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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
Neoplasms
NCT02635672110
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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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Competitive Landscape -Myeloproliferative Neoplasms 52 trials (matched to "Neoplasms")
CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY5PHASE3ACE-536
AbbVie, Inc.ABBV4PHASE3Navitoclax, Ruxolitinib
Novartis AG Sponsored ADRNVS3PHASE3Pelabresib, Ruxolitinib
Karyopharm Therapeutics, Inc.KPTI4PHASE3Selinexor, Ruxolitinib
Geron CorporationGERN2PHASE3Imetelstat
Merck & Co., Inc.MRK1PHASE3Bomedemstat
Incyte CorporationINCY10PHASE2Ruxolitinib
GSK plc Sponsored ADRGSK2PHASE2MMB
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK1PHASE2Elritercept, Ruxolitinib
Eli Lilly and CompanyLLY1PHASE1LY3410738, Venetoclax, Azacitidine
Disc Medicine, Inc.IRON1PHASE1DISC-0974
Galecto, Inc.GLTO1PHASE2GB2064
Prelude Therapeutics, Inc.PRLD1PHASE1PRT12396
United Therapeutics CorporationUTHR1PHASE2bomedemstat
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