Phase I Dose Escalation Study for VIP152 in Patients With Advanced Cancer
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).
Checked against the public recordLast updated Nov 15, 2024 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Vincerx Pharma, Inc.
- Interventions being studied
- Drug: VIP152 (BAY 1251152); Drug: VIP152 (BAY 1251152) 30 mg; Drug: Keytruda; Drug: VIP152 (BAY 1251152) 15 mg
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Highlands Oncology GroupSpringdale, Arkansas
- Norton Cancer InstituteLouisville, Kentucky
- Maryland Oncology HematologySilver Spring, Maryland
- John Theurer Cancer CenterHackensack, New Jersey
- Memorial Sloan Kettering Cancer CenterNew York, New York
- University of Cincinnati Medical CenterCincinnati, Ohio
- Willamette Valley Cancer InstituteEugene, Oregon
- Oregon Health and Science UniversityPortland, Oregon
- Avera HealthSioux Falls, South Dakota
- Sarah Cannon Research InstituteNashville, Tennessee
- NEXT OncologyAustin, Texas
- University of Texas MD Anderson Cancer CenterHouston, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 15, 2024. Always confirm current availability with the study team.