Open Actively Recruiting

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

About

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).

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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.

Join this Trial

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Study Stats
Protocol No.
22-000580
Category
Hematology-Oncology
Oncology
Contact
Shenetra Walker
Location
  • UCLA Westwood
For Providers
NCT No.
NCT02635672
For detailed technical eligibility, visit ClinicalTrials.gov.