James Cleary, MD, PhD

Hale Clinical Investigator

Department of Medical Oncology, Dana-Farber Cancer Institute

Assistant Professor of Medicine, Harvard Medical School

 

 

 

Bio       Research interests      Key publications

Bio

Dr. Cleary is a medical oncologist at the Dana-Farber Cancer Institute who specializes in treating gastrointestinal cancers. He was awarded a Lustgarten/SU2C Grant that is supporting his work developing new therapies for patients with pancreatic cancer. Dr. Cleary has over 30 publications in such journals as The New England Journal of Medicine, The Lancet, Journal of Clinical Oncology, Cancer Discovery, and Journal of Clinical Investigation. In addition to his research activities, he was won awards for his clinical care at Dana-Farber and his teaching at Harvard Medical School.

Research interests

As the Associate Director of Clinical Research of the Gastrointestinal Cancer Center at Dana-Farber Cancer Institute (DFCI) and clinical liaison for gastrointestinal malignancies for both the DFCI Early Drug Development Center and the DFCI Center for Immunotherapy, Dr. Cleary has developed extensive experience leading clinical trials. A major focus of Dr. Cleary’s research is developing therapies that exploit double-strand DNA damage repair (DDR) deficiency in metastatic pancreatic adenocarcinoma. He currently is leading a phase 2 clinical trial of the niraparib PARP inhibitor in pancreatic cancer patients with DNA repair deficiencies. Along with Dr. Alan D’Andrea, he is the co-leader of a Stand Up to Cancer(SU2C)/ Lustgarten grant that is evaluating DNA repair inhibitors in pancreatic cancer organoids and patient-derived xenograft (PDX) models. The goal of this grant is to utilize these preclinical studies to identify the most potent combinatorial strategy, along with predictive biomarkers, that will inform the design of clinical trial for pancreatic cancer patients.

Key publications

Voss MH, Hierro C, Heist RS, Cleary JM, Meric-Bernstam F, Tabernero J, Janku F, Gandhi L, Iafrate AJ, Borger DR, Ishii N, Hu Y, Kirpicheva Y, Nicolas-Metral V, Pokorska-Bocci A, Vaslin Chessex A, Zanna C, Flaherty KT, Baselga J. A Phase I, Open-Label, Multicenter, Dose-escalation Study of the Oral Selective FGFR Inhibitor Debio 1347 in Patients with Advanced Solid Tumors Harboring FGFR Gene Alterations. Clin Cancer Res. 2019;25(9):2699-707. Epub 2019/02/13. doi: 10.1158/1078-0432.CCR-18-1959. PubMed PMID: 30745300.
 
Shapiro GI, LoRusso P, Kwak E, Pandya S, Rudin CM, Kurkjian C, Cleary JM, Pilat MJ, Jones S, de Crespigny A, Fredrickson J, Musib L, Yan Y, Wongchenko M, Hsieh HJ, Gates MR, Chan IT, Bendell J. Phase Ib study of the MEK inhibitor cobimetinib (GDC-0973) in combination with the PI3K inhibitor pictilisib (GDC-0941) in patients with advanced solid tumors. Invest New Drugs. 2019. Epub 2019/04/26. doi: 10.1007/s10637-019-00776-6. PubMed PMID: 31020608.
 
Ng K, Nimeiri HS, McCleary NJ, Abrams TA, Yurgelun MB, Cleary JM, Rubinson DA, Schrag D, Miksad R, Bullock AJ, Allen J, Zuckerman D, Chan E, Chan JA, Wolpin BM, Constantine M, Weckstein DJ, Faggen MA, Thomas CA, Kournioti C, Yuan C, Ganser C, Wilkinson B, Mackintosh C, Zheng H, Hollis BW, Meyerhardt JA, Fuchs CS. Effect of High-Dose vs Standard-Dose Vitamin D3 Supplementation on Progression-Free Survival Among Patients With Advanced or Metastatic Colorectal Cancer: The SUNSHINE Randomized Clinical Trial. JAMA. 2019;321(14):1370-9. Epub 2019/04/10. doi: 10.1001/jama.2019.2402. PubMed PMID: 30964527; PMCID: PMC6459117.
 
