ALERT: COVID19 Update: For your safety, you will be asked to use a mask, if you do not have one, a mask will be provided. If a person presents with a temperature, you will be asked to return home and further instructions will be given by your health care team. For our patient’s protection, no visitors under 18 will be allowed in the offices, there is a limit one (1) visitor per patient if necessary. No visitors are allowed in the chemo infusion room. Telemedicine visits are available for routine office visits.
All Patients – Very Important: Regardless of vaccination status. If you are experiencing a fever or cold-like like symptoms, which also include GI Symptoms and Diarrhea, you should contact your Virginia Cancer Specialists Advice Line before visiting our clinics for scheduled appointments. This includes symptoms of respiratory illness, such as coughing or difficulty breathing. More Information-PLEASE CLICK HERE
Alexander I Spira, MD, PhD, FACP
VCS Physicians
Getting a diagnosis of cancer is the most challenging thing any patient and family will have to go through. My job is to provide the most comprehensive options for patients, with state-of-the-art care and compassion.
Co-Director, VCS Research Institute, Director, Thoracic and Phase I Program, Clinical Assistant Professor, Johns Hopkins
Dr. Alexander Spira earned his medical degree from the New York University School of Medicine. He then went on to complete his internship and residency at the Hospital of the University of Pennsylvania, and his medical oncology fellowship at Johns Hopkins Hospital. During his training, Dr. Spira was granted many awards and honors, and he completed several specialized fellowship programs. Among these honors were the National Institutes of Health Medical Scientist Training Program Fellowship (1990-1997), Merck Corporation Scholarship (1995-1995), Pediatric AIDS Foundation Fellowship (1993- 1995) and Harvard University Scholarship (1987-1990). Dr. Spira has also received his PhD from the New York School of Arts and Sciences.
As Director of the Virginia Cancer Specialists (VCS) Research Institute and the Phase I Trial Program, Dr. Spira is actively involved in advancing medicine and offering targeted treatment options for patients. Although his research interests are numerous, Dr. Spira particularly enjoys studying immunotherapy, personalized medicine, GI, thoracic and lung cancer and sarcomas. Dr. Spira is also Co-Chair of the USOncology Thoracic Oncology Committee, Chair of the USOncology Research Executive Committee, and member of the USOncology National Policy Board Executive Committee. Dr. Spira is a faculty member at Johns Hopkins School of Medicine, and serves as Assistant Professor of Oncology.
Throughout his career, Dr. Spira has been recognized as a Top Doctor in Northern Virginia Magazine and Washingtonian magazine for multiple years. In 2014, he received the prestigious “Castle Connolly America’s Top Doctor” award. In his spare time, Dr. Spira enjoys spending time with his family, coaching children’s sports, cycling, and cheering on his favorite New York sports teams.
Physician Publications
January 29, 2021
Datopotamab deruxtecan and Enhertu show promising early clinical activity in patients with advanced non-small cell lung cancer
More Publications by Alexander I Spira, MD, PhD, FACP
August 11, 2020
Brigatinib Versus Crizotinib in Advanced ALK Inhibitor–Naive ALK-Positive Non–Small Cell Lung Cancer: Second Interim Analysis of the Phase III ALTA-1L Trial
Camidanlumab Tesirine, an Antibody-Drug Conjugate, in Relapsed/Refractory CD25-positive Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia: A Phase I Study
Effect of Doxorubicin Plus Olaratumab vs Doxorubicin Plus Placebo on Survival in Patients With Advanced Soft Tissue SarcomasThe ANNOUNCE Randomized Clinical Trial
Multicenter Phase I Study of Erdafitinib (JNJ-42756493), Oral Pan-Fibroblast Growth Factor Receptor Inhibitor, in Patients with Advanced or Refractory Solid Tumors.
