A Study of IOV-5001 in Adults With Advanced Solid Tumors
- Sponsor
- Iovance Biotherapeutics, Inc.
- Study ID
- NCT07743723
- Phase
- PHASE1/PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Advanced Solid Tumors
- Colorectal Cancer
- Head and Neck Squamous Cell Carcinoma
- Metastatic Solid Tumors
- Non-Small Cell Lung Cancer
- Triple Negative Breast Cancer (TNBC)
- Unresectable Solid Tumor
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- IOV-5001 — BIOLOGICALIOV-5001 will be administered as 2 infusions, which will be administered in a hospital setting.
Study Details
A Phase 1/2, multicenter, multi-cohort, open-label study of an autologous tumor-infiltrating lymphocytes (TIL) regimen with IOV-5001 in participants with previously treated advanced solid tumors
Key Dates
- First listed
- Aug 4, 2026
- Start date
- Aug 31, 2026
- Status verified
- Aug 2026
- Primary completion
- Mar 31, 2034
- Completion
- Mar 31, 2044
Study Design
- Enrollment
- 106 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Phase 1: Safety Lead In
- Experimental: Phase 2: Non-Small Cell Lung Cancer (NSCLC)
- Experimental: Phase 2: Triple Negative Breast Cancer (TNBC)
- Experimental: Phase 2: Colorectal Cancer (CRC)
- Experimental: Phase 2: Head and Neck Squamous Cell Carcinoma (HNSCC)
Primary Outcome Measure
Phase 1: Safety Assessment [ Time Frame: Up to 30 days ]
Central Contacts
- Iovance Biotherapeutics Study Team844-845-4682
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