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VIP236

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 Enrollment29

FDA Designations

No designations recorded

Clinical trial landscape

VIP236 · 1 trial · 1 indication

Phase 1 1
NCT05712889Phase 1 Dose Escalation Study for VIP236 in Patients With Advanced CancerNeoplasms
COMPLETED29 Analytics
PHASE1COMPLETED
Phase 1 Dose Escalation Study for VIP236 in Patients With Advanced Cancer
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of DLT (Dose limit toxicity) of VIP236
Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
Number of participants with adverse events as a measure safety and tolerability
Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 10 months)

Secondary Endpoints

Objective response rate (ORR), defined as the proportions of subjects who have a best overall response of partial response (PR) or complete response (CR) as determined by investigators using RECIST 1.1
Up to 24 onths
Disease control rate (DCR) per RECIST v1.1, defined as best overall response of complete response (CR), partial response (PR), or stable disease (SD) as determined by Investigator review.
Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 10 months)
Progression-free survival per RECIST v1.1, defined as the time from enrollment to documented disease progression or death from any cause, whichever occurs earlier as determined by Investigator review
Up to 24 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose Escalation of VIP236 (Q3W)EXPERIMENTALInvestigating VIP236 in a dose escalation cohort in subjects with advanced solid tumor cancer. Dosing occurs on D1 of each 21-day cycle
Dose Escalation of VIP236 (Q2W)EXPERIMENTALInvestigating VIP236 in a dose escalation cohort in subjects with advanced solid tumor cancer. Dosing occurs on D1 and D15 of each 28-day cycle.

Interventions

NameTypeDescription
VIP236 (Q3W)DRUGVIP236 will be administered by IV infusion once every 3 weeks, for a 21-day cycle.
VIP236 (Q2W)DRUGVIP236 will be administered by IV infusion once every 2 weeks, for a 28-day cycle.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Adult patients aged \>/=18 years, able to provide informed consent and willing to comply with all study procedures. * Histologically confirmed advanced or metastatic solid tumors that are relapsed or refractory to standard of care. Subjects must have exhausted all available st...

Countries:United StatesAustralia
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Frequently asked questions about VIP236

What is VIP236 used for?

VIP236 is an investigational small molecule being developed for the treatment of neoplasms, which are abnormal growths of tissue that can be benign or malignant. It is currently being studied in patients with advanced cancer as part of a Phase 1 clinical trial.

What does VIP236 target?

VIP236 is a small molecule, but its specific molecular target has not been disclosed. The drug is being investigated for its potential to treat neoplasms, and its mechanism of action is not publicly detailed in the available information.

Who makes VIP236?

VIP236 is being developed by Vincerx Pharma, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol VINC on the NASDAQ stock exchange.

What phase is VIP236 in?

VIP236 is in Phase 1 clinical development. A Phase 1 dose escalation study has been completed, which involved 29 patients with advanced cancer. The drug is still investigational and has not been approved by regulatory authorities.

What clinical trials is VIP236 in?

VIP236 has been studied in a Phase 1 dose escalation trial with the identifier NCT05712889. This trial, titled 'Phase 1 Dose Escalation Study for VIP236 in Patients With Advanced Cancer,' was conducted in the United States and Australia and has been completed.

Is VIP236 the same as any other drug?

VIP236 is not known to have any alternative names. It is a distinct investigational compound being developed by Vincerx Pharma, Inc. for the treatment of neoplasms.