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

Completed · Phase 1

Conditions studied: Neoplasms

In brief

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).

Key facts

Study ID

NCT02635672

Run by

Vincerx Pharma, Inc.

People needed

110

Starts

2016-02-10

Expected to finish

2024-11-11

Last updated by the study team

2024-11-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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, Valparaiso, Chile
• Oncocentro — Viña del Mar, Chile
• START Madrid- Fundación Jiménez Diaz — Madrid, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.