Phase 1 Program

Contact Us

Phone: 206.606.7551
Email: phase1clinicaltrial@fredhutch.org
Fax: 206.606.6681

Mailing Address

825 Eastlake Ave. E.
Mailstop CE2-102
Seattle, WA  998109-1023

Fred Hutchinson Cancer Center treats each patient with the best care possible. Sometimes, that involves a clinical trial. 

Our Phase 1 clinical trials offer an option to people with advanced cancer when conventional treatments no longer work. These trials, which study innovative new therapies in people for the first time, are critical to future patients, who may benefit from today’s breakthroughs, and to the health care industry, which is searching for tomorrow’s cures.

Leading researchers and cancer experts from Fred Hutch and the UW Medicine partner as one team devoted to your best possible outcome.

Mission Statement

The Phase 1 Program partners with patients and families to conduct-cutting edge cancer research for the advancement of science. Our clinical trial expertise allows us to inspire hope and provide compassionate care for those who face a lack of treatment options. We collaborate with our Cancer Consortium and leading industry partners to improve quality care for current and future generations.

Phase 1 Program Capabilities

Fred Hutch provides the first academic-based Phase 1 program for cancer research in the Pacific Northwest. 

Phase I clinical trials require a high level of technical and scientific competencies, like those found at Fred Hutch. Our program provides unique opportunities for correlative studies that take advantage of our consortium’s research strengths, such as world-class positron emission tomography (PET) imaging, proteomics, biomarkers and genomics cores.

Research Services We Provide

The Phase 1 Program provides a full range of research services to advance the development, implementation and successful completion of clinical trials.

  • The test agents that we study include immune-modifying agents such as antibodies to immune checkpoints, small molecules that target cancer-causing mutations, antibody/drug conjugates, agents that target the immune microenvironment and vasculature, and other targets. We partner with pharmaceutical companies to move promising agents from pre-clinical development to early-phase trials in patients with cancer. 
  • Regulatory review (such as for the safety of study participants) includes scientific committee review, radiation safety review and institutional review board (IRB) review.
  • We have experience conducting outpatient trials at Fred Hutch - South Lake Union and inpatient trials at UW Medical Center - Montlake.

Clinical Trials Unit

We created our Clinical Trials Unit with the highest level of quality and comfort for our patients. Features include:

  • A lounge with comfortable chairs, a flat-panel television and snacks to create a peaceful environment.
  • Four patient rooms where each patient can receive care in one place, with nursing staff and research coordinators close by.

The Clinical Trials Unit is open from Monday through Friday, 8 am to 10 pm. If an overnight stay is required, our patients stay at UW Medical Center - Montlake.

Phase 1 Program Team

Our highly skilled and devoted staff, nurses and physicians have extensive research experience and provide the exacting care and attention required to test potential breakthrough therapies.

John A. Thompson, MD

John A. Thompson, MD

Director, Phase 1 Clinical Trials Program, Fred Hutch
Member, Clincial Research Division, Fred Hutch
Professor, Medical Oncology Division, University of Washington
Bojana I. Askovich, PhD

