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VIP152

Phase 1

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

VIP152 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2021

VIP152 target and mechanism

Molecular targetP-TEFb/CDK9
Target classProtein
ModalitySmall molecule

Also known as VIP152 (BAY 1251152)

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment110

FDA Designations

No designations recorded

VIP152 clinical trials

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 studied in oncology for the treatment of neoplasms, specifically advanced cancer. It is being developed by Vincerx Pharma, Inc. as a potential therapy for patients with advanced solid tumors and other cancers, and it has been evaluated in a Phase 1 dose escalation study.

What does VIP152 target?

VIP152 targets P-TEFb/CDK9, a protein complex involved in regulating transcription. By inhibiting CDK9 within the P-TEFb complex, VIP152 is designed to disrupt transcription of genes that cancer cells rely on for growth and survival, which is the mechanistic rationale for its study in advanced cancers.

Who is developing VIP152?

VIP152 is being developed by Vincerx Pharma, Inc., a biopharmaceutical company whose common stock trades under the ticker symbol VINC. Vincerx Pharma is the sponsor of the clinical program evaluating VIP152 in patients with advanced cancer.

What phase is VIP152 in?

VIP152 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. The Phase 1 program consisted of a dose escalation study in patients with advanced cancer, and the drug remains in early-stage clinical evaluation.

What clinical trials is VIP152 in?

VIP152 has been studied in the Phase 1 trial NCT02635672, titled "Phase I Dose Escalation Study for VIP152 in Patients With Advanced Cancer." The trial enrolled 110 patients with neoplasms across the United States, Chile, and Spain, and it is now completed.

Is VIP152 the same as BAY 1251152?

Yes, VIP152 is also known as BAY 1251152. The compound was originally developed by Bayer as BAY 1251152 and later became known as VIP152 under development by Vincerx Pharma, Inc. Both names refer to the same small molecule CDK9 inhibitor being studied in advanced cancer.