AlexanderISpiraMD

Oncology • Fairfax, VA

Cancer Genetics/Cancer Risk Assessment, Hematologic Oncology, Sarcoma, Thoracic Cancer

Virginia Cancer Specialists

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Office
8613 Lee Hwy
200
Fairfax, VA 22031
Phone+1 703-280-5390

Fax+1 703-280-9596
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Education & Training

Johns Hopkins UniversityFellowship, Hematology and Medical Oncology, 2000 - 2003
University of Pennsylvania Health SystemResidency, Internal Medicine, 1997 - 2000
New York University School of MedicineClass of 1997

Certifications & Licensure

VA State Medical License 2003 - 2026
MD State Medical License 2000 - 2003
PA State Medical License 1998 - 2000
American Board of Internal Medicine Medical Oncology

Awards, Honors, & Recognition

Top Doctors:Washington DC Area Castle Connolly, 2012
Top Doctors:Washington-Baltimore Castle Connolly, 2012
Top MD Consumers Checkbook

Clinical Trials

Study of the Safety and Efficacy of TH-302 in Combination With Gemcitabine Compared With Gemcitabine Alone in Previously Untreated Patients With Pancreatic Adenocarcinoma Start of enrollment: 2010 Jun 01
Completed
Phase 2
Tivantinib Plus Erlotinib Versus Placebo Plus Erlotinib for the Treatment of Non-squamous, Non-small-cell Lung Cancer Start of enrollment: 2011 Jan 11
Terminated
Phase 3
A Study of BBI608 Administered With Paclitaxel in Adult Patients With Advanced Malignancies Start of enrollment: 2011 Apr 01
Completed
Phase 1, Phase 2
A Study of AT13387 in Patients With Non-Small Cell Lung Cancer (NSCLC) Alone and in Combination With Crizotinib Start of enrollment: 2012 Oct 01
Completed
Phase 1, Phase 2
A Study of BBI503 in Adult Patients With Advanced Solid Tumors Start of enrollment: 2012 Feb 01
Completed
Phase 1
LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib Start of enrollment: 2013 Jun 28
Completed
Phase 3
Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib Start of enrollment: 2013 Aug 01
Completed
Phase 2
BKM120 for Patients With PI3K-activated Tumors Start of enrollment: 2013 Mar 29
Completed
Phase 2
Chemotherapy Plus Cetuximab in Combination With VTX-2337 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Start of enrollment: 2013 Oct 14
Completed
Phase 2
A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Etoposide and Platinum Therapy Start of enrollment: 2012 Jan 07
Terminated
Phase 1, Phase 2
MEK162 for Patients With RAS/RAF/MEK Activated Tumors Start of enrollment: 2013 Oct 10
Completed
Phase 2
Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma Start of enrollment: 2013 Dec 13
Active, not recruiting
Phase 3
Mifepristone and Eribulin in Patients With Metastatic Triple Negative Breast Cancer or Other Specified Solid Tumors Start of enrollment: 2014 Jan 01
Completed
Phase 1
Study of IDO Inhibitor and Temozolomide for Adult Patients With Primary Malignant Brain Tumors Start of enrollment: 2014 Mar 01
Completed
Phase 1, Phase 2
Multicenter Study of Rociletinib Administered to Patients With Previously Treated Mutant EGFR Non-small Cell Lung Cancer Start of enrollment: 2014 Jun 16
Terminated
Phase 2
A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma Start of enrollment: 2015 Sep 14
Active, not recruiting
Phase 3
Trilaciclib (G1T28) in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy Start of enrollment: 2015 Oct 05
Terminated
Phase 1, Phase 2
Study of STRO-001, an Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-Cell Malignancies Start of enrollment: 2018 Feb 22
Active, not recruiting
Phase 1
A Study to Evaluate Immunotherapy Combinations in Participants With Lung Cancer Start of enrollment: 2019 Apr 01
Active, not recruiting
Phase 1
Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer Start of enrollment: 2020 May 28
Active, not recruiting
Phase 2
A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors Start of enrollment: 2020 Feb 24
Recruiting
Phase 1, Phase 2
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Start of enrollment: 2020 Sep 29
Active, not recruiting
Phase 2
PLX2853 as a Single Agent in Advanced Gynecological Malignancies and in Combination With Carboplatin in Platinum-Resistant Epithelial Ovarian Cancer Start of enrollment: 2020 Aug 11
Terminated
Phase 1, Phase 2
Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies Start of enrollment: 2020 Oct 12
Active, not recruiting
Phase 1
A Study of STRO-002, an Anti-Folate Receptor Alpha Antibody Drug Conjugate, in Combination With Bevacizumab in Epithelial Ovarian Cancer Start of enrollment: 2022 Mar 22
Recruiting
Phase 1
Roles: Contact
Pepinemab in Combination With Pembrolizumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Start of enrollment: 2021 Aug 09
Recruiting
Phase 1, Phase 2
Roles: Contact
Study of TPX-0022 in Patients With Advanced NSCLC, Gastric Cancer or Solid Tumors Harboring Genetic Alterations in MET Start of enrollment: 2019 Sep 21
Active, not recruiting
Phase 1, Phase 2
Roles: Contact
A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer Start of enrollment: 2019 Apr 19
Active, not recruiting
Phase 3
Roles: Principal Investigator
RTX-240 Monotherapy and in Combination With Pembrolizumab Start of enrollment: 2020 May 06
Terminated
Phase 1, Phase 2
Roles: Contact
ASCO Survey on COVID-19 in Oncology (ASCO) Registry Start of enrollment: 2020 Apr 19
Active, not recruiting
Roles: Contact
A Study of NM21-1480 in Adult Patients With Advanced Solid Tumors Start of enrollment: 2020 Aug 19
Terminated
Phase 1, Phase 2
Roles: Contact
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist) Start of enrollment: 2019 Dec 10
Recruiting
Phase 1
Roles: Contact
A Study of TAK-981 Given With Pembrolizumab in Participants With Select Advanced or Metastatic Solid Tumors Start of enrollment: 2020 Aug 17
Active, not recruiting
Phase 1, Phase 2
Roles: Principal Investigator
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Publications & Presentations

