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

V

Vincerx Pharma

Status and phase

Active, not recruiting
Phase 1

Conditions

Neoplasms

Treatments

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

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)

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

Trial contacts and locations

16

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Central trial contact

Vincerx Clinical Trials Contact

Data sourced from clinicaltrials.gov

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