CompletedPhase 1NCT02635672

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

StatusCompleted
PhasePhase 1
U.S. locations16
SponsorVincerx Pharma, Inc.
01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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