Trial intelligence / Profile preview

IOV-5001 in Advanced Solid Tumors

NCT07743723Phase 2

Key facts

Status: Not yet recruiting
Start: Sep 2026
Primary completion: Mar 2034
Countries: 1
Sponsor: Iovance Biotherapeutics

Drugs: TIGIT double-edited tumor-infiltrating lymphocytes
Conditions: solid tumornon-small cell lung cancer (NSCLC)triple-negative breast cancer (TNBC)colorectal cancer (CRC)head and neck squamous cell carcinoma (HNSCC)

Overview

Phase 2, open-label trial of TIGIT double-edited tumor-infiltrating lymphocytes in solid tumor, non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC) and 2 more (5 arms), sponsored by Iovance Biotherapeutics. Primary endpoints: Safety Assessment at 30 days and Overall Response Rate at 5 years. Planned start Sep 2026; status: not yet recruiting.

Design

5 arms

Study design: Non-randomizedOpen-label

Phase 1: Safety Lead In
Phase 1 safety lead-in cohort receiving IOV-5001
Phase 2: Non-Small Cell Lung Cancer (NSCLC)
Phase 2 cohort of NSCLC patients receiving IOV-5001
Phase 2: Triple Negative Breast Cancer (TNBC)
Phase 2 cohort of TNBC patients receiving IOV-5001
Phase 2: Colorectal Cancer (CRC)
Phase 2 cohort of CRC patients receiving IOV-5001
Phase 2: Head and Neck Squamous Cell Carcinoma (HNSCC)
Phase 2 cohort of HNSCC patients receiving IOV-5001

Who it enrols

Adults with previously treated advanced solid tumors (NSCLC, TNBC, CRC, HNSCC) with radiographic disease progression, ECOG 0-1, and at least one resectable lesion for TIL generation.

Endpoints

Primary

Safety Assessment30 days
Overall Response Rate5 years

Secondary

Complete Response Rate5 years
Duration of Response5 years
Disease Control Rate5 years
Progression-Free Survival5 years
Overall Survival5 years
Safety and Tolerability5 years
Product FeasibilityDay 0

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