Atezolizumab versus docetaxel for patients with previously treated non-small-cell lung cancer (POPLAR): a multicentre, open-label, phase 2 randomised controlled trial
Efficacy and Safety of Trabectedin or Dacarbazine for Metastatic Liposarcoma or Leiomyosarcoma After Failure of Conventional Chemotherapy: Results of a Phase III Randomized Multicenter Clinical Trial
Randomized Phase II Trial of Erlotinib With and Without Entinostat in Patients With Advanced Non-Small-Cell Lung Cancer Who Progressed on Prior Chemotherapy
Phase II trial of nanoparticle albumin-bound paclitaxel, carboplatin, and bevacizumab in first-line patients with advanced nonsquamous non-small cell lung cancer.
"An Open-Label, Multi-center, Phase I/II Dose Escalation and Expansion Study to Assess
the Safety, Tolerability, Anti-Tumor Activity and Pharmacokinetics of MRG004A in
Patients with Tissue Factor Positive Advanced or Metastatic Solid Tumors"
A Phase 1b/2 Randomized Study of AVB-S6-500 plus Nabpaclitaxel
and Gemcitabine in Patients with Locally Advanced
or Metastatic Pancreatic Adenocarcinoma
A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY EVALUATING THE
SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS,
AND ANTITUMOR ACTIVITY OF PF-07257876 IN PATIENTS WITH ADVANCED
OR METASTATIC TUMORS
A Phase 1b/2, Master Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 510 (pINN Sotorasib) in Subjects with Advanced Solid Tumors with KRAS G12C Mutation **MANY SUBPROTOCOLS FOR THIS TRIAL**
An Open-Label, Phase 1b, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Maximum Tolerated or Administered Dose, Pharmacokinetics, Pharmacodynamics and Efficacy of the Aryl Hydocarbon Receptor Inhibitor (AhRi) BAY 2416964 in Combination with Pembrolizumab in Participants with Advanced Tumors
All Clinical Trials for Alexander I Spira, MD, PhD, FACP
“An Open-Label, Multi-center, Phase I/II Dose Escalation and Expansion Study to Assess
the Safety, Tolerability, Anti-Tumor Activity and Pharmacokinetics of MRG004A in
Patients with Tissue Factor Positive Advanced or Metastatic Solid Tumors”
A Phase 1b/2 Randomized Study of AVB-S6-500 plus Nabpaclitaxel
and Gemcitabine in Patients with Locally Advanced
or Metastatic Pancreatic Adenocarcinoma
A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY EVALUATING THE
SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS,
AND ANTITUMOR ACTIVITY OF PF-07257876 IN PATIENTS WITH ADVANCED
OR METASTATIC TUMORS
A Phase 1b/2, Master Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 510 (pINN Sotorasib) in Subjects with Advanced Solid Tumors with KRAS G12C Mutation **MANY SUBPROTOCOLS FOR THIS TRIAL**
An Open-Label, Phase 1b, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Maximum Tolerated or Administered Dose, Pharmacokinetics, Pharmacodynamics and Efficacy of the Aryl Hydocarbon Receptor Inhibitor (AhRi) BAY 2416964 in Combination with Pembrolizumab in Participants with Advanced Tumors
A First in Human, Phase 1/2 Study of CFI-402411, Hematopoeitic Progenitor Kinase-1 (HPK1) Inhibitor, as a Single Agent and in Combination with Pembrolizumab in Subjects with Advnanced Solid Malignancies
A Phase 1/1b Study to Evaluate the Safety and Activity of TTX-030 (Anti-CD39) in Combination with Pembrolizumab or Budigalimab and/or Chemotherapy in Subjects with Advanced Solid Tumors
A Phase I, Open-Label, Multicenter, First in Human Study of the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of TPX-0022, A Novel MET/CSF1R/SRC Inhibitor, in Patients with Advanced Solid Tumors Harboring Genetic Alterations I MET
Open-Label, Multicenter, First in Human Phase 1/2 Study of RTX-240 for the Treatment of Patients with Relapsed/Refractory or Locally Advanced Solid Tumors