Bojana I. Askovich, PhD

Phase 1, Program Administrator, Fred Hutch
Principal Research Scientist, Fred Hutch
  • Hannah Lee, CCRC, Senior Research Manager
  • Harini Ramachandran, Principal Research Coordinator
  • Olga Tsvetkova, Senior Research Coordinator
  • Elizabeth Liu, Research Coordinator
  • Catherine Ashley, Research Coordinator
  • Chi Westerhold, Senior Research Coordinator
  • LyTieng Huot, Research Coordinator
  • Amanda Ramsing-Lund, Research Coordinator
  • Audrey McCarthy, Research Coordinator
  • Morgan Kauss, Research Coordinator
  • Alise Quynh-Huong Vu, Research Coordinator
  • Fanqi Shi, Research Coordinator
  • Danika Anderson, Research Coordinator
  • Jeniece Hensel, CCRP, Senior Research Data Manager
  • Meghan Laurie, CCRP, Assistant Data Manager
  • Alice Tran, Senior Data Coordinator
  • Ella Hileman-Kaplan, Data Coordinator
  • Megan Omoto, Data Coordinator
  • Sophia Gould, Data Coordinator
  • Caroline McKewan, Data Coordinator
  • Sydney Burns, Research Study Assistant
  • Meagan Tumy, Student Assistant
  • Reina Hibbert, CCRC, Principal Regulatory Affairs Manager
  • Patrick Toler, Principal Regulatory Affairs Coordinator
  • Jordan Cooper, Senior Regulatory Affairs Coordinator 
  • Sarah Beasley, Regulatory Coordinator
  • Sarah Lampert, Regulatory Coordinator
  • Rajee Pandey, Regulatory Research Assistant
  • Emily Basom, Student Assistant
  • Kaya Schroeder, Student Assistant
  • Lee Lee Lim, Business Manager
  • Cassie Kim, Study Start-up Manager
  • Gergana Bozhilova-Deneva, Budget Fiscal Analyst
  • Gurleen Chaddha, Clinical Research Operations Specialist
  • Tien Nguyen, Budget Fiscal Analyst
  • Gabriel Andres, Clinical Trials Budget Coordinator
  • Sanya Cheeti, Student Assistant
  • John Thompson, MD (melanoma and renal)
  • Evan Hall, MD (melanoma and renal)
  • Jennifer Specht, MD (breast)
  • Shaveta Vinayak, MD (breast)
  • Rafael Santana-Davila, MD (head, neck and lung)
  • Andrew Coveler, MD (gastrointestinal)
  • Gabi Chiorean, MD (gastrointestinal)
  • Michael Schweizer, MD (genitourinary)
  • Elizabeth Swisher, MD (gynecological)
  • John B. Liao, MD, PhD (gynecological)
  • Banda, MD (gynecological)
  • Ajay Gopal, MD (hematology)
  • Annie Alidina, ARNP
  • Candace Mencias, Clinical Research Nurse Coordinator
  • Kim Sheppard, Clinical Research Nurse Coordinator
  • Mark Samuel, RN
  • Annie Alidina, ARNP
  • Peter Phrydas, Team Coordinator
  • Alina (Gigi) Yesiki, Pilot Pharmacist
  • Sarah Geiler, RN
  • Anneliese Schuessler, Pilot Pharmacist
  • Leslie Blackwell, CORS RN
  • Teresa Mata-Cervantes, CORS RC
  • Michael Peters, Senior Lab Manager
  • Josh Willard, Laboratory Scientist
  • Tim Johnson, Laboratory Scientist
  • Madhu Raman, Student Assistant
  • Minh Ramert, Clinical Trials Unit/ Acute Care Evaluation (ACE) Clinic Nurse Manger
  • Kimberly Ito, Clinical Trials Unit Nursing Supervisor 
  • Anna Stewart, Clinical Trials Unit Clinical Trials Coordinator
  • Nikki Mendoza, Clinical Trials Unit Clinical Trials Coordinator 
  • Rey Bonus, Clinical Trials Unit Clinical Trials Coordinator 

