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VIP152

Phase 1

Neoplasms | Small molecule | Oncology |Vincerx Pharma, Inc.|Last Updated: Nov 15, 2024

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment110

FDA Designations

No designations recorded

Clinical trial landscape

VIP152 · 1 trial · 1 indication

Phase 1 1
NCT02635672Phase I Dose Escalation Study for VIP152 in Patients With Advanced CancerNeoplasms
COMPLETED110 Analytics
PHASE1COMPLETED
Phase I Dose Escalation Study for VIP152 in Patients With Advanced Cancer
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of DLT (Dose limit toxicity) of VIP152 (BAY1251152)
Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP152 (BAY1251152)
Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP152 (BAY1251152)
Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
AUC from time 0 to the last data point > Lower limit of quantitation (LLOQ) [AUC(0-tlast)] of VIP152 (BAY1251152)
Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
Maximum observed drug concentration in measured matrix after multiple dose administration during a dosage interval (Cmax,md) of VIP152 (BAY1251152)
Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
AUC from time 0 to the last data point > LLOQ after multiple dosing [AUC(0-tlast)md] of VIP152 (BAY1251152)
Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
Recommended phase 2 dose (RP2D) of VIP152 (BAY 1251152)
Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
Incidence of DLT (Dose limit toxicity) of VIP152 (BAY1251152) in combination with Keytruda® (pembrolizumab)
Cycle 1 Day 1 through Cycle 3 Day 1, where each cycle is up to 21 days
Recommended phase 2 dose (RP2D) of VIP152 (BAY 1251152) in combination with Keytruda® (pembrolizumab)
Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
Number of participants with adverse events as a measure safety and tolarability
Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 21 days (up to approximately 36 months)

Secondary Endpoints

Tumor response evaluation based on the response criteria as applicable (RECIST v1.1 criteria for solid tumors and revised Lugano Classification for aggressive NHL)
Up to 3 Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 21 days (up to approximately 36 months)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose escalation of VIP152 (BAY 1251152) / PART 1 (Completed)EXPERIMENTALInvestigating VIP152 (BAY 1251152) in a dose escalation cohort in patients with solid tumors and aggressive NHL
Dose expansion of VIP152 (BAY 1251152) / PART 2EXPERIMENTALInvestigating VIP152 (BAY 1251152) in a dose expansion cohort in patients with solid tumors and aggressive NHL
Dose escalation of VIP152 (BAY 1251152) in combination with Keytruda® (pembrolizumab) / PART 3EXPERIMENTALInvestigating 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.
Dose expansion of VIP152 (BAY 1251152) in combination with Keytruda® (pembrolizumab) / PART 4EXPERIMENTALInvestigating 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.

Interventions

NameTypeDescription
VIP152 (BAY 1251152)DRUGThe starting dose of Cohort 1 will be 5 mg IV (30 minute infusion) fixed dose once weekly (5 mg/week) for 21 day cycles.
VIP152 (BAY 1251152) 30 mgDRUG30 mg IV (30 minute infusion) fixed dose once weekly of a 21 day cycle.
KeytrudaDRUG200 mg IV fixed dose once every 3 weeks of a 21 day cycle
VIP152 (BAY 1251152) 15 mgDRUGThe starting dose of Cohort 3 will be 15 mg IV (30 minute infusion) fixed dose once weekly (15 mg/week) for 21 day cycles.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites16

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 k...

Countries:United StatesChileSpain
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Frequently asked questions about VIP152

What is VIP152 used for?

VIP152 is an investigational small molecule being developed for the treatment of neoplasms, which are abnormal growths of tissue that can be cancerous. It is currently in clinical development for oncology indications, specifically targeting advanced cancer in patients.

Who makes VIP152?

VIP152 is being developed by Vincerx Pharma, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol VINC. The company is focused on advancing this oncology therapy through clinical development.

What phase is VIP152 in?

VIP152 is in Phase 1 clinical development. It has completed a Phase 1 dose escalation study in patients with advanced cancer. As an investigational drug, it is not yet approved by regulatory authorities and remains in clinical trials.

What clinical trials is VIP152 in?

VIP152 has been studied in a Phase 1 dose escalation trial with the identifier NCT02635672. This completed trial enrolled 110 participants with neoplasms across the United States, Chile, and Spain, and included adult patients of all sexes.

Is VIP152 FDA approved?

VIP152 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial. Further clinical development and regulatory review would be required before it could be considered for approval.