Clinical Trials

Clinical trials are how new treatments and improved outcomes are developed in health care. Highlands Oncology has been participating in clinical trials for over 26 years. Our Research Department operates numerous clinical trials in both oncology and hematology. New experimental medications, or different ways to use existing medications, are compared to the currently available treatments in order to advance cancer care for patients around the world.

Each clinical trial has certain criteria that must be met to participate. These guidelines help protect the safety of each patient. There are four phases of clinical trial development:

  • Phase I – Assessing medication dose and safety
  • Phase II – Further assessing safety and efficacy
  • Phase III – Comparison to currently available medications
  • Phase IV – Further study of already FDA-approved medications

Phase I clinical trials provide new, novel approaches for the treatment of cancer. Highlands Oncology has the privilege of being the only community based Phase I oncology clinical trial center in the state of Arkansas. Cancer research is always evolving and new treatments emerge every year. Highlands Oncology stays at the cutting edge of technology with help from the Research Department and clinical trials.

We strive to provide as many options as possible for the treatment of cancer. Only you and your doctor can decide if a clinical trial is right for you. If you are interested in participating in a clinical trial, please review our list of currently enrolling clinical trials. For further information on clinical trials, please visit http://www.clinicaltrials.gov.

For questions or more information, please contact the Research Department:

  • By email: research@hogonc.com
  • By phone: 479-872-8130
  • Contact Highlands Oncology: 479-587-1700

 