A Phase 1/2a, Open-Label, Mutlicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of PEN-866 in Patients with Advanced Solidy Malignancies
A Phase 1/2, First in Human, Multi-Part, Open-Label, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF6002 as a Monotherapy and in Combination with Nivolumab in Patients with Locally Advanced or Metastatic Solid Tumors
A Phase 1/2 Study of TPX-0046, A Novel Oral RET/SRC Inhibitor in Adult Subjects with Advanced/Metastatic Solid Tumors Harboring Oncogenic RET Fusions or Mutations
A Phase I, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Combinations of ABBV-927 with ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Subjects with Locally Advanced or Metastatic Solid Tumors
A Phase 1/2a, Multi-center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB3312 in Combination with Pembrolizumab or Binimetinib in Adults with Advanced Solid Tumors
A Phase I, Multicenter, Single Agent Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of CPO-100 in Adults with Advanced Solid Tumors
A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2-expressing Tumors
A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Unresectable and or Mets Solid Tumors Harboring HER2 Activating Mutations Regardless of Tumor Histology
A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotorasib in Combination with Everolimus in Subjects with Advanced Solid Tumors with KRAS G12C Mutation
A Phase 1/1b Open-Label, Multicenter, Two-Part Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of KIN-8701 in Subjects with BRAF Mutation Positive Solid Tumors
Phase 1/2, Open-Label, Dose Escalation and Dose Expansion Study of Transcon TLR7/8 Agonist Alone or in Combination with Pembrolizumab in Participants with Locally Advanced or Metastatic Solid Tumor Malignancies
An Open-Label, Multi-Drug, Biomarker-Directed, Multicenter Phase II Umbrella Study in Patients with NSCLC, Who Progressed on and Anti-PD-1/PD-L1 Containing Therapy
Prospective, Interventional Pilot Study of Mobile Devices and Digital Applications to Detect Early Pneumonitis and Other Pulmonary Adverse Events in Unresectable Stage III NSCLC on Durvalumab
A Phase II Study to Evaluate the Safety and Efficacy of AB122 Monotherapy, AB154 in Combination with AB122, and AB154 in Combination with AB122 and AB928 in Front-Line NSCLC
A Phase III, Randomized, Double-Blind Study of BGB-A1217, an Anti-TIGIT Antibody, in Combination with Tislelizumab Compared to Pembrolizumab in Patients with Previously Untreated, PD-L1 Selected, and Locally Advanced, Unresectable or Metastatic NSCLC
A Phase II, Multicenter, Open-Label, Multicohort Study to Assess Safety and Efficacy of CC-90011 in Combination with Nivolumab in Subjects with Advanced Cancers
Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Canakinumab Versus Placebo Versus Placebo as Adjuvant Therapy in Adult Subjects with Stages AJCC/UICC v 8 II-IIIA (T>5cm N2) Completely Resected (R0) NSCLC
Phase III, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study of Durvalumab for the Treatment of Stage II-III NSCLC Patients with Minimal Residual Disease Following Surgery and Curative Intent Therapy.
A Phase III, Randomized, Controlled, Multi-Center, 3 Arm Study of Neoadjuvant Osimertinib as Monotherapy or in Combination with Chemotherapy versus SOC Chemo Alone for the Treatment of Patients with EGFR Positive, Resectable NSCLC
A Phase III, Randomized, Multicenter, Double Blind, Placebo Controlled Study to Determine the Efficacy of Adjuvant Durvalumab in Combination with Platinum-Based Chemotherapy in Completely Resected Stage II-III NSCLC
Randomized, Open-Label Phase II Study of SAR408701 Combined with Pembrolizumab and Pembrolizumab Alone in Patients with CEACAM5 and PD-L1 Positive Advanced/Metastatic Non-Squamous NSCLC.