In Memoriam
Dana Snyder, CCRC, Senior Research Coordinator

  1. Falchook GS, Goff BA, Kurzrock R, Gray HJ, Martin LP, Coleman RL, Liu H, Zhou X, Benaim E, Schilder R, Phase I/II study of weekly paclitaxel with or without MLN8237 (alisertib), an investigational aurora A kinase inhibitor, in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (OC), or breast cancer (BrC): Phase 1 results, 2012, J Clin Oncol 30, abstr 5021.
  2. Adi Diab, Nizar Tannir, Daniel Cho, Vali Papadimitrakopoulou, Chantale Bernatchez, Cara Haymaker, Salah Eddine Bentebibel, Brendan Curti, Michael Wong, Scott Tykodi, Igor Puzanoff, Ira Smalberg, Ivan Gergel, Mary Tagliaferri, Jonathan Zalevsky, Ute Hoch, Sandra Aung, Michael Imperiale, Wendy Clemens, Harriet Kluger, Michael Hurwitz, Patrick Hwu, Mario Sznol.  Pivot-02: Preliminary safety, efficacy and biomarker results from the Phase 1/2 study of CD-122-biased agonist NKTR-214 plus nivolumab in patients with locally advanced/metastatic solid tumors.  Journal for ImmunoTherapy of Cancer2017 5(Suppl 2):86 (abstract O20).  7 November 2017.
  3. Lisa Johnson, Stephen Ansell, Robert Chen, IanFlinn, Michael Maris, Owen O'Connor, AlexanderLesokhin, John Thompson, Oleg Akilov, ChristianeQuerfeld, Matthew Taylor, Meghan Irwin, TinaCatalano, Penka Petrova, Eric Sievers, Robert Uger.  The checkpoint inhibitor TTI‐621 (SIRPαFc)stimulates innate and adaptive immuneresponses in patients with ematologic and solid tumor malignancies.    Journal for ImmunoTherapy of Cancer2017 5(Suppl 2):86 (abstract OP42).  7 November 2017.
  4. Zev Wainberg, Sarina Piha‐Paul, Jason Luke, EdwardKim, John Thompson, Nicklas Pfanzelter, MichaelGordon, Drew Rasco, Amy Weise, F. Stephen Hodi,Sandeep Inamdar, Serena Perna, Christy Ma,Janine Powers, Michael Carleton, Hong Xiang, Lei Zhou, Helen Collins, Yeonju Lee, James Lee,Jennifer Johnson, Carolyn Britten, MajidGhoddusi.  First‐in‐human phase 1 dose escalation andexpansion of a novel combination, anti–CSF‐1receptor (cabiralizumab) plus anti–PD‐1 (nivolumab),in patients with advanced solid tumors.  Late Breaking Abstract at 2017 SITC Congress.  O42: https://www.sitcancer.org/2017/abstracts/titles/late-breaking
  5. Modi S, Pusztai L, Forero A, Mita M, Miller KD, Weise A, Krop I, Burris III H, Kalinsky K, Tsai M, Liu MC, Hurvitz SA, Wilks S, Ademuyiwa F, Diab S, Han HS, Kato G, Nanda R, O'Shaughnessy J, Kostic A, Li M, Specht J. Phase 1 study of the antibody-drug conjugate SGN-LIV1A in patients with heavily pretreated triple-negative metastatic breast cancer. 2017 San Antonio Breast Confrence.
  6. A. Diab, O. Hamid, J. A. Thompson, W. Ro4, F. A. Eskens, T. Doi, S. Hu-Lieskovan, H. Long, T. Joh, S. Potluri8, X. Wang, C. Fleener, C. Turich Taylor, B. J. Ganguli, J. Chou, A. B. El-Khoueiry.  CT010 / 3 - Pharmacodynamic (PD) changes in tumor RNA expression and the peripheral blood T cell receptor (TCR) repertoire in a phase I study of OX40 agonistic monoclonal antibody (mAb) PF-04518600 (PF-8600).  AACR Annual Meeting, Poster Presentation, April 15 2018.
  7. T. Y. Seiwert1, R. Haddad2, J. Bauml3, J. Weiss4, D. G. Pfister5, S. Gupta6, R. Mehra7, I. Gluck8, H. Kang9, F. Worden10, J. Eder11, M. Tahara12, B. Burtness11, S. V. Liu13, A. Webber14, L. Huang14, R. Mogg14, R. Cristescu14, J. Cheng14, L. Q. M. Chow.  LB-339 - Biomarkers predictive of response to pembrolizumab in head and neck cancer (HNSCC).  AACR April 17 2018.
