2025
The first-in-human phase 1/2 study of TSN1611, a highly selective KRAS G12D inhibitor, in patients with advanced solid tumors.
Fu S, Shen L, Lu S, Sommerhalder D, Liu T, Spira A, Li J, Yu Y, Li W, Li J, Song B, Dong C, Lai L, Ma S, Shang E, Zhong B, Zhang T. The first-in-human phase 1/2 study of TSN1611, a highly selective KRAS G12D inhibitor, in patients with advanced solid tumors. Journal Of Clinical Oncology 2025, 43: 3083-3083. DOI: 10.1200/jco.2025.43.16_suppl.3083.Peer-Reviewed Original ResearchMaximum tolerated doseNon-small cell lung cancer modelTreatment related adverse eventsPancreatic ductal carcinomaColorectal cancerSolid tumorsFirst-in-human phase 1/2 studyRecommended phase 2 doseTumor cells in vitroMedian prior linesPhase 1/2 studyPhase 1b/2 studyPhase 2 dosePhase 2 partRelated grade 3Dose-limiting toxicityAdvanced solid tumorsDose-escalation partEvaluated dose rangeNausea and diarrheaInhibited tumor growthLung cancer modelRelated adverse eventsStandard of careCells in vitroAn all-oral regimen of decitabine-cedazuridine (DEC-C) plus venetoclax (VEN) in patients (pts) with newly diagnosed acute myeloid leukemia (AML) ineligible for intensive induction chemotherapy: Results from a phase 2 cohort of 101 pts.
Zeidan A, Griffiths E, Dinardo C, Mannis G, Montesinos P, Arnan M, Savona M, Odenike O, McCloskey J, Amin H, Fathi A, Bernal del Castillo T, Rodriguez-Macias G, Liesveld J, Im A, Oganesian A, Xu Q, Dijkstra M, Keer H, Roboz G. An all-oral regimen of decitabine-cedazuridine (DEC-C) plus venetoclax (VEN) in patients (pts) with newly diagnosed acute myeloid leukemia (AML) ineligible for intensive induction chemotherapy: Results from a phase 2 cohort of 101 pts. Journal Of Clinical Oncology 2025, 43: 6504-6504. DOI: 10.1200/jco.2025.43.16_suppl.6504.Peer-Reviewed Original ResearchAcute myeloid leukemiaAll-oral regimenInduction chemotherapyEuropean LeukemiaNetCR rateMedian time to CRTreatment-emergent adverse eventsBCL-2 inhibitor venetoclaxDiagnosed AMLDiagnosed acute myeloid leukemiaMedian CR durationPhase 2 partAll-oral regimensIntensive induction chemotherapyPhase 1/2 trialBone marrow examinationMedian follow-upTime to CRConfidence intervalsDrug-drug interactionsPhase 2 cohortIntravenous decitabineMedian OSCR durationFebrile neutropenia
2021
IMerge: A phase 3 study to evaluate imetelstat in transfusion-dependent subjects with IPSS low or intermediate-1 risk myelodysplastic syndromes that are relapsed/refractory to erythropoiesis-stimulating agent treatment.
