Phase 1 Clinical Trials Program

Contact Us

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

Mailing Address

825 Eastlake Ave. E.
Mailstop LG-350
Seattle, WA  998109-1024

In a phase 1 clinical trial, small groups of participants get a new drug, or a combination of several drugs, that has shown anti-cancer promise in test tubes and animals and is being tested for the first time in humans.

This is an important step in testing new therapies. People who join clinical trials can help researchers better understand cancer and how to treat it, and they may also be helping future patients who could benefit from a new therapy. 

At Fred Hutch Cancer Center, our Phase 1 Clinical Trials Program includes patients with advanced cancer and disease who have already tried standard treatments. The program provides a full range of research services and brings together leading researchers and cancer experts to:

  1. Find a safe dose of a new treatment or drug that is being tested
  2. Decide how the new treatment should be given (by mouth, in a vein or another way)
  3. Observe participants over time, collect data and see how the new treatment affects the body and fights cancer
  4. Find out how well the treatment or drug works against cancer

NIH Research Shows Benefits to Patients

In the past few years, many promising new cancer drugs have been developed that were studied in phase 1 clinical trials first, like immunotherapies , targeted therapies and combinations of these therapies. Clinical trials can also help us find better ways to manage and deliver palliative care and other supportive patient care.

Research suggests these improved factors may have a positive impact on patients who participate in phase 1 clinical trials. The National Cancer Institute (NCI), which is part of the National Institutes of Health (NIH), did a survey in 2022 of the NCI’s Cancer Therapy Evaluation Program (CTEP). The study looked at CTEP’s Phase 1 clinical trials for solid tumors that were done from 2000–2019 and sponsored by CTEP. They found out that:

  • The number of trial participants whose tumors shrank or disappeared nearly doubled
  • The percentage of patients whose tumors stopped growing for a time increased
  • The risk of death caused by a new treatment being tested remained steady at less than 1%

Learn More at NIH  |  Read the Study

About the Program

We start by partnering with leading pharmaceutical companies to get the promising new drugs they are developing into our phase 1 trials, so we can better understand how they affect patients with cancer. These might include immune-modifying agents like 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.

Next, we work with researchers from our Cancer Consortium, which brings together experts from Fred Hutch, the University of Washington and Seattle Children’s. By working together, we are able to use the latest technology and resources, such as world-class positron emission tomography (PET) imaging, proteomics, biomarkers and genomics cores.

Using these tools, we can conduct studies that try to find out if there are connections between factors like genes or proteins and how well a treatment works (also called correlative studies). Together, we can gather even better data than we could on our own.

Here are some examples of cancer therapies that were tested in phase 1 clinical trials at Fred Hutch and later got approved by the FDA: 

  • Acalabrutinib
  • Atezolizumab
  • Avelumab
  • Ceritinib
  • Dostarlimab
  • Entrectinib
  • Ipilimumab
  • Ladiratuzumab vedotin
  • Nivolumab
  • Obinutuzumab
  • Pembrolizumab
  • Pralsetinib
  • Regorafenib
  • Talazoparib

Patient-Focused Clinical Trials Unit

In a phase 1 clinical trial, patients come to our clinic more often than they would for traditional cancer treatment. They also have tests and procedures so researchers can collect the data they need to understand if, and how, the new drug is working.

Our outpatient Clinical Trials Unit (for patients who are not staying overnight) was designed to support patients and their families during this process, and includes:

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

Our outpatient Clinical Trials Unit is located at our South Lake Union Clinic and is open from Monday through Friday, 8 a.m. to 10 p.m. Patients who need to stay overnight at the hospital will stay at UW Medical Center – Montlake.
 

Frequently Asked Questions

Referring Provider  |  Patient — About the Program  |  Patient — After You Join the Program

Referring Provider

To assess your patient's eligibility for the Fred Hutch Phase 1 Clinical Trials Program, contact us at phase1clinicaltrial@fredhutch.org.

We provide participants with a consent form explaining what researchers know about the experimental drug and/or how the drug might affect them. Your patient will be encouraged to review the form in detail with their family, friends and health care providers.  

Our phase 1 clinical trials are conducted under the FDA’s regulations and the International Harmonization Committee’s Good Clinical Practices. Our staff also work closely with institutional investigators, industry partners and review committees to ensure that your patient’s rights, safety and welfare are protected. Reviews include scientific committee review, radiation safety review and institutional review board (IRB) review.

Your patient's well-being is our priority. We will closely monitor their health, manage any side effects, answer questions and help keep them as comfortable as possible. We will also provide clear, regular communication so they stay well informed. If, for some reason, your patient decides to leave the program and does not enroll in another early-phase clinical trial, we will refer them back to you. 

Patient — About the Program

No. Phase 1 clinical trials are highly technical and require specialized experts, facilities and resources to make sure that people who join the study are safe and that the trial is run correctly. Fred Hutch started the first university-based phase 1 clinical trials program for cancer research in the Pacific Northwest, and we continue to lead the way today. 

We usually work with people who have a solid tumor, which is a mass or lump of tissue that is made up of abnormal or cancerous cells that grow uncontrollably. Solid tumors can grow in any organ system, like the lungs, colon, skin, breast or bladder. 

People who sign up for phase 1 trials often have advanced or difficult-to-treat cancers and have already tried standard treatment options. If you are interested in learning more or think you may want to join a trial, talk to your physician about referring you or contact us to learn more. 

Yes. Cancer is complex, and every type of cancer is different and needs to be treated differently. The knowledge that researchers learn from your experience can help them better understand how to treat cancer and may even lead to better treatments that can help others in the future. 

