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

NCT02635672 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2024-11-15

No results posted yet for this study

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).

Conditions

  • Neoplasms

Interventions

DRUG

VIP152 (BAY 1251152)

The starting dose of Cohort 1 will be 5 mg IV (30 minute infusion) fixed dose once weekly (5 mg/week) for 21 day cycles.

DRUG

VIP152 (BAY 1251152) 30 mg

30 mg IV (30 minute infusion) fixed dose once weekly of a 21 day cycle.

DRUG

Keytruda

200 mg IV fixed dose once every 3 weeks of a 21 day cycle

DRUG

VIP152 (BAY 1251152) 15 mg

The starting dose of Cohort 3 will be 15 mg IV (30 minute infusion) fixed dose once weekly (15 mg/week) for 21 day cycles.

Sponsors & Collaborators

  • Vincerx Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Vincerx Study Director · Vincerx Pharma, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-10
Primary Completion
2024-11-11
Completion
2024-11-11
FDA Drug
Yes

Countries

  • United States
  • Chile
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02635672 on ClinicalTrials.gov