2023
161TiP A phase I/II, open-label study of an anti-ILT2 (LILRB1) antibody, SAR444881, administered alone and in combination with pembrolizumab, with or without chemotherapy, or cetuximab in patients with advanced solid tumors
Perets R, Stemmer S, Geva R, Golan T, Fakih M, Cohen J, Lieu C, Jin Z, Lorusso P, Ashtamker N, Friedman I, Hakim M, Crawford N, Perez R, Agarwal M, Abbadessa G, Wu M, Lin J, Deantonio C, Borad M. 161TiP A phase I/II, open-label study of an anti-ILT2 (LILRB1) antibody, SAR444881, administered alone and in combination with pembrolizumab, with or without chemotherapy, or cetuximab in patients with advanced solid tumors. Immuno-Oncology Technology 2023, 20: 100672. DOI: 10.1016/j.iotech.2023.100672.Peer-Reviewed Original Research673P A phase I dose-escalation and expansion study evaluating the safety and efficacy of the MDM2–p53 antagonist brigimadlin (BI 907828) in patients (pts) with solid tumours
Schoeffski P, Lorusso P, Yamamoto N, Lugowska I, Garcia V, Lauer U, Hu C, Jayadeva G, Lahmar M, Gounder M. 673P A phase I dose-escalation and expansion study evaluating the safety and efficacy of the MDM2–p53 antagonist brigimadlin (BI 907828) in patients (pts) with solid tumours. Annals Of Oncology 2023, 34: s472-s473. DOI: 10.1016/j.annonc.2023.09.1859.Peer-Reviewed Original Research1029P Dazostinag (TAK-676) alone and in combination with pembrolizumab (pembro) in patients (pts) with advanced or metastatic solid tumors: Preliminary safety, PK/PD, and anti-tumor activity in a phase I dose escalation study supporting a recommended dose for expansion (RDE)
Olszanski A, Luke J, LoRusso P, Falchook G, Bedard P, Sanborn R, Patel S, Orr D, Gibbs J, Li C, Huang Y, Gregory R, Perera S, Xu R, Joshi A, Lee M, Raizer J, Gao X. 1029P Dazostinag (TAK-676) alone and in combination with pembrolizumab (pembro) in patients (pts) with advanced or metastatic solid tumors: Preliminary safety, PK/PD, and anti-tumor activity in a phase I dose escalation study supporting a recommended dose for expansion (RDE). Annals Of Oncology 2023, 34: s625-s626. DOI: 10.1016/j.annonc.2023.09.2168.Peer-Reviewed Original ResearchPlatinum Sensitivity in IDH1/2 Mutated Intrahepatic Cholangiocarcinoma: Not All “BRCAness” Is Created Equal
Doroshow D, Wei W, Mehrotra M, Sia D, Eder J, Bindra R, Houldsworth J, LoRusso P, Walther Z. Platinum Sensitivity in IDH1/2 Mutated Intrahepatic Cholangiocarcinoma: Not All “BRCAness” Is Created Equal. Cancer Investigation 2023, 41: 646-655. PMID: 37505929, DOI: 10.1080/07357907.2023.2242957.Peer-Reviewed Original ResearchConceptsClinical benefit rateIntrahepatic cholangiocarcinomaPlatinum sensitivityUnresectable intrahepatic cholangiocarcinomaObjective response rateMulticenter retrospective studyHomologous recombination repairDefective homologous recombination (HR) repairPrimary endpointPlatinum chemotherapyRetrospective studyPreclinical dataBenefit rateWildtype tumorsResponse rateMT tumorsWT diseasePatientsGene defectsCholangiocarcinomaTumorsThe MDM2–p53 antagonist BI 907828 in patients with advanced or metastatic solid tumors: results of a phase Ia, first-in-human, dose-escalation study
