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IMP321

DRUG9 trials

Sponsors

Immutep, Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy, Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy, Immutep S.A.S., Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Conditions

Advanced/metastatic non-small cell lung cancer (NSCLC)HER2-neg/low metastatic breast cancerHealthyMelanomaMetastatic Breast CancerMetastatic head and neck squamous cell carcinoma (HNSCC)NSCLC AdenocarcinomaPeritoneal Carcinomatosis

Phase 1

IMP321 Plus First-line Paclitaxel in Metastatic Breast Carcinoma
CompletedNCT00349934
Immutep S.A.S.Metastatic Breast Cancer
Start: 2006-07-31End: 2010-01-31Updated: 2010-01-07
IMP321 Phase 1 Trial in Metastatic Renal Cell Carcinoma (MRCC)
CompletedNCT00351949
Immutep S.A.S.Stage IV Renal Cell Carcinoma
Start: 2005-09-30End: 2008-10-31Updated: 2010-01-07
Phase I Study of IMP321 Given Alone or as an Adjuvant to a Reference Flu Antigen
CompletedNCT00354263
Immutep S.A.S.Healthy
Start: 2005-04-30End: 2006-02-28Updated: 2008-04-24
Immunization of Disease-Free Melanoma Patients With Different HLA-A2 Peptides
TerminatedNCT00365937
Cliniques universitaires Saint-Luc- Université Catholique de LouvainMelanoma
Start: 2006-08-31End: 2013-12-13Updated: 2019-03-06
Feasibility and Safety of IMP321 (Eftilagimod Alpha) for Advanced Stage Solid Tumors
Active, not recruitingNCT03252938
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus NordwestNSCLC Adenocarcinoma, Peritoneal Carcinomatosis, Solid Tumors +1
Start: 2017-08-15End: 2026-09-30Updated: 2026-02-19

Phase 2

AIPAC-003: A randomized, double-blind, placebo-controlled Phase 3 trial testing eftilagimod alpha (soluble LAG-3) in HER2-neg/low metastatic breast cancer patients receiving paclitaxel, following an open-label dose optimization
Active, not recruitingCTIS2024-511023-34-00
ImmutepHER2-neg/low metastatic breast cancer
Start: 2023-05-05Target: 99Updated: 2025-10-20
TACTI-003 (Two ACTive Immunotherapeutics): A multicenter, open label, randomized, Phase II trial to investigate a soluble LAG-3 fusion protein, eftilagimod alpha (efti; IMP321) in combination with pembrolizumab (PD-1 antagonist) for first line treatment of subjects with unresectable recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC)
CompletedCTIS2024-510762-16-00
ImmutepMetastatic head and neck squamous cell carcinoma (HNSCC)
Start: 2021-11-30End: 2025-11-05Target: 127Updated: 2025-07-07
Phase II, Single-arm Clinical Trial Evaluating Efficacy and Safety of Pembrolizumab in Combination With a Soluble LAG-3 Protein, Eftilagimod Alpha, and Radiotherapy in Neoadjuvant Treatment of Patients With Soft Tissue Sarcomas (EFTISARC-NEO)
Active, not recruitingCTIS2024-515971-37-00
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy, Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut BadawczyResectable soft tissue sarcomas
Start: 2023-07-17Target: 40Updated: 2025-03-09

Phase 3

TACTI-004, a double-blinded, randomized phase 3 trial in patients with advanced/metastatic non-small cell lung cancer (NSCLC) receiving eftilagimod alfa (MHC class II agonist) in combination with pembrolizumab (PD-1 antagonist) and chemotherapy.
RecruitingCTIS2024-513621-23-00
ImmutepAdvanced/metastatic non-small cell lung cancer (NSCLC)
Start: 2025-04-18Target: 363Updated: 2026-01-12

Related Papers

TACTI-004: A double-blinded, randomized phase 3 trial in patients with advanced/metastatic non-small cell lung cancer receiving eftilagimod alfa (MHC class II agonist) in combination with pembrolizumab (P) and chemotherapy (C) versus placebo + P + C.
Journal of Clinical Oncology2025-05-28
INSIGHT-005: A new stratum of the explorative, open-labeled, phase I INSIGHT study to evaluate the feasibility and safety, as well as preliminary efficacy, of subcutaneous injections with IMP321 (eftilagimod alpha) in combination with PD-L1 inhibitor (avelumab) for metastatic or unresectable locally advanced urothelial carcinoma (UC)—IKF-s614.
Journal of Clinical Oncology2024-06-01
Phase I INSIGHT platform trial: Advanced safety and efficacy data from stratum D evaluating feasibility and safety of eftilagimod alpha (soluble LAG-3 protein) combined with avelumab in advanced solid tumors.
Journal of Clinical Oncology2021-05-202 citations
Open-label, phase I study evaluating feasibility and safety of subcutaneous IMP321 (LAG-3Ig fusion protein, eftilagimod alpha) combined with avelumab in advanced stage solid tumor entities: Results from stratum D of the INSIGHT platform trial.
Journal of Clinical Oncology2020-05-207 citations
The "INSIGHT" Trial: Two new strata of an explorative, open-labeled phase I study evaluating the feasibility and safety of subcutaneous IMP321 injections (LAG-3Ig fusion protein, eftilagimod alpha) combined with either standard-of-care drug therapy or PD-L1 inhibition (avelumab) in advanced-stage solid tumor entities.
Journal of Clinical Oncology2019-05-20
The "INSIGHT" trial: An explorative, open-labeled phase I study to evaluate the feasibility and safety of intra-tumoral, intra-peritoneal, and subcutaneous injections with IMP321 (LAG-3Ig fusion protein) for advanced stage solid tumor entities.
Journal of Clinical Oncology2018-05-201 citations
First-line chemoimmunotherapy in metastatic breast carcinoma: combination of paclitaxel and IMP321 (LAG-3Ig) enhances immune responses and antitumor activity.
2010-07-23183 citations