Drugs / simlukafusp alfa
last change Feb 2025 re-read 9 days ago

simlukafusp alfa

Protein / enzyme biologic targets FAP

Developed for
breast cancer · cancer · head and neck cancer · metastatic melanoma · pancreatic adenocarcinoma · renal cell carcinoma
Investigated by
Hoffmann-La Roche

Trials 6

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT03875079 Jun 2019 → Jul 2022 metastatic melanoma Hoffmann-La Roche Completed No outcome recorded
Phase 1 NCT03063762 Mar 2017 → Jun 2021 renal cell carcinoma Hoffmann-La Roche Completed No outcome recorded
Phase 1 NCT02627274 Dec 2015 → Nov 2022 breast cancer, head and neck cancer Hoffmann-La Roche Completed No outcome recorded
Phase 1/21 trial · 1 missed
Phase 1/2 NCT03193190 Jul 2017 → Feb 2025 pancreatic adenocarcinoma Hoffmann-La Roche Completed Missed primary
Phase 21 trial
Phase 2 NCT03386721 Feb 2018 → Dec 2021 — Hoffmann-La Roche Terminated No outcome recorded Stop: Business
Phase 31 trial
Phase 3 NCT03768063 Feb 2019 → Jul 2028 expected cancer Hoffmann-La Roche Active not recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2025-02-24 Cellectis S.A. Results Cellectis Presents ‘Smart CAR T’ Strategy to Enhance Efficacy Against Solid Tumors at AACR-IO 2025 cellectis.com ↗
CAR induced expression of synthetically engineered FAP-IL2v immunocytokine boosts persistent anti-tumor activity of TALEN-edited allogeneic CAR T-cells without associated IL-2 toxicity

All press releases naming this drug 1 release

DateIssuerRelease

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 8 sources stand behind the page.

FieldValueCited text
Known as simlukafusp alfa ClinicalTrials.gov intervention name — accepted as the source's own label NCT03386721 ↗
Known as FAP-IL2v “BACKGROUND: Simlukafusp alfa (FAP-IL2v) is an immune cytokine engineered to selectively promote immune responses in the tumour microenvironment.” PMID 39395231 ↗ Oct 2024
1

NCT03768063 ↗

Known as FAP-IL2V FP RO6874281 ChEMBL registry synonym — accepted as the source's own label CHEMBL4298090 ↗
Known as RG-7461 ChEMBL registry synonym — accepted as the source's own label CHEMBL4298090 ↗
Known as RO6874281 ClinicalTrials.gov intervention name — accepted as the source's own label NCT03193190 ↗
3

NCT03875079 ↗

NCT02627274 ↗

NCT03063762 ↗

Modality Protein / enzyme biologic “RO6874281, an Immunocytokine Consisting of Interleukin 2 Variant (IL-2v)” NCT02627274 ↗
Route Intravenous “RO6874281 will be administered as an intravenous (IV) infusion.” NCT02627274 ↗
Target FAP “Targeting Fibroblast Activation Protein-α (FAP)” NCT02627274 ↗