PubMed

Adagrasib Treatment After Sotorasib-Related Hepatotoxicity in Patients With-Mutated Non-Small Cell Lung Cancer: A Case Series and Literature Review.
Anjali Donnelly, Kevin Lu, Debra Ryan, Jia Luo, Narjust Florez, Yanyan Lou, Patrick C Ma, Alexander I Spira, Hatim Husain> ;JCO Precision Oncology. 2024 Apr 1
A shared neoantigen vaccine combined with immune checkpoint blockade for advanced metastatic solid tumors: phase 1 trial interim results.
Amy R Rappaport, Chrisann Kyi, Monica Lane, Meghan G Hart, Melissa L Johnson, Brian S Henick, Chih-Yi Liao, Amit Mahipal, Ardaman Shergill, Alexander I Spira, Jonathan...> ;Nature Medicine. 2024 Mar 27
A phase Ib study evaluating the recommended phase II dose, safety, tolerability, and efficacy of mivavotinib in combination with nivolumab in advanced solid tumors.
Dejan Juric, Minal Barve, Ulka Vaishampayan, Desamparados Roda, Aitana Calvo, Noelia Martinez Jañez, Jose Trigo, Alastair Greystoke, R Donald Harvey, Anthony J Olszans...> ;Cancer Medicine. 2024 Mar 1
1 citations
Clinical outcomes of older and younger patients treated with loncastuximab tesirine in the LOTIS-2 clinical trial.
Hamadani, M., Spira, A., Zhou, X., Liao, L., Chen, L., Radford, J., Ai, W., Solh, M., Ardeshna, K., Hess, B., Caimi, P., Stathis, A., Carlo-Stella, C., Alderuccio, J.,...> ;Blood Advances. 2024 Jan 9
10 citations
Amivantamab plus lazertinib in osimertinib-relapsed EGFR-mutant advanced non-small cell lung cancer: a phase 1 trial.
Byoung Chul Cho, Dong-Wan Kim, Alexander I Spira, Jorge E Gomez, Eric B Haura, Sang-We Kim, Rachel E Sanborn, Eun Kyung Cho, Ki Hyeong Lee, Anna Minchom, Jong-Seok Lee...> ;Nature Medicine. 2023 Oct 1
4 citations
Neoadjuvant Durvalumab Alone or Combined with Novel Immuno-Oncology Agents in Resectable Lung Cancer: The Phase II NeoCOAST Platform Trial.
Tina Cascone, Gozde Kar, Jonathan D Spicer, Rosario García-Campelo, Walter Weder, Davey B Daniel, David R Spigel, Maen Hussein, Julien Mazieres, Julio Oliveira, Edwin ...> ;Cancer Discovery. 2023 Nov 1
2 citations
Phase IIa Study of PLX2853 in Gynecologic Cancers With Known ARID1A Mutation and Phase Ib/IIa Study of PLX2853/Carboplatin in Platinum-Resistant Epithelial Ovarian Can...
Linda R Duska, Dmitriy Zamarin, Erica Hamilton, Amit Oza, Gini Fleming, Alexander Spira, Oladapo O Yeku, Debra L Richardson, Jackie Walling, Kerry Inokuchi, Bernice Ma...> ;JCO Precision Oncology. 2023 Sep 1
A plain language summary of the results from the group of patients in the CHRYSALIS study with EGFR exon 20 insertion-mutated non-small-cell lung cancer who received a...
Alexander Spira, Nicolas Girard, Matthew Krebs, Keunchil Park, Catherine Shu, Lindsay Dougherty, Byoung Chul Cho> ;Future Oncology. 2023 Oct 1
1 citations