LoRusso P, Yamamoto N, Patel M, Laurie S, Bauer T, Geng J, Davenport T, Teufel M, Li J, Lahmar M, Gounder M. The MDM2–p53 antagonist BI 907828 in patients with advanced or metastatic solid tumors: results of a phase Ia, first-in-human, dose-escalation study. Cancer Discovery 2023, 13: 1802-1813. PMID: 37269344, PMCID: PMC10401071, DOI: 10.1158/2159-8290.cd-23-0153.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsSolid tumorsDay 1Common treatment-related adverse eventsGrowth differentiation factor-15 levelsMDM2-p53 antagonistsManageable safety profileAdvanced solid tumorsDose-escalation studyDose-limiting toxicityMetastatic solid tumorsDose-dependent increaseIA/IBAdverse eventsSafety profilePreliminary efficacyDedifferentiated liposarcomaClinical investigationCommon gradePatientsRelated commentaryIssue featureTarget engagementAntitumor activityTumors42O A phase Ia/b, dose-escalation and expansion study evaluating the MDM2–p53 antagonist BI 907828 in patients with solid tumours: Safety and efficacy in patients with dedifferentiated liposarcoma (DDLPS)
Schoeffski P, Yamamoto N, Bauer T, Patel M, Lorusso P, Lahmar M, Durland-Busbice S, Geng J, Gounder M. 42O A phase Ia/b, dose-escalation and expansion study evaluating the MDM2–p53 antagonist BI 907828 in patients with solid tumours: Safety and efficacy in patients with dedifferentiated liposarcoma (DDLPS). ESMO Open 2023, 8: 101079. DOI: 10.1016/j.esmoop.2023.101079.Peer-Reviewed Original Research
2022
748 A phase 1/2, open-label, dose-escalation, safety and tolerability study of NC762 in subjects with advanced or metastatic solid tumors
Myint H, Shah S, Gutierrez M, Zsiros E, Nelson M, Zeidan S, Myrthil N, Morawski A, Barbu A, Shaik J, Zhou C, Kanellopoulou C, Copeland R, Cusumano Z, Flies D, Langermann S, Lorusso P, Odunsi K. 748 A phase 1/2, open-label, dose-escalation, safety and tolerability study of NC762 in subjects with advanced or metastatic solid tumors. 2022, a781-a781. DOI: 10.1136/jitc-2022-sitc2022.0748.Peer-Reviewed Original Research770 Safety, efficacy, and pharmacokinetic results from a phase I first-in-human study of ABBV-151 with or without anti-PD1 mAb (budigalimab) in patients with locally advanced or metastatic solid tumors
Tolcher A, Roda-Perez D, He K, Moreno V, Gomez-Roca C, Machiels J, Razak A, Sahtout M, Guan X, Jaryno-Daly S, Leibman R, Blaney M, O’Brien J, Lorusso P, Powderly J, Golan T, Miller K, Bruix J. 770 Safety, efficacy, and pharmacokinetic results from a phase I first-in-human study of ABBV-151 with or without anti-PD1 mAb (budigalimab) in patients with locally advanced or metastatic solid tumors. 2022, a801-a801. DOI: 10.1136/jitc-2022-sitc2022.0770.Peer-Reviewed Original Research452O A phase I dose-escalation and expansion study evaluating the safety and efficacy of the MDM2–p53 antagonist BI 907828 in patients (pts) with solid tumours
Schoeffski P, Yamamoto N, Bauer T, Patel M, Gounder M, Geng J, Sailer R, Jayadeva G, Lorusso P. 452O A phase I dose-escalation and expansion study evaluating the safety and efficacy of the MDM2–p53 antagonist BI 907828 in patients (pts) with solid tumours. Annals Of Oncology 2022, 33: s743. DOI: 10.1016/j.annonc.2022.07.581.Peer-Reviewed Original Research
2021
