2024
A phase Ib/II study of an anti-CD137 agonist antibody ADG106 in combination with weekly paclitaxel and dose-dense doxorubicin/cyclophosphamide.
Lee M, Ow S, Wong A, Lim S, Lim J, Soo R, Cheng Ean C, Tan D, Yong W, Chan G, Ho J, Sooi K, Low Q, Ang C, Cheo S, Sundar R, Goh B, Lee S. A phase Ib/II study of an anti-CD137 agonist antibody ADG106 in combination with weekly paclitaxel and dose-dense doxorubicin/cyclophosphamide. Journal Of Clinical Oncology 2024, 42: e14507-e14507. DOI: 10.1200/jco.2024.42.16_suppl.e14507.Peer-Reviewed Original ResearchAdverse eventsG3 neutropeniaTumor biopsiesWeekly PPeripheral neuropathyHER2 negative breast cancer patientsPhase IbDose levelsRecommended phase 2 doseAll-grade adverse eventsNegative breast cancer patientsMatched tumor biopsiesPhase 2 doseTumor immune markersPneumocystis jiroveci pneumoniaAdvanced solid tumorsPalliative systemic therapyPhase Ib trialPhase II trialPhase IISerial tumor biopsiesBreast cancer patientsIgG4 monoclonal antibodyAcneiform rashAnti-CD137Abstract CT160: A phase I trial to evaluate allogeneic NKG2DL-targeting chimeric antigen receptor-grafted γδ T cells in subjects with advanced solid tumors or hematological malignancies (the ANGELICA Trial)
Choo J, Tan W, Luk L, Zeng J, Soh T, Soon S, Lieow J, Wong C, Pang M, Bari S, Poon M, Koh L, Chng W, Jeyasekharan A, Tan L, Chan E, Sundar R. Abstract CT160: A phase I trial to evaluate allogeneic NKG2DL-targeting chimeric antigen receptor-grafted γδ T cells in subjects with advanced solid tumors or hematological malignancies (the ANGELICA Trial). Cancer Research 2024, 84: ct160-ct160. DOI: 10.1158/1538-7445.am2024-ct160.Peer-Reviewed Original ResearchAdoptive cellular therapyPhase I studyHematologic malignanciesSolid tumorsCellular infusionT cellsHealthy donorsAmerican Association for Cancer Research annual meetingsDose levelsRecommended phase 2 doseTreatment of hematological malignanciesPhase 2 dosePoor marrow functionSubcutaneous IL-2Treatment-refractory tumorsDose-limiting toxicityPeripheral blood mononuclear cellsPre-treated patientsT-cell therapyPre-clinical dataBlood mononuclear cellsT cell survivalEnrollment of patientsDiverse tissue originDose escalation
2022
A phase 1 study of the safety, pharmacokinetics and pharmacodynamics of escalating doses followed by dose expansion of the selective inhibitor of nuclear export (SINE) selinexor in Asian patients with advanced or metastatic malignancies
Ho J, Heong V, Yong W, Soo R, Chee C, Wong A, Sundar R, Thian Y, Gopinathan A, Pang M, Koe P, Jeraj S, Soe P, Soe M, Tang T, Ng M, Tai D, Tan T, Xu H, Chang H, Landesman Y, Shah J, Shacham S, Lee S, Tan D, Goh B, Tan D. A phase 1 study of the safety, pharmacokinetics and pharmacodynamics of escalating doses followed by dose expansion of the selective inhibitor of nuclear export (SINE) selinexor in Asian patients with advanced or metastatic malignancies. Therapeutic Advances In Medical Oncology 2022, 14: 17588359221087555. PMID: 35432603, PMCID: PMC9008867, DOI: 10.1177/17588359221087555.Peer-Reviewed Original ResearchPhase 1 studyAsian patientsMetastatic malignancyMedian t<sub>max</sub> wasGrade 3 adverse eventsNCI Common Terminology CriteriaRecommended phase 2 doseAsian patient cohortContinuous dosing regimensGrade 3 fatiguePhase 2 doseThymic carcinoma patientsDose-escalation designCommon Terminology CriteriaInhibitor of nuclear exportCytoplasmic localization of p27Dose expansionComplete responseHodgkin lymphomaExpansion cohortLymphoma patientsPartial responseDrug holidayEscalation designPharmacodynamic assessments
2020
Clinical efficacy and molecular effects of lenvatinib (Len) and letrozole (Let) in hormone receptor-positive (HR+) metastatic breast cancer (MBC).