Pamiparib in combination with tislelizumab in patients with advanced solid tumours: results from the dose-expansion stage of a multicentre, open-label, phase I trial.
Michael Friedlander, Linda Mileshkin, Janine Lombard, Sophia Frentzas, Bo Gao, Michelle Wilson, Tarek Meniawy, Sally Baron-Hay, Karen Briscoe, Nicole McCarthy, Christo...> ;British Journal of Cancer. 2023 Sep 1
5 citations
First-in-Human, Phase I Dose-Escalation and Dose-Expansion Study of Trophoblast Cell-Surface Antigen 2-Directed Antibody-Drug Conjugate Datopotamab Deruxtecan in Non-S...
Toshio Shimizu, Jacob Sands, Kiyotaka Yoh, Alexander Spira, Edward B Garon, Satoru Kitazono, Melissa L Johnson, Funda Meric-Bernstam, Anthony W Tolcher, Noboru Yamamot...> ;Journal of Clinical Oncology. 2023 Oct 10
6 citations
Intracranial Efficacy of Adagrasib in Patients From the KRYSTAL-1 Trial With-Mutated Non-Small-Cell Lung Cancer Who Have Untreated CNS Metastases.
Marcelo V Negrao, Alexander I Spira, Rebecca S Heist, Pasi A Jänne, Jose M Pacheco, Jared Weiss, Shirish M Gadgeel, Karen Velastegui, Wenjing Yang, Hirak Der-Torossian...> ;Journal of Clinical Oncology. 2023 Oct 1
2 citations
Real-world outcomes among patients with EGFR-mutated non-small cell lung cancer treated with EGFR tyrosine kinase inhibitors versus immunotherapy or chemotherapy in th...
Jon Apple, Rahul Shenolikar, Kevin De Silva, Ping Sun, Alexander Spira> ;Cancer Medicine. 2023 Jun 1
2 citations
Early Changes in Circulating Cell-Free KRAS G12C Predict Response to Adagrasib in KRAS Mutant Non-Small Cell Lung Cancer Patients.
Cloud P Paweletz, Grace A Heavey, Yanan Kuang, Emily Durlacher, Thian Kheoh, Richard C Chao, Alexander I Spira, Konstantinos Leventakos, Melissa L Johnson, Sai-Hong Ig...> ;Clinical Cancer Research. 2023 Aug 15
1 citations
Real-world outcomes in patients with KRAS G12C-mutated advanced non-small cell lung cancer treated with docetaxel in second-line or beyond.
Jhanelle E Gray, Hil Hsu, Diana Younan, Gaurav Suri, Victoria Chia, Alexander Spira, Melissa Johnson> ;Lung Cancer. 2023 Jul 1
2 citations
Adagrasib: a novel inhibitor for-mutated non-small-cell lung cancer.
Matthew Z Guo, Kristen A Marrone, Alexander Spira, Samuel Rosner> ;Future Oncology. 2023 May 1
Brief Report: Safety and Antitumor Activity of Durvalumab Plus Tremelimumab in Programmed Cell Death-(Ligand)1-Monotherapy Pretreated, Advanced NSCLC: Results From a P...
Edward B Garon, Alexander I Spira, Sarah B Goldberg, Jamie E Chaft, Vassiliki Papadimitrakopoulou, Tina Cascone, Scott J Antonia, Julie R Brahmer, D Ross Camidge, John...> ;Journal of Thoracic Oncology. 2023 Aug 1
1 citations
Real-world treatment patterns and clinical outcomes for chemotherapy-based regimens in first-line MSI-H/dMMR metastatic colorectal cancer.
Mayur M Amonkar, Monica Chase, Nicole M Myer, Tongtong Wang, Vladimir Turzhitsky, Alexander Spira> ;Cancer Treatment and Research Communications. 2023 Jan 1