958O Coordinated activation of antitumor responses of g9d2 and CD8 T-cells by targeting BTN3A with ICT01 in patients with solid tumors: EVICTION trial
Marabelle A, Wermke M, Jungels C, de Bono J, Vey N, Garralda E, Lorusso P, Olive D, Frohna P. 958O Coordinated activation of antitumor responses of g9d2 and CD8 T-cells by targeting BTN3A with ICT01 in patients with solid tumors: EVICTION trial. Annals Of Oncology 2021, 32: s829-s830. DOI: 10.1016/j.annonc.2021.08.1343.Peer-Reviewed Original ResearchMO24-1 Phase I/IIa trial evaluating safety and clinical activity of DuoBody®-PD-L1×4-1BB (GEN1046) in advanced solid tumors
Melero I, Geva R, Ben-Ami E, Maurice-Dror C, Calvo E, LoRusso P, Tureci O, Niewood M, Sahin U, Jure-Kunkel M, Forssmann U, Ahmadi T, Alonso G. MO24-1 Phase I/IIa trial evaluating safety and clinical activity of DuoBody®-PD-L1×4-1BB (GEN1046) in advanced solid tumors. Annals Of Oncology 2021, 32: s313. DOI: 10.1016/j.annonc.2021.05.625.Peer-Reviewed Original Research
2020
7LBA Late Breaking Milademetan, an oral MDM2 inhibitor, in well-differentiated/ dedifferentiated liposarcoma: results from a phase 1 study in patients with solid tumors or lymphomas
Gounder M, Bauer T, Schwartz G, LoRusso P, Kumar P, Kato K, Tao B, Hong Y, Patel P, Hong D. 7LBA Late Breaking Milademetan, an oral MDM2 inhibitor, in well-differentiated/ dedifferentiated liposarcoma: results from a phase 1 study in patients with solid tumors or lymphomas. European Journal Of Cancer 2020, 138: s3-s4. DOI: 10.1016/s0959-8049(20)31080-7.Peer-Reviewed Original ResearchUpdated results of a phase I study of Felezonexor (SL-801), a novel XPO-1 reversible inhibitor, in patients with relapsed/refractory solid tumours
Wang J, Barve M, Chiorean E, LoRusso P, Courtney K, Qi D, Bullington J, Sardone M, Chen J, Brooks C, Hoberman M, Mughal T, Bauer T. Updated results of a phase I study of Felezonexor (SL-801), a novel XPO-1 reversible inhibitor, in patients with relapsed/refractory solid tumours. Annals Of Oncology 2020, 31: s485-s486. DOI: 10.1016/j.annonc.2020.08.678.Peer-Reviewed Original ResearchPhase I first-in-human study of ABBV-151 as monotherapy or in combination with budigalimab in patients with locally advanced or metastatic solid tumours
Powderly J, Shimizu T, Lorusso P, Razak A, Miller K, Balar A, Bruix J, Michel L, Blaney M, Guan X, Lacy S, Lally S, Lambert S, Leibman R, Vosganian G, Golan T, Tolcher A. Phase I first-in-human study of ABBV-151 as monotherapy or in combination with budigalimab in patients with locally advanced or metastatic solid tumours. Annals Of Oncology 2020, 31: s499. DOI: 10.1016/j.annonc.2020.08.710.Peer-Reviewed Original ResearchA multicenter, open-label, dose-escalation, first-in-man study of MetAP2 inhibitor M8891 in patients with advanced solid tumours
Carducci M, Wang D, Habermehl C, Bödding M, Rohdich F, Stinchi S, Karpenko O, Gimmi C, LoRusso P. A multicenter, open-label, dose-escalation, first-in-man study of MetAP2 inhibitor M8891 in patients with advanced solid tumours. Annals Of Oncology 2020, 31: s486. DOI: 10.1016/j.annonc.2020.08.680.Peer-Reviewed Original ResearchFirst-in-human study of camidanlumab tesirine (ADCT-301, Cami), an anti-CD25 targeted therapy in patients (pts) with advanced solid tumours: Pharmacokinetics (PK) and biomarker evaluation