Platzbecker U, Komrokji R, Fenaux P, Zeidan A, Sekeres M, Savona M, Madanat Y, Sherman L, Dougherty S, Sun L, Huang F, Wan Y, Rizo A, Berry T, Feller F, Santini V. IMerge: A phase 3 study to evaluate imetelstat in transfusion-dependent subjects with IPSS low or intermediate-1 risk myelodysplastic syndromes that are relapsed/refractory to erythropoiesis-stimulating agent treatment. Journal Of Clinical Oncology 2021, 39: tps7056-tps7056. DOI: 10.1200/jco.2021.39.15_suppl.tps7056.Peer-Reviewed Original ResearchInternational Prognostic Scoring SystemErythropoiesis-stimulating agentsPhase 3 partRisk myelodysplastic syndromesMyelodysplastic syndromeRBC-TIRed blood cell (RBC) transfusion-dependent patientsErythropoiesis-stimulating agent treatmentLower-risk myelodysplastic syndromesPhase 2 partProgression of MDSRBC transfusion independenceTransfusion dependent subjectsPlacebo-controlled trialPhase 2/3 studyPhase 3 studyPrognostic scoring systemCurrent treatment optionsTransfusion-dependent patientsQuality of lifeMedian TI durationRate of CRVariant allele frequencyMechanism of actionAdult pts
2019
Guadecitabine (SGI-110) in patients with intermediate or high-risk myelodysplastic syndromes: phase 2 results from a multicentre, open-label, randomised, phase 1/2 trial
Garcia-Manero G, Roboz G, Walsh K, Kantarjian H, Ritchie E, Kropf P, O'Connell C, Tibes R, Lunin S, Rosenblat T, Yee K, Stock W, Griffiths E, Mace J, Podoltsev N, Berdeja J, Jabbour E, Issa JJ, Hao Y, Keer HN, Azab M, Savona MR. Guadecitabine (SGI-110) in patients with intermediate or high-risk myelodysplastic syndromes: phase 2 results from a multicentre, open-label, randomised, phase 1/2 trial. The Lancet Haematology 2019, 6: e317-e327. PMID: 31060979, PMCID: PMC9012213, DOI: 10.1016/s2352-3026(19)30029-8.Peer-Reviewed Original ResearchConceptsHigh-risk myelodysplastic syndromeMyelodysplastic syndromeRefractory cohortAdverse eventsRefractory diseaseHypomethylating agentEastern Cooperative Oncology Group performance statusNorth American medical centersInternational Prognostic Scoring SystemCommon grade 3Phase 2 partWorse adverse eventsOpen-label studyProportion of patientsPrognostic scoring systemOverall responseChronic myelomonocytic leukemiaNew therapeutic optionsAmerican medical centersEligible patientsFebrile neutropaeniaIntravenous decitabinePrimary endpointRefractory patientsStudy drug
2015
Phase 1/2 trial of cabazitaxel with abiraterone acetate in patients with metastatic castration-resistant prostate cancer (mCRPC) progressing after docetaxel and abiraterone acetate: Phase 2 results.
Mateo J, Fizazi K, Pezaro C, Loriot Y, Mehra N, Albiges L, Bianchini D, Varga A, Ryan C, Petrylak D, Shen L, Zhang J, Attard G, De Bono J, Massard C. Phase 1/2 trial of cabazitaxel with abiraterone acetate in patients with metastatic castration-resistant prostate cancer (mCRPC) progressing after docetaxel and abiraterone acetate: Phase 2 results. Journal Of Clinical Oncology 2015, 33: 268-268. DOI: 10.1200/jco.2015.33.7_suppl.268.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerPhase 2 partProgression-free survivalAbiraterone acetateAdverse eventsPrimary endpointTreatment-emergent adverse eventsCastration-resistant prostate cancerECOG PS 0Median PSA-PFSPSA response rateAntitumor activityOpen-label trialDuration of responseCombination of abirateroneMeasurable diseasePSA-PFSRECIST 1.1Secondary endpointsDose intensityOverall survivalPartial responsePS 0PSA responseMedian time
2014
1473P Phase 1B Trial of Anti-Notch 2/3 Antibody Omp-59R5 in Combination with Etoposide and Cisplatin (Ep) in Patients (Pts) with Untreated Extensive-Stage Small-Cell Lung Cancer (Ed-Sclc): the Pinnacle Study
Pietanza M, Spira A, Jotte R, Gadgeel S, Mita A, Liu S, Gluck W, Kalemkerian G, Chiang A, Hart L, Kapoun A, Xu L, Hill D, Zhou L, Dupont J, Spigel D. 1473P Phase 1B Trial of Anti-Notch 2/3 Antibody Omp-59R5 in Combination with Etoposide and Cisplatin (Ep) in Patients (Pts) with Untreated Extensive-Stage Small-Cell Lung Cancer (Ed-Sclc): the Pinnacle Study. Annals Of Oncology 2014, 25: iv514. DOI: 10.1093/annonc/mdu355.11.Peer-Reviewed Original ResearchDose-limiting toxicityAnti-tumor activityDay 1Untreated extensive stage small cell lung cancerExtensive-stage small-cell lung cancerMain dose-limiting toxicitySmall cell lung cancerGrade 3 diarrheaGrade 3 nauseaPhase 2 partPhase 1b trialPK/pharmacodynamicsED-SCLCSCLC xenograftsDose cohortsRECIST 1.1Peripheral edemaUnacceptable toxicityAdverse eventsSupportive carePreliminary efficacyLung cancerDisease progressionEfficacy dataIgG2 antibodies
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