  8. N. M. Okeley1, R. A. Heiser1, W. Zeng1, S. M. Hengel1, J. Wall1, P. C. Haughney1, T. A. Yap2, F. Robert3, R. E. Sanborn4, H. Burris5, L. Q. M. Chow6, K. T. Do7, M. Gutierrez8, K. Reckamp9, A. Weise10, D. R. Camidge11, J. Strickler12, C. Steuer13, Z. Wang1, M. M. O'Meara1, S. C. Alley1, S. J. Gardai.  5551 / 7 - SGN-2FF: A small-molecule inhibitor of fucosylation modulates immune cell activity in preclinical models and demonstrates pharmacodynamic activity in early phase 1 analysis.  AACR April 18 2018.
  9. Johanna C. Bendell, Yung-Jue Bang, Cheng Ean Chee, David P. Ryan, Autumn Jackson McRee, Laura Q. Chow, Jayesh Desai, Matthew Wongchenko, Yibing Yan, Bethany Pitcher, Paul Foster, Edward Cha, William Grossman, Tae Won Kim.  A phase Ib study of safety and clinical activity of atezolizumab (A) and cobimetinib (C) in patients (pts) with metastatic colorectal cancer (mCRC).  GI ASCO 2018.
  10. Ian Chau, Nicolas Penel, Hendrik-Tobias Arkenau, Rafael Santana-Davila, Emiliano Calvo, Andres O. Soriano, Gu Mi, Jin Jin, David Ferry, Roy S. Herbst, Charles S. Fuchs.  Safety and antitumor activity of ramucirumab plus pembrolizumab in treatment naïve advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma: Preliminary results from a multi-disease phase I study (JVDF).  GI ASCO 2018.
  11. T M Bauer, M Barve, E G Chiorean, P Lorusso, K Courtney, D Qi, A Olguin, J Bullington, M Sardone, V Dunn, S Shemesh, J Chen, C Brooks, J Wang; 428P
    Interim results from a phase I trial of SL-801: A novel XPO-1 inhibitor, in patients with advanced solid tumors, Annals of Oncology, Volume 29, Issue suppl_8, 1 October 2018, mdy279.415, https://doi.org/10.1093/annonc/mdy279.415
  12. Nehal Lakhani, MD, PhD; Patricia LoRusso, DO; Laura Q. Chow, MD; Yung-Jue Bang, MD PhD; Philip Fanning; Yonggang Zhao, PhD, MBA; Jaume Pons; Hong Wan; Sophia S. Randolph, MD, PhD; Wells Messersmith, MD. A phase 1 study of ALX148: CD47 blockade in combination with anticancer antibodies to bridge innate and adaptive immune responses for advanced malignancy.  SITC Abstract November 2018.
  13. Feng Jin, PhD; Nehal Lakhani, MD, PhD; Patricia LoRusso, DO; Laura Q. Chow, MD; Wells Messersmith, MD; Sangetha Bollini; Laura Doyle; Steven Kauder, PhD; Philip Fanning; Jaume Pons; Sophia S. Randolph, MD, PhD; Hong Wan.  Pharmacokinetic and pharmacodynamic characterization of ALX148, a CD47 blocker, in patients with advanced malignancy and non-Hodgkin lymphoma.  SITC Abstract November 2018. 
  14. S P Chawla, S Pollack, M Block, M Druta, K Do, J C Morris, J W Kim, C Bohac, H Lu, S Gnjatic, R L Jones, P Hwu, N Somaiah; 1607PD
    Immune response, safety, and overall survival of NY-ESO-1+ soft tissue sarcoma patients treated with CMB305 therapy, Annals of Oncology, Volume 29, Issue suppl_8, 1 October 2018, mdy299.006, https://doi.org/10.1093/annonc/mdy299.006
  15. J Specht, L Pusztai, A Forero-Torres, M Mita, A Weise, I Krop, A Grosse-Wilde, Z Wang, M Li, S Hengel, P Garfin, G Means, M Onsum, S Modi; 286PD
    Post-treatment biopsies show evidence of cell cycle arrest and immune cell infiltration into tumors of ladiratuzumab vedotin-treated advanced breast cancer patients, Annals of Oncology, Volume 29, Issue suppl_8, 1 October 2018, mdy272.278, https://doi.org/10.1093/annonc/mdy272.278
