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IOV-3001

Phase 1

Unresectable Melanoma | Monoclonal antibody | Oncology |Iovance Biotherapeutics, Inc.|Last Updated: Jun 15, 2026

Target and mechanism

Molecular targetIL-2R
Target classReceptor
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

Clinical trial landscape

IOV-3001 · 1 trial · 3 indications

Phase 1 1
NCT06940739A Study to Investigate the Safety and Efficacy of IOV-3001 in Adults With Advanced Melanoma Who Will Receive LifileucelUnresectable Melanoma
RECRUITING42 Analytics
PHASE1RECRUITING
A Study to Investigate the Safety and Efficacy of IOV-3001 in Adults With Advanced Melanoma Who Will Receive Lifileucel
Unresectable MelanomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and Tolerability
Up to 30 days

The frequency and severity of treatment emergent adverse events and serious adverse events will be assessed when IOV-3001 administered

Recommended Dose for Phase 2
Up to 30 days

Determine the recommended dose for Phase 2

Secondary Endpoints

Pharmacokinetics (PK) profile of IOV-3001
Up to 8 days
Pharmacodynamic (PD) Profile of IOV-3001
Up to 8 days
Antidrug Antibody (ADA) Profile
Up to 5 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeOTHER

Treatment Arms

ArmTypeDescription
Assigned InterventionsEXPERIMENTALDose escalation participants with unresectable or metastatic melanoma

Interventions

NameTypeDescription
IOV-3001BIOLOGICALIOV-3001 will be administered as a single dose by IV infusion, which will be administered in a hospital setting.
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: 1. Participant must be ≥ 18 years of age at the time of signing the informed consent. 2. Participant has unresectable or metastatic melanoma. 3. Participant has melanoma not of uveal/ocular origin and experienced documented radiographic disease progression during systemic therap...

Countries:United StatesAustralia
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Recent Changes (Last 90 Days)

LOWJun 16, 2026NCT06940739lastUpdatePostDate: changed
LOWJun 16, 2026NCT06940739lastUpdatePostDate: changed
LOWJun 16, 2026NCT06940739lastUpdatePostDate: changed
LOWJun 16, 2026NCT06940739lastUpdatePostDate: changed

Frequently asked questions about IOV-3001

What is IOV-3001 used for?

IOV-3001 is an investigational monoclonal antibody being developed for the treatment of unresectable melanoma, including metastatic melanoma and ocular melanoma. It is currently being studied in a Phase 1 clinical trial in adults with advanced melanoma who will also receive lifileucel.

What does IOV-3001 target?

IOV-3001 targets the IL-2 receptor (IL-2R), a receptor involved in immune cell signaling. By binding to IL-2R, the antibody is designed to modulate immune responses, which may be relevant in the context of cancer treatment for melanoma.

Who makes IOV-3001?

IOV-3001 is being developed by Iovance Biotherapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IOVA. The company is conducting clinical research on this investigational therapy for melanoma.

What phase is IOV-3001 in?

IOV-3001 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to evaluate its safety and efficacy.

What clinical trials is IOV-3001 in?

IOV-3001 is being studied in a single Phase 1 clinical trial with the identifier NCT06940739. This trial is recruiting adults with advanced melanoma, including unresectable, metastatic, and ocular melanoma, and is being conducted in the United States and Australia.

Is IOV-3001 the same as lifileucel?

No, IOV-3001 is not the same as lifileucel. IOV-3001 is a monoclonal antibody targeting IL-2R, while lifileucel is a separate therapy. In the clinical trial, patients receive IOV-3001 in combination with lifileucel, but they are distinct investigational agents.