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

Vincerx Pharma

Status and phase: Active, not recruiting; Phase 1

Conditions: Neoplasms

Treatments: Drug: VIP152 (BAY 1251152) 15 mg; Drug: VIP152 (BAY 1251152); Drug: Keytruda; Drug: VIP152 (BAY 1251152) 30 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02635672

VNC-152-101

2014-004808-30 (EudraCT Number)

Details and patient eligibility

About

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).

Full description

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).

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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110 participants in 4 patient groups

Dose escalation of VIP152 (BAY 1251152) / PART 1 (Completed)

Experimental group

Description:

Investigating VIP152 (BAY 1251152) in a dose escalation cohort in patients with solid tumors and aggressive NHL

Treatment:

Drug: VIP152 (BAY 1251152)

Dose expansion of VIP152 (BAY 1251152) / PART 2

Experimental group

Description:

Investigating VIP152 (BAY 1251152) in a dose expansion cohort in patients with solid tumors and aggressive NHL

Treatment:

Drug: VIP152 (BAY 1251152) 30 mg

Dose escalation of VIP152 (BAY 1251152) in combination with Keytruda® (pembrolizumab) / PART 3

Experimental group

Description:

Investigating combination VIP152 (BAY 1251152) and Keytruda® (pembrolizumab) in a dose escalation cohort in patients with advanced cancer. All subjects must be eligible to use pembrolizumab per USPI.

Treatment:

Drug: VIP152 (BAY 1251152) 15 mg

Drug: Keytruda

Dose expansion of VIP152 (BAY 1251152) in combination with Keytruda® (pembrolizumab) / PART 4

Experimental group

Description:

Investigating combination VIP152 (BAY 1251152) and Keytruda® (pembrolizumab) in a dose expansion cohort in patients with advanced cancer. All subjects must be eligible to use pembrolizumab per USPI.

Treatment:

Drug: VIP152 (BAY 1251152) 30 mg

Drug: Keytruda