  16. Zev A. Wainberg, Howard S. Hochster, Edward Jae-Hoon Kim, Ben George, Aparna Kalyan, E. Gabriela Chiorean, David Michael Waterhouse, Martin Gutierrez, Aparna Raj Parikh, Rishi Jain, Daniel R. Carrizosa, Hatem Hussein Soliman, Rafia Bhore, Sibabrata Banerjee, Larry Lyons, Chrystal Ursula Louis, Teng Jin Ong, Peter J. O'Dwyer; Phase I study of nivolumab (Nivo) + nab-paclitaxel (nab-P) + gemcitabine (Gem) in advanced pancreatic cancer (APC). GI ASCO January 2019.
  17. E. Garon1, A. Spira2, M. Johnson3, L. Bazhenova4, J. Leach5, A. Candia6, R.L. Coffman6, M. Janatpour6, E. Gamelin6, R. Janssen6, L.Q.M. Chow7. Abstract 8304: Phase 1b, Open Label, Multicenter Study of Inhaled DV281, a Toll-like Receptor 9 Agonist, in Combination with Nivolumab in Patients with Second- or Third-Line Advanced or Metastatic Non Small Cell Lung Cancer (NCT03326752). AACR April 2019.
  18. Kevin Conlon,1 Rom Leidner,2 Douglas McNeel,3 Sumati Gupta,4 Andrea Wang-Gillam,5 Thomas A. Waldmann,1 George N. Pavlakis,1 Mirek Dostalek,6 Sema Kurtulus,6 Niladri Roy Chowdhury,7 Jessica O’Kee‰e, Nehal S. Parikh,6 John Thompson8. Phase I/Ib study of NIZ985 with and without spartalizumab (PDR001) in patients with metastatic/unresectable solid tumors. AACR April 2019.
  19. "Timothy Anthony Yap1, Justin F. Gainor2, Margaret K. Callahan3, Gerald S. Falchook4, Russell Kent Pachynski5, Patricia LoRusso6, Shivaani Kummar7, Geoffrey Thomas Gibney8, Howard A. Burris9, Scott S. Tykodi10, Osama E. Rahma11, Tanguy Y. Seiwert12, Kyriakos P. Papadopoulos13, Ellen Hooper14, Christopher J. Harvey14, Amanda Hanson14, Sean Lacey14, Rachel McComb14, Courtney Hart14, Haley Laken14, Ty McClure14 and Elizabeth Trehu114. Improved Progression-Free and Overall Survival (PFS/OS) in Patients (pts) with Emergence of JTX-2011 (vopratelimab) Associated Biomarker (ICOS high CD4 T cells) on the ICONIC Trial. AACR April 2019."
  20. Laura QM Chow1, Justin Gainor2, Nehal Lakhani3, Hyun Chung4, Keun-Wook Lee5, Jeeyun Lee6, Patricia LoRusso7, Yung-Jue Bang8, Stephen Hodi9, Philip Fanning10, Pierre Squifflet11, Yonggang Zhao10, Feng Jin10, Hong Wan10, Jaume Pons10, Sophia Randolph10, Wells Messersmith.  A Phase 1 Study of ALX148, a CD47 Blocker, in Combination with Established Anticancer Antibodies in Patients with Advanced Malignancy.  ASCO 2019.
  21. Justin F. Gainor1, Dae Ho Lee2, Giuseppe Curigliano3, Robert C. Doebele4, Dong-Wan Kim5, Christina S. Baik6, Daniel Shao-Weng Tan7, Gilberto Lopes8, Shirish M. Gadgeel9, Philippe Alexandre Cassier10, Matthew H. Taylor11, Stephen V. Liu12, Benjamin Besse13, Michael Thomas14, Viola Weijia Zhu15, Hui Zhang16, Corinne Clifford16, Michael R. Palmer16, Christopher D. Turner16, Vivek Subbiah.  Clinical Activity and Tolerability of BLU-667, a Highly Potent and Selective RET Inhibitor, in Patients with Advanced RET-Fusion+Non-small Cell Lung Cancer. ASCO 2019.
  22. Matthew H. Taylor1, Justin F. Gainor2, Mimi I-Nan Hu3, Viola Weijia Zhu4, Gilberto Lopes5, Sophie Leboulleux6, Marcia S. Brose7, Martin H. Schuler8, Daniel W. Bowles9, Dong-Wan Kim10, Christina S. Baik11, Elena Garralda12, Chia-Chi Lin13, Douglas Adkins14, Debashis Sarker15, Giuseppe Curigliano16, Hui Zhang17, Corinne Clifford17, Michael R. Palmer17, Christopher D. Turner17, Vivek Subbiah3.  Activity and Tolerability of BLU-667, a Highly Potent and Selective RET Inhibitor, in Patients with Advanced RET-altered Thyroid Cancers.  ASCO 2019.