Lim J, Wong A, Ow S, Ngoi N, Ang Y, Chan G, Eng L, Chong W, Choo J, Lee M, Tan H, Jan Y, Tan K, Sundar R, Tan D, Soo R, Chee C, Yong W, Goh B, Lee S. Clinical efficacy and molecular effects of lenvatinib (Len) and letrozole (Let) in hormone receptor-positive (HR+) metastatic breast cancer (MBC). Journal Of Clinical Oncology 2020, 38: 1019-1019. DOI: 10.1200/jco.2020.38.15_suppl.1019.Peer-Reviewed Original ResearchDisease control rateObjective response rateMetastatic breast cancerEffect of lenvatinibDose escalationEndocrine therapyEfficacy dataRecommended phase 2 doseAll-grade toxicitiesPhase 2 doseDose-escalation phaseHormone receptor-positiveDuration of responsePhase Ib/II studyTumor molecular profilingSerial tumor biopsiesAnti-tumor activityMolecular effectsMedian DoRPrior CTPALB2 mutationsProgression-freeExpansion cohortMBC patientsReceptor-positiveSafety and tolerability of oxaliplatin based pressurized intraperitoneal aerosol chemotherapy (PIPAC) for patients with peritoneal carcinomatosis: A phase I dose-finding study in Asian patients.
Sundar R, Kim G, Tan H, Wang L, Chue K, Tai C, Teo S, Jang C, Chee C, Lieske B, Chee C, Shabbir A, So J, Yong W. Safety and tolerability of oxaliplatin based pressurized intraperitoneal aerosol chemotherapy (PIPAC) for patients with peritoneal carcinomatosis: A phase I dose-finding study in Asian patients. Journal Of Clinical Oncology 2020, 38: 360-360. DOI: 10.1200/jco.2020.38.4_suppl.360.Peer-Reviewed Original ResearchPressurized intraperitoneal aerosol chemotherapyPeritoneal carcinomatosis indexDose-limiting toxicityHyperthermic intraperitoneal chemotherapyPhase 1 studyDose cohortsAsian patientsDose-escalation phase 1 studyPIPAC administrationsGrade 3 adverse eventsMedian peritoneal carcinomatosis indexPeritoneal carcinomatosis index scoreRecommended phase 2 dosePressurized intraperitoneal aerosolized chemotherapy proceduresFailure of standard therapyPhase I dose-finding studyGastrointestinal primary tumorsHighest dose cohortPhase 2 doseDose-escalation studyIntraperitoneal chemotherapyPeritoneal carcinomatosisEscalation studyPeritoneal metastasisOxaliplatin chemotherapy
2019
A phase Ib/II trial of lenvatinib (len) and letrozole (let) incorporating pharmacodynamics studies in postmenopausal women with hormone receptor positive (HR+) locally advanced/metastatic breast cancer (LABC/MBC).