19 citations
Adagrasib in Advanced Solid Tumors Harboring aMutation.
Tanios S Bekaii-Saab, Rona Yaeger, Alexander I Spira, Meredith S Pelster, Joshua K Sabari, Navid Hafez, Minal Barve, Karen Velastegui, Xiaohong Yan, Aditya Shetty, Hir...> ;Journal of Clinical Oncology. 2023 Sep 1
4 citations
Practical Guidance for the Management of Adverse Events in Patients with KRASG12C-Mutated Non-Small Cell Lung Cancer Receiving Adagrasib.
Jun Zhang, Melissa Johnson, Minal Barve, Lyudmila Bazhenova, Marybeth McCarthy, Rowena Schwartz, Elise Horvath-Walsh, Karen Velastegui, Chunlin Qian, Alexander Spira> ;The Oncologist. 2023 Apr 6
6 citations
MRTX-500 Phase 2 Trial: Sitravatinib With Nivolumab in Patients With Nonsquamous NSCLC Progressing On or After Checkpoint Inhibitor Therapy or Chemotherapy.
Kai He, David Berz, Shirish M Gadgeel, Wade T Iams, Debora S Bruno, Collin M Blakely, Alexander I Spira, Manish R Patel, David M Waterhouse, Donald A Richards, Anthony...> ;Journal of Thoracic Oncology. 2023 Jul 1
5 citations
Management of infusion-related reactions (IRRs) in patients receiving amivantamab in the CHRYSALIS study.
Keunchil Park, Joshua K Sabari, Eric B Haura, Catherine A Shu, Alexander Spira, Ravi Salgia, Karen L Reckamp, Rachel E Sanborn, Ramaswamy Govindan, Joshua M Bauml, Jos...> ;Lung Cancer. 2023 Apr 1
81 citations
Adagrasib with or without Cetuximab in Colorectal Cancer with MutatedG12C.
Rona Yaeger, Jared Weiss, Meredith S Pelster, Alexander I Spira, Minal Barve, Sai-Hong I Ou, Ticiana A Leal, Tanios S Bekaii-Saab, Cloud P Paweletz, Grace A Heavey, Ja...> ;The New England Journal of Medicine. 2023 Jan 5
Impact of gender and mutational differences in hormone receptor expressing non-small cell lung cancer.
Robert Hsu, Denaly Chen, Bing Xia, Rebecca Feldman, Wendy Cozen, Luis E Raez, Hossein Borghaei, Chul Kim, Misako Nagasaka, Hirva Mamdani, Ari M Vanderwalde, Gilberto L...> ;Frontiers in Oncology. 2023 Jan 1
2 citations
Characterization and management of adverse events observed with mobocertinib (TAK-788) treatment forexon 20 insertion-positive non-small cell lung cancer.
James Chih-Hsin Yang, Caicun Zhou, Pasi A Jänne, Suresh S Ramalingam, Tae Min Kim, Gregory J Riely, Alexander I Spira, Zofia Piotrowska, Tarek Mekhail, Maria Rosario G...> ;Expert Review of Anticancer Therapy. 2023 Jan 1
5 citations
Bintrafusp Alfa: A Bifunctional Fusion Protein Targeting PD-L1 and TGF-β, in Patients with Pretreated Colorectal Cancer: Results from a Phase I Trial.
Alexander Spira, Michael S Wertheim, Edward J Kim, Benjamin Tan, Heinz-Josef Lenz, Petros Nikolinakos, Patricia L Rich, Genevieve Jehl, Andreas Machl, Rena Ito, James ...> ;The Oncologist. 2023 Feb 8
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Journal Articles