  23. Christiane Querfeld1, John A. Thompson2, Matthew Taylor3, Raju Pillai1, Lisa DS. Johnson4, Tina Catalano4, Penka S. Petrova4, Bob A. Uger4, Meghan Irwin4, Theresa Thompson4, Eric L. Sievers4, Oleg Akilov.  Intralesional Injection of the CD47-blocking immune checkpoint inhibitor TTI-621 (SIRPaFc) induces antitumor activity in patients with relapsed/refractory mycosis fungoides and Sézary syndrome: Interim results of a multicenter Phase 1 trial. DOI: https://doi.org/10.1016/j.ejca.2018.07.297
  24. R. Kim1, J. Chaves, P. Kavan, M. Fakih, J. Kortmansky, K. Spencer, L. Wong, M. Tehfe, J.J. Li, M. Lee, C. Mayo, P. Marinello, E. Chiorean, Annals of Oncology (2019) 30 (suppl_5): v198-v252. 10.1093/annonc/mdz246. ESMO Sep 2019
  25. CodeBreak 100: Phase I study of AMG 510, a novel KRASG12C inhibitor, in patients with advanced solid tumors other than non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).
  26. Registrational dataset from the phase 1/2 ARROW trial of pralsetinib (BLU-667) in patients (pts) with advanced RET fusion+ non-small-cell lung cancer (NSCLC).Justin F. Gainor, Giuseppe Curigliano, Dong-Wan Kim, Dae Ho Lee, Benjamin Besse, Christina S Baik, Robert C Doebele, Philippe Alexandre Cassier, Gilberto Lopes, Daniel Shao-Weng Tan, Elena Garralda, Luis G. Paz-Ares, Byoung Chul Cho, Shirish M. Gadgeel, Michael Thomas, Stephen V. Liu, Corinne Clifford, Hui Zhang, Christopher D. Turner, Vivek Subbiah
  27. Phase I study of SEA-CD40, gemcitabine, nab-paclitaxel, and pembrolizumab in patients with metastatic pancreatic ductal adenocarcinoma (PDAC).
  28. SEA-CD40, a non-fucosylated CD40 agonist: Interim results from a phase 1 study in advanced solid tumors. J Clin Oncol 36, 2018 (suppl; abstr 3093)uneko E. Grilley-Olson, Brendan D. Curti, David C. Smith, Sanjay Goel, Thomas Gajewski, Svetomir Markovic, Olivier Rixe, David Lawrence Bajor, Martin Gutierrez, Timothy Kuzel, Amitkumar N. Mehta, Benny Amore, Abraham Guerrero, Zejing Wang, Andrew L. Coveler; 
  29. Results from the registrational phase I/II ARROW trial of pralsetinib (BLU-667) in patients (pts) with advanced RET mutation-positive medullary thyroid cancer (RET+ MTC)Annals of Oncology (2020) 31 (suppl_4): S1026-S1033. 10.1016/annonc/annonc293.M. Hu1, V. Subbiah2, L.J. Wirth3, M. Schuler4, A.S. Mansfield5, M.S. Brose6, G. Curigliano7, S. Leboulleux8, V.W. Zhu9, B. Keam10, I. Matos11, C. Lin12, D. Adkins13, C.S. Baik14, G. Lopes15, Y. Godbert16, D. Sarker17, H. Zhang18, C. Turner18, M. Taylor1
  30. FUZE clinical trial: a phase 2 study of Debio 1347 in FGFR fusion-positive advanced solid tumors irrespectively of tumor histology.J Clin Oncol 37, 2019 (suppl; abstr TPS3157)
  31. Phase I/II study of SAR439859, an oral selective estrogen receptor degrader (SERD), in estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC). Mario Campone, Aditya Bardia, Gary A. Ulaner, Sarat Chandarlapaty, Alice Gosselin, Séverine Doroumian, Vasiliki Pelekanou, Marina Celanovic, and Hannah M. Linden. Journal of Clinical Oncology 2020 38:15_suppl, 1070-1070
