FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W4379281074> ?p ?o ?g. }

• W4379281074 endingPage "TPS9599" @default.
• W4379281074 startingPage "TPS9599" @default.
• W4379281074 abstract "TPS9599 Background: ANV419 is a potent and selective IL-2Rβγ targeted antibody IL-2 fusion protein, designed to enable the delivery of high dose interleukin-2 (IL-2) to patients in order to stimulate anti-tumour response and minimise toxicities. Recombinant IL-2 (proleukin) induces durable responses in approximately 10% of patients with melanoma. Signalling through IL-2Rα expressing cells is believed to limit its therapeutic potential in cancer. By eliminating binding to IL-2Rα, ANV419 could lead to increased anti-tumor effect while increasing tolerability. The ANV419-001 first-in-human study (NCT 04855929) demonstrated that ANV419 preferentially stimulates cytotoxic CD8+ T and natural killer (NK) cells over immunosuppressive regulatory T cells, with a significantly longer half-life than that of conventional IL-2. The safety and tolerability data from this study confirmed that ANV419 delivers high molar equivalents of IL-2 in a tolerable and convenient way. Methods: ANV419 is being evaluated in a global multicentre, open-label, randomized Phase I/II study in patients with unresectable or metastatic cutaneous melanoma to assess the safety and efficacy of intravenous ANV419 as monotherapy and in combination with anti-PD1 or anti-CTLA-4 antibodies. The OMNIA-1 study leads in with a monotherapy dose expansion part, followed by a combination dose-finding with either anti-PD-1 or anti-CTLA-4 and a combination dose expansion part. ANV419 is administered intravenously every 2 weeks as monotherapy and every 3 weeks when given in combination. Patients with advanced cutaneous melanoma, no active brain metastases and whose disease has progressed on or following at least 1 line of standard of care immunotherapy are eligible. In Part 1, a total of 30 patients will be randomised and evaluated for response to Q2W ANV419 monotherapy (108 µg/kg or 243 µg/kg). In Part 2, escalating doses of Q3W ANV419 are evaluated to define the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) in combination with pembrolizumab (200 mg) or ipilimumab (3 mg/kg). In Part 3, the efficacy and safety of ANV419 in combination with the approved doses pembrolizumab or ipilimumab will be evaluated using a Simon’s 2-stage design. Up to 130 patients are planned to be enrolled. Patients will be stratified according to BRAF mutation status. AEs are assessed according to CTCAE V5.0. Tumour response is determined using RECIST 1.1 criteria. The study is conducted at sites in the US, France, Spain, Germany, Italy, and UK. The first patient was dosed in December 2022. Preliminary monotherapy efficacy data are expected by Q1/2024. Clinical trial information: NCT05578872 ." @default.
• W4379281074 created "2023-06-05" @default.
• W4379281074 creator A5008736570 @default.
• W4379281074 creator A5010592319 @default.
• W4379281074 creator A5018040758 @default.
• W4379281074 creator A5046869656 @default.
• W4379281074 creator A5054850662 @default.
• W4379281074 creator A5056132643 @default.
• W4379281074 creator A5056227404 @default.
• W4379281074 creator A5082347575 @default.
• W4379281074 date "2023-06-01" @default.
• W4379281074 modified "2023-10-01" @default.
• W4379281074 title "OMNIA-1: A phase I/II study, an IL-2R-βγ targeted antibody-IL-2 fusion protein, as monotherapy or in combination with anti-PD-1 or anti-CTLA-4 antibodies, in patients with advanced melanoma." @default.
• W4379281074 doi "https://doi.org/10.1200/jco.2023.41.16_suppl.tps9599" @default.
• W4379281074 hasPublicationYear "2023" @default.
• W4379281074 type Work @default.
• W4379281074 citedByCount "0" @default.
• W4379281074 crossrefType "journal-article" @default.
• W4379281074 hasAuthorship W4379281074A5008736570 @default.
• W4379281074 hasAuthorship W4379281074A5010592319 @default.
• W4379281074 hasAuthorship W4379281074A5018040758 @default.
• W4379281074 hasAuthorship W4379281074A5046869656 @default.