A Phase Ib Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG510 (pINN Sotorasib) in Combination with Carboplatin and Pemetrexed; with Docetaxel; or with Carboplatin and Paclitaxel in Subjects with Advanced NSCLC with KRAS G12C Mutation
A Phase I Open-Label Study of Patritumab Deruxtecan (U3-1402) in Combination with Osimertinib in Subjects with Locally Advanced or Mets EGFR-Mutated NSCLC
Phase III, Randomized Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib Versus Lazertinib as First-Line Treatment in Paitents with EGFR-Mutated Locally Advanced or Metastatic NSCLC
Phase 1b/2 Study of PLX2853 in Combination with Abiraterone Acetate and Prednisone and Phase 1b/2 Study of PLX2853 in Combination with Olaparib in Subjects with Mets Castration-Resistant Prostate Cancer
A Phase I-II, First in Human Study of SKB264 in Patients with Locally Advanced Unresectable and Metastatic Solid Tumors Who Are Refractory to Available Standard Therapies
A Phase 1b Dose-Escalation Study of the Safety and Pharmacokinetics of Fixed-Dose PCS6422 with Escalating Doses of Capecitabine Administered Orally to Patients with Advanced, Refractory Gastrointestinal Tract Tumors
A Phase 1b Study Evaluating the Safety, Tolerability, and Efficacy of Sotorasib in Combination with Panitumumab and in Combination with Panitumumab and FOLFIRI in Subjects with Advanced Solid Tumors with KRAS G12C
A Phase 1b Study Evaluating the Safety, Tolerability, and Efficacy of Sotorasib in Combination with MVASI and FOLFIRI and in Combination with MVASI and FOLFOX in Subjects with Advanced Colorectal Cancer with KRAS G12C Mutation
A Phase 2, Open-Label Study to Evaluate the Safety and Antitumor Activity of CX-2009 in Advanced HR Positive/HER2 Negative Breast Cancer and of CX2009 as Monotherapy and in Combination with CX-072 for Advanced Triple Negative Breast Cancer
A Phase 2 Randomized Open-Label Study of Patritumab Deruxtecan (U3-1402) in Subjects With Previously Treated Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer
Phase 3 Randomized Study of DS-1062A Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations
Phase 2, Single-arm, Open-label Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations and Progressed on or After Kinase Inhibitor Therapy and Platinum Based Chemotherapy
A Phase 1b/2 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Trastuzumab Deruxtecan (T-DXd) Monotherapy and Combinations in Adult Participants with HER2-Overexpressing Gastric Cancer
A Phase 2 Basket Study of Tucatinib in Combination with Trastuzumab in Subjects with Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors Driven by HER2 Alterations
A Phase 2 Study of VS-6766 (Dual RAF/MEK Inhibitor) as a Single Agent and in Combination with Defactinib (FAK Inhibitor) in Recurrent KRAS-Mutant (KRAS-MT) Non-Small Cell Lung Cancer (NSCLC)
A Phase 1 Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of STRO-002, an anti-Folate Receptor alpha (FolRá) Antibody Drug Conjugate (ADC), in Patients with Advanced Epithelial Ovarian Cancer (including Fallopian Tube or Primary Peritoneal Cancers) and Endometrial Cancers
CX-839-014 “KEAPSAKE”: A Phase 2, Randomized, Multicenter, Double-blind, Study of the Glutaminase Inhibitor Telaglenastat with Pembrolizumab and Chemotherapy versus Placebo with Pembrolizumab and Chemotherapy in First-line Metastatic KEAP1/NRF2-mutated Nonsquamous, Non-Small Cell Lung Cancer (NSCLC)
A Randomized, Open-label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared with Carboplatin-Pemetrexed, in Patients with EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (61186372NSC3001)
A Phase 1/2a, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients with Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations
A Multicenter, Open-Label, Parallel, Phase 2a Study of PLX2853 Monotherapy in Advanced Gynecological Malignancies with a Known ARID1A Mutation and Phase 1b/2a Study of PLX2853/Carboplatin Combination Therapy in Platinum-Resistant Epithelial Ovarian Cancer
An Open-label Phase 1/1b Study to Evaluate the Safety and Pharmacokinetics of JNJ-73841937 (Lazertinib), a Third Generation EGFR-TKI, as Monotherapy or in Combinations With JNJ-61186372, a Human Bispecific EGFR and cMet Antibody in Participants With Advanced Non-Small Cell Lung Cancer
A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients with Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN) (D9106C00001)
Phase III, Open-label, Randomized Study of Osimertinib with or without Platinum Plus Pemetrexed Chemotherapy, as First-line Treatment in Patients with Epidermal Growth Factor Receptor (EGFR) Mutation-Positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLAURA2) (D5169C00001)
Open label, multicenter, multidose, first-in-human Phase 1/2 study of RTX-240 for the treatment of patients with relapsed/refractory or locally advanced solid tumors.
A PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF ATEZOLIZUMAB AND TIRAGOLUMAB COMPARED WITH DURVALUMAB IN PATIENTS WITH LOCALLY ADVANCED, UNRESECTABLE STAGE III NON-SMALL CELL LUNG CANCER WHO HAVE NOT PROGRESSED AFTER CONCURRENT PLATINUM-BASED CHEMORADIATION (SKYSCRAPER-03)
A Phase 1b Efficacy and Safety Study of Cofetuzumab Pelidotin (ABBV-647, a PTK7-Targeting Antibody Drug Conjugate) in Subjects with PTK7-Expressing, Recurrent Non-Small Cell Lung Cancer
A Phase I-II, First-in-Human Study of SKB264 in Patients with Locally Advanced Unresectable /Metastatic Solid Tumors who are refractory to Available Standard Therapies
A PHASE 1/1B MULTICENTER STUDY TO EVALUATE THE HUMANIZED ANTI-CD73 ANTIBODY, CPI-006, AS A SINGLE AGENT OR IN COMBINATION WITH CIFORADENANT, WITH PEMBROLIZUMAB, AND WITH CIFORADENANT PLUS PEMBROLIZUMAB IN ADULT SUBJECTS WITH ADVANCED CANCERS (CPI-006-001)
A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients with Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)
A Phase 1, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of PSB205 in Patients with Relapsed/ Refractory Solid Tumors
A Phase 1b/2a Dose-escalation Study to Assess Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PLX2853 in Subjects with Advanced Malignancies
A Phase 1/2 Study of GRT-C903/GRT-R904, a Vaccine Targeting Shared Neoantigens, in Combination with Immune Checkpoint Blockade for Patients with Advanced Solid Tumors
Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects with Previously Treated c-Met+ Non-Small Cell Lung Cancer
A PHASE I DOSE ESCALATION AND EXPANDED COHORT STUDY OF PF-06821497 IN THE TREATMENT OF ADULT PATIENTS WITH RELAPSED/REFRACTORY SMALL CELL LUNG CANCER (SCLC), CASTRATION RESISTANT PROSTATE CANCER (CRPC) AND FOLLICULAR LYMPHOMA (FL)
A Phase 1/2 Study of Oral LOXO-292 in Patients with Advanced Solid Tumors, Including RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors with RET Activation (LIBRETTO-001
A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of MGC018 (Anti–B7-H3 Antibody Drug Conjugate) Alone and in Combination with MGA012 (Anti–PD-1 Antibody) in Patients with Advanced Solid Tumors
A Phase 1 Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AO-176
An International Phase 1/2 Study of GRT-C901/GRT-R902, a Neoantigen Cancer Vaccine, in Combination with Immune Checkpoint Blockade for Patients with Advanced Solid Tumors
A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-61186372, a Human Bispecific EGFR and cMet Antibody, in Subjects with Advanced Non-Small Cell Lung Cancer
A phase III, multicenter, randomized, double blind, placebo-controlled study evaluating the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) completely resected (R0) non-small cell lung cancer (NSCLC)(CACZ885T2301)
A Phase 1-2, First-in-Human Study of CX-2029 in Adults with Metastatic or Locally Advanced Unresectable Solid Tumors or Diffuse Large B-cell Lymphomas (PROCLAIM-CX-2029)
An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of patients with locally advanced or Metastatic Solid Tumors that Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements.
