination with Keytruda® (pembrolizumab) [ Time Frame: Cycle 1 Day 1 through Cycle 3 Day 1, where each cycle is up to 21 days ]
  9. Recommended phase 2 dose (RP2D) of VIP152 (BAY 1251152) in combination with Keytruda® (pembrolizumab) [ Time Frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days ]
  10. Number of participants with adverse events as a measure safety and tolarability [ Time Frame: 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 :
  1. Tumor response evaluation based on the response criteria as applicable (RECIST v1.1 criteria for solid tumors and revised Lugano Classification for aggressive NHL) [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02635672


Contacts
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Contact: Vincerx Clinical Trials Contact (+) 1-650-800-6676 clinicaltrials@vincerx.com

Locations
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United States, Arkansas
Highlands Oncology Group Recruiting
Springdale, Arkansas, United States, 72762
Contact: Research site         
United States, Kentucky
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40202
Contact: Research Site         
United States, Maryland
Maryland Oncology Hematology Recruiting
Silver Spring, Maryland, United States, 20904
Contact: Research site         
United States, New Jersey
John Theurer Cancer Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Research site         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Research site         
United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Research site         
United States, Oregon
Willamette Valley Cancer Institute Recruiting
Eugene, Oregon, United States, 97401
Contact: Research site         
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Research site         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Research Site         
United States, Texas
NEXT Oncology Recruiting
Austin, Texas, United States, 78758
Contact: Research Site         
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Research site         
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
Contact: Research Site         
Chile
Centro de Investigaciones Clínicas Viña del Mar Recruiting
Viña Del Mar, Valparaíso, Chile, 2540364
Contact: Research site         
Sponsors and Collaborators
Vincerx Pharma, Inc.
Investigators
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Study Director: Vincerx Study Director Vincerx Pharma, Inc.
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Vincerx Pharma, Inc.
ClinicalTrials.gov Identifier: NCT02635672    
Other Study ID Numbers: VNC-152-101
2014-004808-30 ( EudraCT Number )
First Posted: December 21, 2015    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vincerx Pharma, Inc.:
Solid tumors
Aggressive non-hodgkin's lymphoma (NHL)
Advanced Ovarian Cancer
Triple Negative Breast Cancer
DHL
Double-Hit Lymphoma
Transformed Follicular Lymphoma
Mantle Cell
Prostate Cancer
Melanoma
Non-small Cell Lung Cancer
Head and Neck Squamous Cell Cancer
Esophageal Cancer
Urothelial Carcinoma
Tumor Mutational Burden-High Cancer
 Cutaneous Squamous Cell Carcinoma
Microsatellite Instability-High or Mismatch Repair Deficient Cancer
Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer
Gastric Cancer
Cervical Cancer
Hepatocellular Carcinoma
Merkel Cell Carcinoma
Renal Cell Carcinoma
Endometrial Carcinoma
MYC overexpression
MYC amplification
MYC translocation
Classic Hodgkins
Primary Mediastinal Large B Cell Lymphoma
Additional relevant MeSH terms:
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Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents