Phase I Dose Escalation Study for VIP152 in Patients With Advanced Cancer
NCT ID: NCT02635672
Last Updated: 2024-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
110 participants
INTERVENTIONAL
2016-02-10
2024-11-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies
NCT06034275
Phase 1 Dose Escalation Study for VIP236 in Patients With Advanced Cancer
NCT05712889
A Study of the Safety and Pharmacokinetics of GDC-0152, Administered Intravenously to Patients With Locally Advanced or Metastatic Malignancies
NCT00977067
TTP607 in Refractory Solid Malignancies
NCT00939172
Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced Cancer
NCT01938638
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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.
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
VIP152 (BAY 1251152) 30 mg
30 mg IV (30 minute infusion) fixed dose once weekly of a 21 day cycle.
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.
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.
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.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Vincerx Pharma, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Vincerx Study Director
Role: STUDY_DIRECTOR
Vincerx Pharma, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Highlands Oncology Group
Springdale, Arkansas, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Maryland Oncology Hematology
Silver Spring, Maryland, United States
John Theurer Cancer Center
Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Willamette Valley Cancer Institute
Eugene, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Avera Health
Sioux Falls, South Dakota, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
NEXT Oncology
Austin, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
Centro de Investigaciones Clínicas Viña del Mar
Viña del Mar, Región de Valparaíso, Chile
Oncocentro
Viña del Mar, , Chile
START Madrid- Fundación Jiménez Diaz
Madrid, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Diamond JR, Boni V, Lim E, Nowakowski G, Cordoba R, Morillo D, Valencia R, Genvresse I, Merz C, Boix O, Frigault MM, Greer JM, Hamdy AM, Huang X, Izumi R, Wong H, Moreno V. First-in-Human Dose-Escalation Study of Cyclin-Dependent Kinase 9 Inhibitor VIP152 in Patients with Advanced Malignancies Shows Early Signs of Clinical Efficacy. Clin Cancer Res. 2022 Apr 1;28(7):1285-1293. doi: 10.1158/1078-0432.CCR-21-3617.
Related Links
Access external resources that provide additional context or updates about the study.
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014-004808-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VNC-152-101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.