• W4379281074 hasAuthorship W4379281074A5054850662 @default.
• W4379281074 hasAuthorship W4379281074A5056132643 @default.
• W4379281074 hasAuthorship W4379281074A5056227404 @default.
• W4379281074 hasAuthorship W4379281074A5082347575 @default.
• W4379281074 hasConcept C121608353 @default.
• W4379281074 hasConcept C126322002 @default.
• W4379281074 hasConcept C143998085 @default.
• W4379281074 hasConcept C154317977 @default.
• W4379281074 hasConcept C159654299 @default.
• W4379281074 hasConcept C167672396 @default.
• W4379281074 hasConcept C185592680 @default.
• W4379281074 hasConcept C197934379 @default.
• W4379281074 hasConcept C202751555 @default.
• W4379281074 hasConcept C203014093 @default.
• W4379281074 hasConcept C2776999253 @default.
• W4379281074 hasConcept C2777371288 @default.
• W4379281074 hasConcept C2777658100 @default.
• W4379281074 hasConcept C2777701055 @default.
• W4379281074 hasConcept C2778375690 @default.
• W4379281074 hasConcept C29730261 @default.
• W4379281074 hasConcept C31760486 @default.
• W4379281074 hasConcept C502942594 @default.
• W4379281074 hasConcept C55493867 @default.
• W4379281074 hasConcept C71924100 @default.
• W4379281074 hasConcept C8891405 @default.
• W4379281074 hasConcept C98274493 @default.
• W4379281074 hasConceptScore W4379281074C121608353 @default.
• W4379281074 hasConceptScore W4379281074C126322002 @default.
• W4379281074 hasConceptScore W4379281074C143998085 @default.
• W4379281074 hasConceptScore W4379281074C154317977 @default.
• W4379281074 hasConceptScore W4379281074C159654299 @default.
• W4379281074 hasConceptScore W4379281074C167672396 @default.
• W4379281074 hasConceptScore W4379281074C185592680 @default.
• W4379281074 hasConceptScore W4379281074C197934379 @default.
• W4379281074 hasConceptScore W4379281074C202751555 @default.
• W4379281074 hasConceptScore W4379281074C203014093 @default.
• W4379281074 hasConceptScore W4379281074C2776999253 @default.
• W4379281074 hasConceptScore W4379281074C2777371288 @default.
• W4379281074 hasConceptScore W4379281074C2777658100 @default.
• W4379281074 hasConceptScore W4379281074C2777701055 @default.
• W4379281074 hasConceptScore W4379281074C2778375690 @default.
• W4379281074 hasConceptScore W4379281074C29730261 @default.
• W4379281074 hasConceptScore W4379281074C31760486 @default.
• W4379281074 hasConceptScore W4379281074C502942594 @default.
• W4379281074 hasConceptScore W4379281074C55493867 @default.
• W4379281074 hasConceptScore W4379281074C71924100 @default.
• W4379281074 hasConceptScore W4379281074C8891405 @default.
• W4379281074 hasConceptScore W4379281074C98274493 @default.
• W4379281074 hasIssue "16_suppl" @default.
• W4379281074 hasLocation W43792810741 @default.
• W4379281074 hasOpenAccess W4379281074 @default.
• W4379281074 hasPrimaryLocation W43792810741 @default.
• W4379281074 hasRelatedWork W1795265027 @default.
• W4379281074 hasRelatedWork W1973091934 @default.
• W4379281074 hasRelatedWork W2124779813 @default.
• W4379281074 hasRelatedWork W2327853898 @default.
• W4379281074 hasRelatedWork W2800079817 @default.
• W4379281074 hasRelatedWork W3048051248 @default.
• W4379281074 hasRelatedWork W3158438576 @default.
• W4379281074 hasRelatedWork W3180719608 @default.
• W4379281074 hasRelatedWork W4291367166 @default.
• W4379281074 hasRelatedWork W4360983034 @default.
• W4379281074 hasVolume "41" @default.
• W4379281074 isParatext "false" @default.
• W4379281074 isRetracted "false" @default.
• W4379281074 workType "article" @default.