Lowery MA, Burris HA, 3rd, Janku F, Shroff RT, Cleary JM, Azad NS, Goyal L, Maher EA, Gore L, Hollebecque A, Beeram M, Trent JC, Jiang L, Fan B, Aguado-Fraile E, Choe S, Wu B, Gliser C, Agresta SV, Pandya SS, Zhu AX, Abou-Alfa GK. Safety and activity of ivosidenib in patients with IDH1-mutant advanced cholangiocarcinoma: a phase 1 study. Lancet Gastroenterol Hepatol. 2019. Epub 2019/07/14. doi: 10.1016/S2468-1253(19)30189-X. PubMed PMID: 31300360.
 
Cleary JM, Horick NK, McCleary NJ, Abrams TA, Yurgelun MB, Azzoli CG, Rubinson DA, Brooks GA, Chan JA, Blaszkowsky LS, Clark JW, Goyal L, Meyerhardt JA, Ng K, Schrag D, Savarese DMF, Graham C, Fitzpatrick B, Gibb KA, Boucher Y, Duda DG, Jain RK, Fuchs CS, Enzinger PC. FOLFOX plus ziv-aflibercept or placebo in first-line metastatic esophagogastric adenocarcinoma: A double-blind, randomized, multicenter phase 2 trial. Cancer. 2019. Epub 2019/03/27. doi: 10.1002/cncr.32029. PubMed PMID: 30913304.
 
Bekaii-Saab TS, Ou FS, Ahn DH, Boland PM, Ciombor KK, Heying EN, Dockter TJ, Jacobs NL, Pasche BC, Cleary JM, Meyers JP, Desnoyers RJ, McCune JS, Pedersen K, Barzi A, Chiorean EG, Sloan J, Lacouture ME, Lenz HJ, Grothey A. Regorafenib dose-optimisation in patients with refractory metastatic colorectal cancer (ReDOS): a randomised, multicentre, open-label, phase 2 study. Lancet Oncol. 2019. Epub 2019/07/03. doi: 10.1016/S1470-2045(19)30272-4. PubMed PMID: 31262657.

Jenkins RW, Aref AR, Lizotte PH, Ivanova E, Stinson S, Zhou CW, Bowden M, Deng J, Liu H, Miao D, He MX, Walker W, Zhang G, Tian T, Cheng C, Wei Z, Palakurthi S, Bittinger M, Vitzthum H, Kim JW, Merlino A, Quinn M, Venkataramani C, Kaplan JA, Portell A, Gokhale PC, Phillips B, Smart A, Rotem A, Jones RE, Keogh L, Anguiano M, Stapleton L, Jia Z, Barzily-Rokni M, Canadas I, Thai TC, Hammond MR, Vlahos R, Wang ES, Zhang H, Li S, Hanna GJ, Huang W, Hoang MP, Piris A, Eliane JP, Stemmer-Rachamimov AO, Cameron L, Su MJ, Shah P, Izar B, Thakuria M, LeBoeuf NR, Rabinowits G, Gunda V, Parangi S, Cleary JM, Miller BC, Kitajima S, Thummalapalli R, Miao B, Barbie TU, Sivathanu V, Wong J, Richards WG, Bueno R, Yoon CH, Miret J, Herlyn M, Garraway LA, Van Allen EM, Freeman GJ, Kirschmeier PT, Lorch JH, Ott PA, Hodi FS, Flaherty KT, Kamm RD, Boland GM, Wong KK, Dornan D, Paweletz CP, Barbie DA. Ex Vivo Profiling of PD-1 Blockade Using Organotypic Tumor Spheroids. Cancer Discov. 2018;8(2):196-215. Epub 2017/11/05. doi: 10.1158/2159-8290.CD-17-0833. PubMed PMID: 29101162; PMCID: PMC5809290.
 
Aguirre AJ, Nowak JA, Camarda ND, Moffitt RA, Ghazani AA, Hazar-Rethinam M, Raghavan S, Kim J, Brais LK, Ragon D, Welch MW, Reilly E, McCabe D, Marini L, Anderka K, Helvie K, Oliver N, Babic A, Da Silva A, Nadres B, Van Seventer EE, Shahzade HA, St Pierre JP, Burke KP, Clancy T, Cleary JM, Doyle LA, Jajoo K, McCleary NJ, Meyerhardt JA, Murphy JE, Ng K, Patel AK, Perez K, Rosenthal MH, Rubinson DA, Ryou M, Shapiro GI, Sicinska E, Silverman SG, Nagy RJ, Lanman RB, Knoerzer D, Welsch DJ, Yurgelun MB, Fuchs CS, Garraway LA, Getz G, Hornick JL, Johnson BE, Kulke MH, Mayer RJ, Miller JW, Shyn PB, Tuveson DA, Wagle N, Yeh JJ, Hahn WC, Corcoran RB, Carter SL, Wolpin BM. Real-time Genomic Characterization of Advanced Pancreatic Cancer to Enable Precision Medicine. Cancer Discov. 2018;8(9):1096-111. Epub 2018/06/16. doi: 10.1158/2159-8290.CD-18-0275. PubMed PMID: 29903880; PMCID: PMC6192263.
 