  32. SAR439859, an oral selective estrogen receptor (ER) degrader (SERD), in ER+/ HER2- metastatic breast cancer (mBC): Biomarker analyses from a phase I/II study. S. Chandarlapaty1, A. Bardia2, S. Lord3, H. Linden4, V. Pelekanou5, N. Ternes6, J. Ming7, V. Boutet8, E. Boitier8, A. Gosselin6, J. Sang Lee9, W. Dos-Santos Bele10, A. Protopopov9, M. Celanovic11, A. Bauchet8, M. Campone12. Annals of Oncology (2020) 31 (suppl_4): S348-S395. 
  33. A Phase 1/2 study of SAR439859, an oral selective estrogen receptor (ER) degrader (SERD), as monotherapy and in combination with other anti-cancer therapies in postmenopausal women with ER-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC): AMEERA-1 Linden HM, Campone M, Bardia A, Ulaner GA, Gosselin A, Doroumian S, Pelekanou V, Celanovic M, Chandarlapaty S. 2020 SABCS  PD8-08 
  34. Phase I/Ib first-in-human study of HEK-NIZ985, a recombinant IL-15/IL-15Rα heterodimer, alone and in combination with spartalizumab, in adults with advanced and metastatic solid tumors.John A thompson. University of Washington Seattle Cancer Care. 2020 SITC (386)
  35. End-of-life health care utilization (EOLHCU) in patients with thoracic, head and neck cancers with or without phase I study participation at a single institution.Dominic Min-Tran, Annika Gustafson, Keith D. Eaton, Elizabeth Trice Loggers, Cristina P. Rodriguez, Rafael Santana-Davila. J Clin Oncol 38: 2020 (suppl; abstr e19153)
  36. Phase II trial of the CDK4/6 inhibitor abemaciclib in patients (pts) with advanced and refractory well‐differentiated gastroenteropancreatic neuroendocrine tumors (GEP NETs).Kit Man Wong, Bojana Irene Askovich, Harini Ramachandran, Jeniece Hensel, Susan Ottermiller, Annie Alidina, Reina Hibbert, Andrew L. Coveler, John A. Thompson, Elena Gabriela Chiorean;J Clin Oncol 39, 2021 (suppl 3; abstr TPS376)
  37. Phase I study of SEA-CD40, gemcitabine, nab-paclitaxel, and pembrolizumab in patients (pts) with metastatic pancreatic ductal adenocarcinoma (PDAC) (trial in progress).David Lawrence Bajor, Martin Gutierrez, Gina M. Vaccaro, Ashiq Masood, Ursa Abigail Brown-Glaberman, Juneko E. Grilley-Olson, Milind M. Javle, Hedy L. Kindler, Olumide B. Gbolahan, Anthony Frank Shields, Mark Zalupski, Michael W. Schmitt, Andrew L. Coveler;J Clin Oncol 39, 2021 (suppl 3; abstr TPS451)
  38. SGNLVA-001: A phase I open-label dose escalation and expansion study of SGN-LIV1A administered weekly in breast cancer.Heather Christine Beckwith, Diana Cristina Medgyesy, Jame Abraham, Rita Nanda, Katherine H. R. Tkaczuk, Ian E. Krop, Lajos Pusztai, Shanu Modi, Monica M. Mita, Jennifer M. Specht, Sara A. Hurvitz, Hyo S. Han, Kevin Kalinsky, Sharon Wilks, Joyce O'Shaughnessy, Lowell L. Hart, Hope S. Rugo, Zahi Ibrahim Mitri, Phillip M. Garfin, Howard A. Burris III;J Clin Oncol 38: 2020 (suppl; abstr TPS1104)
  39. AMEERA-1: Phase 1/2 study of amcenestrant (SAR439859), an oral selective estrogen receptor (ER) degrader (SERD), with palbociclib (palbo) in postmenopausal women with ER+/ human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC).J Clin Oncol 39, 2021 (suppl 15; abstr 1058)
  40. Phase 1/2 dose-escalation and expansion study investigating SAR439859 +/- palbociclib in postmenopausal women with estrogen receptor-positive (ER+)/HER2- metastatic breast cancer.Aditya Bardia, Hannah M. Linden, Gary A. Ulaner, Sarat Chandarlapaty, Alice Gosselin, Marina Celanovic, Mario Campone; J Clin Oncol 37, 2019 (suppl; abstr TPS1105)
