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VIP236

Phase 1

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

VIP236 target and mechanism

ModalitySmall molecule

Also known as VIP236 (Q3W)

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment29

FDA Designations

No designations recorded

VIP236 clinical trials

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 studied for the treatment of advanced solid tumors and other neoplasms. It is being developed by Vincerx Pharma, Inc. as an oncology therapy. The compound has been evaluated in a Phase 1 dose escalation study in patients with advanced cancer, but it is not approved for any indication.

Who is developing VIP236?

VIP236 is being developed by Vincerx Pharma, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol VINC. Vincerx is responsible for the clinical development of VIP236, including the Phase 1 trial conducted in the United States and Australia.

What phase is VIP236 in?

VIP236 is in Phase 1 clinical development. A single Phase 1 dose escalation study has been completed, enrolling 29 patients with advanced cancer. The trial was not randomized and did not use a double-blind design. VIP236 remains investigational and has not been approved by the FDA for any use.

What clinical trials is VIP236 in?

VIP236 has been evaluated in one clinical trial: NCT05712889, titled "Phase 1 Dose Escalation Study for VIP236 in Patients With Advanced Cancer." This completed Phase 1 trial enrolled 29 patients with neoplasms across sites in the United States and Australia. It was a controlled, non-randomized, open-label study in adults aged 18 years and older.

Is VIP236 the same as VIP236 (Q3W)?

Yes, VIP236 (Q3W) refers to the same investigational compound as VIP236. The Q3W designation indicates once every three weeks dosing, which was the schedule used in the Phase 1 clinical trial. Both names refer to the small molecule oncology candidate developed by Vincerx Pharma.