Viswanathan VS, Ryan MJ, Dhruv HD, Gill S, Eichhoff OM, Seashore-Ludlow B, Kaffenberger SD, Eaton JK, Shimada K, Aguirre AJ, Viswanathan SR, Chattopadhyay S, Tamayo P, Yang WS, Rees MG, Chen S, Boskovic ZV, Javaid S, Huang C, Wu X, Tseng YY, Roider EM, Gao D, Cleary JM, Wolpin BM, Mesirov JP, Haber DA, Engelman JA, Boehm JS, Kotz JD, Hon CS, Chen Y, Hahn WC, Levesque MP, Doench JG, Berens ME, Shamji AF, Clemons PA, Stockwell BR, Schreiber SL. Dependency of a therapy-resistant state of cancer cells on a lipid peroxidase pathway. Nature. 2017;547(7664):453-7. Epub 2017/07/06. doi: 10.1038/nature23007. PubMed PMID: 28678785; PMCID: PMC5667900.
 
Mita MM, Mita AC, Moseley JL, Poon J, Small KA, Jou YM, Kirschmeier P, Zhang D, Zhu Y, Statkevich P, Sankhala KK, Sarantopoulos J, Cleary JM, Chirieac LR, Rodig SJ, Bannerji R, Shapiro GI. Phase 1 safety, pharmacokinetic and pharmacodynamic study of the cyclin-dependent kinase inhibitor dinaciclib administered every three weeks in patients with advanced malignancies. Br J Cancer. 2017;117(9):1258-68. Epub 2017/09/01. doi: 10.1038/bjc.2017.288. PubMed PMID: 28859059; PMCID: PMC5672931.
 
Goyal L, Zheng H, Yurgelun MB, Abrams TA, Allen JN, Cleary JM, Knowles M, Regan E, Reardon A, Khachatryan A, Jain RK, Nardi V, Borger DR, Duda DG, Zhu AX. A phase 2 and biomarker study of cabozantinib in patients with advanced cholangiocarcinoma. Cancer. 2017;123(11):1979-88. Epub 2017/02/14. doi: 10.1002/cncr.30571. PubMed PMID: 28192597; PMCID: PMC5444988.
 
Cleary JM, Rosen LS, Yoshida K, Rasco D, Shapiro GI, Sun W. A phase 1 study of the pharmacokinetics of nucleoside analog trifluridine and thymidine phosphorylase inhibitor tipiracil (components of TAS-102) vs trifluridine alone. Invest New Drugs. 2017;35(2):189-97. Epub 2017/01/24. doi: 10.1007/s10637-016-0409-9. PubMed PMID: 28111727; PMCID: PMC5352756.
 

Cleary JM, McRee AJ, Shapiro GI, Tolaney SM, O’Neil BH, Kearns JD, Mathews S, Nering R, MacBeath G, Czibere A, Sharma S, Korn WM. A phase 1 study combining the HER3 antibody seribantumab (MM-121) and cetuximab with and without irinotecan. Invest New Drugs. 2017;35(1):68-78. Epub 2016/11/18. doi: 10.1007/s10637-016-0399-7. PubMed PMID: 27853996.
 
Abramson VG, Supko JG, Ballinger T, Cleary JM, Hilton JF, Tolaney SM, Chau NG, Cho DC, Pearlberg J, Lager J, Shapiro GI, Arteaga CL. Phase Ib Study of Safety and Pharmacokinetics of the PI3K Inhibitor SAR245408 with the HER3-Neutralizing Human Antibody SAR256212 in Patients with Solid Tumors. Clin Cancer Res. 2017;23(14):3520-8. Epub 2016/12/30. doi: 10.1158/1078-0432.CCR-16-1764. PubMed PMID: 28031425.
 

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