  41. Dose-escalation study of SAR439859, an oral selective estrogen receptor (ER) degrader (SERD), in postmenopausal women with ER+/HER2- metastatic breast cancer (mBC).Aditya Bardia, Hannah M. Linden, Gary A. Ulaner, Sarat Chandarlapaty, Alice Gosselin, Séverine Doroumian, Marina Celanovic, Mario Campone. J Clin Oncol 37, 2019 (suppl; abstr 1054)
  42. PF‑06939999, a potent and selective PRMT5 inhibitor, in patients with advanced or metastatic solid tumors: A phase 1 dose escalation study.Jordi Rodon Ahnert, Cesar Augusto Perez, Kit Man Wong, Michael L. Maitland, Frank Tsai, Jordan Berlin, Kai Hsin Liao, I-Ming Wang, Lada Markovtsova, Ira A Jacobs, Nora Cavazos, Meng Li, Anthony W. Tolcher;J Clin Oncol 39, 2021 (suppl 15; abstr 3019)
  43. Phase 1b dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of GS-3583, a FLT3 agonist Fc fusion protein, in patients with advanced solid tumors.Joshua Brody, John A. Thompson, Anthony W. Tolcher, Michelle R. Kuhne, Xi (Rochelle) Huang, Ellen Kwan, Michael Petrarca, Anees Dauki, Indrajeet Singh, Nishanthan Rajakumaraswamy, Shivaani Kummar;J Clin Oncol 39, 2021 (suppl 15; abstr TPS3147)
  44. First-in-human phase I/II study of CYT-0851, a first-in-class inhibitor of RAD51-mediated homologous recombination in patients with advanced solid and hematologic cancers.Ryan C Lynch, Johanna C. Bendell, Ranjana H. Advani, Gerald Steven Falchook, Pamela N. Munster, Manish R. Patel, Martin Gutierrez, Monika Leigh Burness, Neil Palmisiano, Mehdi Hamadani, William D Bradley, Thomas J O'Shea, Susan Doleman, Markus Frederic Renschler, Judson M. Englert, Timothy A. Yap J Clin Oncol 39, 2021 (suppl 15; abstr 3006)
  45. SEA-CD40, gemcitabine, nab-paclitaxel, and pembrolizumab in pts with metastatic pancreatic cancer.               Coveler et al. J Clin Oncol 41, 2023 (suppl 4; abstr 708
  46. F-06821497, a selective inhibitor of EZH2, in pts with metastatic castration-resistant prostate cancer. Schweizer et al. J Clin Oncol 41, no. 6_suppl (February 20, 2023).
  47. CYT-0851, a first-in-class inhibitor of RAD51-mediated homologous recombination, in pts with advanced solid and hematologic cancers.  Lynch et al. J Clin Oncol 40, 2022 (suppl 16; abstr 3084)
  48. XmAb23104 (PD-1 x ICOS) in subjects with selected advanced solid tumors (DUET-3).                                          Specht, etc. J Clin Oncol 40, 2022 (suppl 16; abstr 2604)
  49. PC14586, a small molecule structural corrector of Y220C mutant p53, in pts harboring a TP53 Y220C mutation. Thompson et al. J Clin Oncol 40, 2022 (suppl 16; abstr 3003)
  50. Phase I trial of PF-06821497, a potent and selective inhibitor of enhancer of zeste homolog 2 (EZH2), in follicular lymphoma (FL), small cell lung cancer (SCLC) and castration-resistant prostate cancer (CRPC). Annals of Oncology (2022) 33 (suppl_7): S197-S224. 10.1016/annonc/annonc1049
  51. Non-comparative, open-label, international, multicenter phase I/II study of nivolumab (NIVO) ± ipilimumab (IPI) in patients (pts) with recurrent/metastatic Merkel cell carcinoma (MCC) (CheckMate 358). Journal of Clinical Oncology 41, no. 16_suppl (June 01, 2023) 9506-9506.
  52. EZH2/EZH1 inhibitor tulmimetostat (CPI-0209) in patients with advanced solid tumors or hematologic malignancies: Preliminary phase II results.Journal of Clinical Oncology 2023 41:16_suppl, 3094-3094
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