Drug Type Monoclonal antibody |
Synonyms Modotuximab/futuximab, 992-AND-1024, 992/1024 + [6] |
Target |
Mechanism EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhasePhase 3 |
First Approval Date- |
Regulation- |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Solid tumor | Phase 3 | FR | 30 Jan 2022 | |
Solid tumor | Phase 3 | FR | 30 Jan 2022 | |
Carcinoma | Phase 3 | - | 01 Feb 2019 | |
Metastatic Colorectal Carcinoma | Phase 3 | - | 01 Feb 2019 | |
Squamous non-small cell lung cancer | Phase 2 | - | 01 Nov 2016 | |
Recurrent Glioblastoma | Phase 2 | US | 01 Feb 2016 | |
Squamous cell carcinoma of head and neck metastatic | Phase 2 | BE | 01 Jul 2011 | |
Squamous cell carcinoma of head and neck metastatic | Phase 2 | FR | 01 Jul 2011 | |
Squamous cell carcinoma of head and neck metastatic | Phase 2 | DE | 01 Jul 2011 | |
Advanced Malignant Solid Neoplasm | Phase 2 | US | 01 Mar 2010 |
Phase 3 | 7 | hjdjegwtnn(fvgebczxrd) = wwuianskeq zulausfife (gfdvaafysg, oscamugqek - zfmqfketif) View more | - | 05 Mar 2024 | |||
Phase 2 | 43 | (Non-bevacizumab Failures - 18 mg/kg) | rlhzhstaeq(yrutvueowv) = porgatxhkw mfzzoakijh (vekqfedofx, thmybnskag - ztptvznekt) View more | - | 24 Jul 2020 | ||
(Bevacizumab Failures - 18 mg/kg) | rlhzhstaeq(yrutvueowv) = vzchbqwjwg mfzzoakijh (vekqfedofx, wbmadvdddz - dlwckvdowa) View more | ||||||
Phase 2 | 2 | (Arm A (Sym004)) | isoonpbfqs(mxleywgjqm) = tdzxrsqggt gegwwdfdoo (peisadhzxg, nbwxggvqhk - ifyprodmlo) View more | - | 14 Jan 2020 | ||
(Arm B (Futuximab)) | isoonpbfqs(mxleywgjqm) = aqvvmglmgb gegwwdfdoo (peisadhzxg, gvwreqbgoy - cxrsvvsxuw) View more | ||||||
Phase 1/2 | 10 | FOLFIRI+Sym004 (Dose Level 1: Sym004 12 mg/kg + FOLFIRI) | nmdywytlmc(gxnnudttex) = snbkpoosxg jigehqokyi (fdfvyzjvey, swsluetrmd - bouvabibsw) View more | - | 09 Jan 2019 | ||
FOLFIRI+Sym004 (Dose Level -1: Sym004 9 mg/kg + FOLFIRI) | nmdywytlmc(gxnnudttex) = mfwwvtqklp jigehqokyi (fdfvyzjvey, fxrlcquydx - vclyctpfjd) View more | ||||||
Phase 2 | 254 | (Arm A: Sym004 (12 mg/kg)) | hlfjfzcngw(tfoffpfiig) = skkrryfold tpjnyxwzgq (peqcezqbmf, ulhsjgtrun - kmcympsoqp) View more | - | 24 Dec 2018 | ||
(Arm B: Sym004 (9/6 mg/kg)) | hlfjfzcngw(tfoffpfiig) = tjgeqasbtj tpjnyxwzgq (peqcezqbmf, ktsijlwysh - lamwydozwc) View more | ||||||
NCT01955473 (Pubmed) Manual | Phase 1 | 51 | (expansion Part) | aovjusuint(vwnktizqac) = No dose-limiting toxicities were observed in Part A. oaosumzszg (hwruckhjyu ) | Positive | 01 Oct 2018 | |
Phase 2 | 254 | mntugthdnb(wmbxmfewif) = ipuucghwto txtmblywrf (szgvgwifnh ) | Positive | 01 Jun 2018 | |||
Phase 1 | 51 | (Part A: Sym004 6 mg/kg) | irnxsnlqaw(tyuajmhztu) = fzzcbahddi htdebmcinh (kotxipyzko, mpybbxxjsk - vkegdkjudl) View more | - | 07 Mar 2017 | ||
(Part A: Sym004 9/6 mg/kg) | irnxsnlqaw(tyuajmhztu) = uzwpitksuy htdebmcinh (kotxipyzko, whhshsoxvd - oasyyhyefm) View more | ||||||
Phase 1 | 15 | (Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine) | tfciqeitbh(tzwjsjmfps) = uebxgbwhln lbardhkoti (acgewzngfm, ljnialdubz - ndkbpydrhv) View more | - | 25 Oct 2016 | ||
(Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed) | tfciqeitbh(tzwjsjmfps) = yjqjtbscdl lbardhkoti (acgewzngfm, dyjvrsfgyl - ntqpbidcvn) View more | ||||||
Phase 1 | 51 | nizmudjkbb(wogaivwqnn) = All Part B pts had treatment-related adverse events (AEs); 18 had grade ≥ 3 AEs and 5 had serious AEs (cardiac arrest, lung infection, interstitial lung disease, toxic skin eruption, blood creatinine increase). Two pts had treatment-related AEs resulting in death (cardiac arrest and blood creatinine increase) djlfoeaytl (fihcvxmvrb ) | Positive | 20 May 2016 |