Differential Regulation of PD-L1 Expression by Immune and Tumor Cells in NSCLC and the Response to Treatment with Atezolizumab (Anti–PD-L1)
Alan Sandler, David S Shames, Hartmut Koeppen, Jamie Chaft, Scott N Gettinger, Alexander Spira, Daniel S Chen, Naiyer A Rizvi, David R Spigel, Proceedings of the National Academy of Sciences
Brigatinib Versus Crizotinib in ALK-Positive Non–Small-Cell Lung Cancer
D Ross Camidge, Scott N Gettinger, Alexander Spira, The New England Journal of Medicine
Cell-Free DNA NGS Prediction of Response and Resistance to a 3rd-Generation EGFR Inhibitor
Alexander I Spira, Helena A Yu, Clinical Lung Cancer

Abstracts/Posters

Safety, Efficacy and Biomarker Analysis of a Phase 1b/2 Study of Onvansertib (ONV), a Polo-like Kinase 1 (PLK1) Inhibitor, in Combination with Low-Dose Cytarabine (LDA...
Alexander I. Spira, 61st Annual American Society of Hematology Meeting, Orlando, FL, 12/7/2019
Interim Futility Analysis of a Phase 2 Study of Loncastuximab Tesirine, a Novel Pyrrolobenzodiazepine-Based Antibody-Drug Conjugate, in Patients with Relapsed or Refra...
Alexander I. Spira, 61st Annual American Society of Hematology Meeting, Orlando, FL, 12/9/2019

Lectures

The Impact of Immunotherapy on a Community Practice. Integrating Immunotherapy Into Clinical Practice: Changes Over the Past Year (Part 2)
2018 ASCO Annual Meeting - Chicago, Illinois - 05/31/2018

Authored Content

WCLC 2021: Study Improvements Mean Nothing Without PatientsFebruary 2021
Cell-Free DNA NGS Prediction of Response and Resistance to a 3rd-Generation EGFR InhibitorAugust 2018

Press Mentions

First Report of Positive Dose Escalation Data Supports Best-in-Class Profile for Investigational Exarafenib as a Single Agent and in Combination with Binimetinib in BRAF-Altered Cancers and NRAS Mutant MelanomaApril 17th, 2023
Kinnate Biopharma Inc. To Report First Clinical Data for Its Investigational Pan-RAF Inhibitor, Exarafenib (KIN-2787), in an Oral Presentation at the AACR 2023 Annual MeetingMarch 14th, 2023
Janssen Announces New Data Supporting Safety and Efficacy of RYBREVANT and Lazertinib Combination for Patients with Non-Small Cell Lung Cancer and EGFR MutationsJuly 29th, 2022
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