When you join a phase 1 clinical trial, you are helping researchers understand how cancer works and what the best ways to treat it might be. Your experience helps them learn more about the treatment's safety, how it works and its effects on the human body. 

Phase 1 clinical trials begin with small groups (cohorts) of three to six patients to see what the experimental treatment does to people. Next, if the drug is safe to use, the next cohort starts the trial at a higher dose. Once researchers have figured out the recommended dose, more patients may be enrolled (up to 100).

Patient — After You Join the Program

You will need to come in for regular appointments, checkups and tests. You will also see us more often than if you were having a regular cancer treatment. We will ask you questions to understand your experience and how the study drug is affecting you. 

Researchers start with a small dose of the new treatment and slowly increase it. They will closely monitor how you respond to it and make sure it is safe. This steady approach helps find the best balance between effectiveness and safety. 

It is common to have side effects during phase 1 clinical trials. At Fred Hutch, our team is here to help and keep you as comfortable as possible. Our team has four Phase 1 Clinical Trial nurses who meet new patients and form relationships. Patients work with the phase 1 nurses to provide information about their medical conditions, side effects and management of side effects that is put into reports. If you notice any side effects or changes in your health, you should let your care team know as soon as possible. 

The team will regularly check your health and do tests to see how the treatments are working.  This may include taking images of the areas of your body where you have cancer to see if they change during the study. The team will also take tissue samples from you to see how the cancer cells are reacting to the drug. Because we are learning new things during our clinical trials, we will tell you when we have new information about the drug we are studying.  

Each trial is different. Typically, patients stay in the study until they’ve reached maximum benefit or until they encounter side effects that lead them to stop treatment. 

Yes, you have the right to stop participating at any time. Your decision will not affect your regular medical care. 

Yes! The Phase 1 Clinical Trials Program providers work closely with your primary oncologist to make sure that your transition back into their care is seamless.

Sometimes the companies that make the drugs we are studying will make them available after the study is over to people who qualify through programs called “expanded access.” 

Phase 1 Program Team

Our highly skilled staff, nurses and physicians have extensive research experience. They provide the careful, compassionate care and attention that is needed to work with patients and test possible new 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

Senior Ops, Director, Phase 1 Clinical Trials Program, Fred Hutch

For More Information

Phone: 206.606.7551
Fax: 206.606.6681

Research Coordinator Team

  • Hannah Lee, CCRC, Senior Research Manager
  • LyTieng Huot, Assistant Research Manager
  • Harini Ramachandran, Principal Research Coordinator
  • Elizabeth Liu, Research Coordinator
  • Amanda Ramsing-Lund, Research Coordinator
  • Jordan Campbell, Research Coordinator, 
  • Heidi Lee, Research Coordinator
  • Sheila Pagtakhan, Research Coordinator
  • Alice Ranjan, Research Coordinator
  • Prisca Lin, Research Coordinator

Data Coordinator Team

  • Jeniece Hensel, CCRP, Senior Research Data Manager
  • Meghan Blakesley, CCRP, Associate Data Manager
  • Alice Tran, Principal Data Lead
  • Sophia Gould, Senior Data Coordinator
  • Caroline McKewan, Data Coordinator
  • Meagan Tumy, Data Coordinator
  • Jessica Sanchez, Data Coordinator
  • Tatjana Poe, Data Coordinator
  • Becca Fox, Research Study Assistant
  • Reina Hibbert, CCRC, Principal Regulatory Affairs Manager
  • Patrick Toler, Principal Regulatory Coordinator
  • Jordan Cooper, Senior Regulatory Affairs Coordinator 
  • Rajee Pandey, Regulatory Coordinator
  • Elizabeth Shang, Junior Regulatory Coordinator
  • Lee Lee Lim, Business Manager
  • Cassie Kim, Study Start-up Manager
  • Gergana Bozhilova-Deneva, Budget Fiscal Analyst
  • Gurleen Chaddha, Clinical Research Operations Specialist
  • Gabriel Andres, Clinical Trials Budget Coordinator
  • John Thompson, MD (melanoma and renal)
  • Evan Hall, MD (melanoma and renal)
  • Jennifer Specht, MD (breast)
  • Shaveta Vinayak, MD (breast)
  • Lynn Symonds, MD (breast)
  • Vyshak Venur, MD (head, neck and lung)
  • 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)
  • Vivian Oehler, MD (Translational Science and Therapeutics Division)
  • Annie Alidina, ARNP
  • Candace Mencias, Clinical Research Nurse Coordinator
  • Kim Sheppard, CRT RN
  • Peter Phrydas, Team Coordinator
  • Alina (Gigi) Yesiki, Pilot Pharmacist
  • Anneliese Schuessler, Pilot Pharmacist
  • Leslie Blackwell, Clinical Research Nurse
  • Teresa Mata-Cervantes, CRT RN
  • Michael Peters, Senior Lab Manager
  • Josh Willard, Laboratory Scientist
  • Timothy Johnson, Laboratory Scientist
  • Julie Lewin, Pilot Pharmacist
  • Sarah Brown, Clinical Research Nurse Coordinator
  • Vanessa Caixeta Flynn, Clinical Research Nurse Coordinator
  • Elissa Farinas, Clinical Research Nurse Coordinator
  • Paige Seehausen, Clinical Research Nurse Coordinator
  • Jeffrey Noel Abando, Clinical Research Nurse Coordinator
  • Kimberly Ito, Clinical Trials Unit Nursing Supervisor 
  • Tate Weeks, Clinical Trials Unit Nurse Manager
  • Anna Furrow, Clinical Trials Unit Clinical Trials Coordinator
  • Rey Bonus, Clinical Trials Unit Clinical Trials 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
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  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.
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  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.
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  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
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    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."
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  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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