Puzanov I, Havenith K, Boni J, Cruz H, Anderson K, Kopotsha T, Le Bruchec Y, Bendell J, Kummar S, Papadopoulos K, LoRusso P, Wuerthner J. First-in-human study of camidanlumab tesirine (ADCT-301, Cami), an anti-CD25 targeted therapy in patients (pts) with advanced solid tumours: Pharmacokinetics (PK) and biomarker evaluation. Annals Of Oncology 2020, 31: s710-s711. DOI: 10.1016/j.annonc.2020.08.1150.Peer-Reviewed Original Research
2018
436P Preliminary results of the first-in-human, dose-finding PROCLAIM-CX-072 trial evaluating the PD-L1 probody therapeutic CX-072 in combination with ipilimumab (ipi) in patients (pts) with advanced solid tumors
Plummer R, Sanborn R, de Vries E, Lorusso P, Arkenau H, Uboha N, Wydmanski J, Fidler M, Boni V, Garcia-Corbacho J, Humphrey R, Will M, Autio K, El-Khoueiry A, van Oordt C, Thistlethwaite F. 436P Preliminary results of the first-in-human, dose-finding PROCLAIM-CX-072 trial evaluating the PD-L1 probody therapeutic CX-072 in combination with ipilimumab (ipi) in patients (pts) with advanced solid tumors. Annals Of Oncology 2018, 29: viii143. DOI: 10.1093/annonc/mdy279.423.Peer-Reviewed Original ResearchPreliminary interim results of the first-in-human, dose-finding PROCLAIM-CX-072 trial of the PD-L1 Probody therapeutic (Pb-Tx) CX-072 in combination with ipilimumab (ipi) in patients (pts) with advanced solid tumors.
Sanborn R, Menke C, Autio K, Arkenau H, Corbacho J, LoRusso P, Plummer E, Uboha N, Freeman M, Wydmanski J, Huels V, Zheng B, Will M, Humphrey R, Thistlethwaite F, de Vries E, El-Khoueiry A. Preliminary interim results of the first-in-human, dose-finding PROCLAIM-CX-072 trial of the PD-L1 Probody therapeutic (Pb-Tx) CX-072 in combination with ipilimumab (ipi) in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2018, 36: 3072-3072. DOI: 10.1200/jco.2018.36.15_suppl.3072.Peer-Reviewed Original ResearchA phase 1 study of MDM2 inhibitor DS-3032b in patients with well/de-differentiated liposarcoma (WD/DD LPS), solid tumors (ST) and lymphomas (L).
Bauer T, Gounder M, Weise A, Schwartz G, Carvajal R, Kumar P, Zernovak O, Beck A, Doyle J, Mendell-Harary J, Kochan J, Chen S, LoRusso P, Tap W, Somaiah N, Hyman D, Meric-Bernstam F, Hong D. A phase 1 study of MDM2 inhibitor DS-3032b in patients with well/de-differentiated liposarcoma (WD/DD LPS), solid tumors (ST) and lymphomas (L). Journal Of Clinical Oncology 2018, 36: 11514-11514. DOI: 10.1200/jco.2018.36.15_suppl.11514.Peer-Reviewed Original ResearchResults of the first-in-human study of ABBV-075 (mivebresib), a pan-inhibitor of bromodomain (BD) and extra terminal (BET) proteins, in patients (pts) with relapsed/refractory (R/R) solid tumors.
Piha-Paul S, Sachdev J, Barve M, LoRusso P, Szmulewitz R, Patel S, McKee M, Wolff J, Hu B, Sood A, Chen X, Wilson S, O'Neil B. Results of the first-in-human study of ABBV-075 (mivebresib), a pan-inhibitor of bromodomain (BD) and extra terminal (BET) proteins, in patients (pts) with relapsed/refractory (R/R) solid tumors. Journal Of Clinical Oncology 2018, 36: 2510-2510. DOI: 10.1200/jco.2018.36.15_suppl.2510.Peer-Reviewed Original Research