Lim J, Wong A, Ow S, Eng L, Sundar R, Chan G, Yadav K, Heong V, Tan D, Soo R, Chee C, Yong W, Goh B, Lee S. A phase Ib/II trial of lenvatinib (len) and letrozole (let) incorporating pharmacodynamics studies in postmenopausal women with hormone receptor positive (HR+) locally advanced/metastatic breast cancer (LABC/MBC). Journal Of Clinical Oncology 2019, 37: 1045-1045. DOI: 10.1200/jco.2019.37.15_suppl.1045.Peer-Reviewed Original ResearchDose-limiting toxicityDisease control ratePalmar-plantar erythrodysesthesiaDose reductionBreast cancerDose levelsMechanisms of endocrine resistanceRecommended phase 2 dosePhase 2 doseAdvanced/metastatic breast cancerHR+ breast cancerPhase Ib trialContinuous daily dosingSerial tumor biopsiesAnti-tumor activityStandard of careDose expansionG3 toxicityPrior CTPostmenopausal womenTumor biopsiesEndocrine resistanceDaily doseEstrogen receptorPreclinical studies
2018
A phase I/Ib study of OTSGC-A24 combined peptide vaccine in advanced gastric cancer
Sundar R, Rha S, Yamaue H, Katsuda M, Kono K, Kim H, Kim C, Mimura K, Kua L, Yong W. A phase I/Ib study of OTSGC-A24 combined peptide vaccine in advanced gastric cancer. BMC Cancer 2018, 18: 332. PMID: 29587677, PMCID: PMC5870101, DOI: 10.1186/s12885-018-4234-8.Peer-Reviewed Original ResearchConceptsAdvanced gastric cancerCytotoxic T lymphocytesGastric cancerCancer vaccinesOverall survivalAdverse eventsRecommended phase 2 doseMedian progression free survivalSpecific cytotoxic T lymphocytesTreatment-related adverse eventsAdvanced gastric cancer patientsPeptide cancer vaccinesPhase 2 dosePhase I/Ib studyPositive CTL responsesDose-limiting toxicityMedian overall survivalProgression free survivalInjection site erythemaOptimal dosing scheduleGastric cancer patientsSingle-arm trialPhase I/IbStable diseaseFree survival
2017
TAX-TORC: A phase I trial of vistusertib (AZD2014) in combination with weekly paclitaxel with integrated pharmacodynamic (PD) and molecular characterization (MC) studies.
Sundar R, Basu B, Wilson R, Spicer J, Jones R, Krebs M, Brada M, Talbot D, Steele N, Hall E, Tovey H, Carreira S, de Oliveira F, Swales K, Balarajah G, Dawes J, Parmar M, De Bono J, Banerji U. TAX-TORC: A phase I trial of vistusertib (AZD2014) in combination with weekly paclitaxel with integrated pharmacodynamic (PD) and molecular characterization (MC) studies. Journal Of Clinical Oncology 2017, 35: 2571-2571. DOI: 10.1200/jco.2017.35.15_suppl.2571.Peer-Reviewed Original ResearchHigh-grade serous ovarian cancerHigh-grade serous ovarian cancer patientsRecommended phase 2 doseMedian progression free survivalImproving outcomes of patientsPhase 2 doseDose-limiting toxicityDose-escalation partProgression free survivalArchival tumor tissuePhase I trialSerous ovarian cancerOutcomes of patientsLines of treatmentResistance to chemotherapyP-S6K levelsPre-dose levelsPlatelet-rich plasmaWeekly paclitaxelExpansion cohortFree survivalPlatinum therapyATM mutationsLimiting toxicitiesBID PODose-exposure-response relationship between AZD6738 and peripheral monocytes.
Pierce A, Berges A, Cheung S, Standifer N, Ross G, Smith S, Hollingsworth S, Krebs M, Postel-Vinay S, Bang Y, El-Khoueiry A, Abida W, Sundar R, Carter L, Castanon-Alvarez E, Im S, Lopez J, Yap T, Harrington K, Soria J. Dose-exposure-response relationship between AZD6738 and peripheral monocytes. Journal Of Clinical Oncology 2017, 35: e14063-e14063. DOI: 10.1200/jco.2017.35.15_suppl.e14063.Peer-Reviewed Original ResearchDose-exposure-response relationshipPeripheral monocytesPARP-1 inhibitor olaparibPD-L1 inhibitor durvalumabPeripheral blood cell subpopulationsPhase 2 doseFlow cytometry characterizationPARP-1Dose-dependent mannerBlood cell subpopulationsPhosphatidylinositol 3-kinase-related kinasesPD-L1Peripheral pharmacokineticsInhibitor olaparibPeripheral bloodDrug exposureBone marrowPharmacodynamic effectsPharmacokinetic/pharmacodynamic relationshipsSurrogate markerClinical studiesMonocyte countMonocyte levelsPrecursor proliferationDurvalumab