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

An Open-label, Multicenter Phase I Dose Escalation Study to Characterize Safety, Tolerability, Preliminary Anti-tumor Activity, Pharmacokinetics and Maximum Tolerated Dose of VIP152 (BAY 1251152) as Monotherapy or Combination Therapy in Subjects 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).

Part 2 VIP152 Monotherapy (Global). Part 3 dose escalation with VIP152 in combination with pembrolizumab (US only). Part 4 dose expansion with VIP152 in combination with pembrolizumab (US only).

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.