Stemline STML-ELA-0222 – A Phase 1b/2, Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer BREAST 07/27/2023 View Here
Stemline STML-ELA-0322 – ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer: An Open-Label Multicenter Phase 2 Study (ELCIN) BREAST 07/26/2023 View Here
AstraZeneca D926NC00001 Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Durvalumab and Carboplatin for First-Line Treatment of Patients With Advanced NSCLC Without Actionable Genomic Alterations (AVANZAR) LUNG – Non Small Cell Cancer (NSCLC) 05/25/2023 View Here
AstraZeneca D926XC00001 – A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (DatoDXd) With or Without Durvalumab Versus Investigator’s Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPION-Breast03) BREAST 02/15/2023 View Here
Arvinas ARV-471-BC-201:
This is a Phase 2, open-label, randomized, non-comparative proof of concept study of ARV-471 or anastrozole in participants with ER+/HER2- breast cancer amenable to definitive surgical resection. The main goal of this study is to evaluate the biological activity of ARV-471 and anastrozole, respectively.
BREAST 02/15/2023 View Here
Merck MK1026-003: A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants With Hematologic Malignancies OTHER 02/02/2023 View Here
AstraZeneca D967RC00001: A Phase 3 Open-label Trial of Neoadjuvant Trastuzumab Deruxtecan (T-DXd) Monotherapy or T-DXd Followed by THP Compared to ddAC-THP in Participants With High-risk HER2-positive Early-stage Breast Cancer (DESTINY-Breast11) BREAST 01/26/2023 View Here
Daiichi Sankyo DS7300-127: A Phase 2, Multicenter, Randomized, Open-label Study of DS-7300a, a B7-H3 Antibody Drug Conjugate (ADC), in Subjects With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) LUNG 01/11/2023 View Here
Imugene CF33-hNIS-002: This is an open-label, dose-escalation, multi-center phase I study evaluating the safety of CF33-hNIS (hNIS – human sodium iodide symporter) administered via two routes of administration, intratumoral (IT) or intravenous (IV), either as a monotherapy or in combination with pembrolizumab in patients with metastatic or advanced solid tumors. Solid Tumors 01/05/2023 View Here
Freenome FRNM-008: The Vallania Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening OTHER 12/27/2022 View Here
Shanghai Henlius Biotech HLX10-005-SCLC301-E: A PHASE 1A/B OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH ADVANCED SOLID TUMORS LUNG – Small Cell Cancer (SCLC) 12/12/2022 View Here
Eli Lilly J2J-MC-JZLH: EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients Who Have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer With an Increased Risk of Recurrence BREAST 11/22/2022 View Here
Pfizer C4901001: A PHASE 1A/B OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH ADVANCED SOLID TUMORS Solid Tumors 11/11/2022 View Here
OncoC4 ONC-392-001: Safety, Pharmacokinetics (PK), and Efficacy of ONC-392 as a Single Agent and in Combination With Pembrolizumab in Advanced Solid Tumors and NSCLC: An Open Label Phase IA/IB Study. Preserve CTLA4 Checkpoint Function (PRESERVE-001) OTHER 10/28/2022 View Here
Revolution Medicines RMC-6291-001: Phase 1/1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors LUNG – Non Small Cell Cancer (NSCLC) 10/24/2022 View Here
Bristol-Myers Squibb CA027-002: A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers MELANOMA 10/24/2022 View Here
Sarah Cannon BRE-354: A Phase II Study of U3-1402 in Patients With Metastatic Breast Cancer BREAST 10/21/2022 View Here
Seagen Inc., SGN35-033: A Phase 2 Study of Brentuximab Vedotin in Combination With Pembrolizumab in Subjects With Metastatic Solid Malignancies After Progression on Prior PD-1 Inhibitor Treatment MELANOMA 10/17/2022 View Here
Ascentage Pharma APG-5918XG101:
A Phase I Study of Safety, Pharmacokinetic and Efficacy of Orally Administered APG-5918 in Patients With Advanced Solid Tumors or Hematologic Malignancies
OTHER 10/13/2022 View Here
EQRx International EQ 143-301: A Randomized, Three-Arm, Open-Label Phase 3b Clinical Trial of Aumolertinib, Versus Aumolertinib With Chemotherapy, Versus Osimertinib for Patients With Metastatic NSCLC and an EGFR Mutation LUNG – Non Small Cell Cancer (NSCLC) 08/09/2022 View Here
Guardant 02-MX-002 SHIELD – Screening for High Frequency Malignant Disease (SHIELD) LUNG 08/08/2022 View Here
iTEOS A2A-005: Study of Inupadenant (EOS100850) With Chemotherapy as Second Line Treatment for Nonsquamous Non-small Cell Lung Cancer LUNG – Non Small Cell Cancer (NSCLC) 08/08/2022 View Here
Eli Lilly I3Y-MC-JPEG: CYCLONE 3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination With Abiraterone Plus Prednisone in Men With High-Risk Metastatic Hormone-Sensitive Prostate Cancer PROSTATE 07/26/2022 View Here
Novartis CLEE011A2412B: A Post-trial Access Roll-over Study to Allow Access to Ribociclib (LEE011) for Patients Who Are on Ribociclib Treatment in Novartis-sponsored Study BREAST 07/07/2022 View Here
Daiichi Sankyo: U31402-A-U301- A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy LUNG – Non Small Cell Cancer (NSCLC) 06/08/2022 View Here
Takeda TAK573-1501: A Phase 1/2 Open-label Study to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of Modakafusp Alfa (TAK-573) as a Single Agent in Patients With Relapsed Refractory Multiple Myeloma MULTIPLE MYELOMA 06/03/2022 View Here
Bristol-Myers Squibb: CA224-123 – A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal Cancer (RELATIVITY-123) COLORECTAL 06/03/2022 View Here
Pfizer C4761001- A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI TUMOR ACTIVITY OF PF-07799933 (ARRY-440) AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 16 YEARS AND OLDER WITH ADVANCED SOLID TUMORS WITH BRAF ALTERATIONS MELANOMA 05/26/2022 View Here
Pfizer: C4201002 – A PHASE 1, OPEN-LABEL, MULTI-CENTER, DOSE-FINDING, PHARMACOKINETIC, SAFETY AND TOLERABILITY STUDY OF PF 07265807 IN PARTICIPANTS WITH SELECTED ADVANCED OR METASTATIC SOLID TUMOR MALIGNANCIES. Solid Tumors 05/19/2022 View Here
Navire Pharma Inc., Nav-1004: A Phase 1 Study of the SHP2 Inhibitor BBP-398 (Formerly Known as IACS-15509) in Combination With the Programmed Death Receptor-1 Blocking Antibody Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer With a KRAS Mutation LUNG – Non Small Cell Cancer (NSCLC) 05/16/2022 View Here
Gritstone Bio, Inc. GO-010: A Study of a Personalized Neoantigen Vaccine in Combination With Immune Checkpoint Blockade for Patients With Metastatic Colorectal Cancer. COLORECTAL 04/18/2022 View Here
Eli Lilly I3Y-MC-JPEF: A Phase 3: Randomized, Double Blind: Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Advanced or Metastatic Breast, HR+, HER2-, following progression on a CDK 4/6 Inhibitor and Endocrine Therapy. BREAST 01/10/2022 View Here
AstraZeneca D967UC00001: Phase III Study of Trastuzumab Deruxtecan (T-DXd) with or without Pertuzumab versus Taxane, Trastuzumab and Pertuzumab in HER2-positive, First-line Metastatic Breast Cancer (DESTINY-Breast09) BREAST 01/03/2022 View Here
AstraZeneca D8532C00001 (SERENA-4): A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease. BREAST 12/06/2021 View Here
Mirati Therapeutics Inc. 849-007: Phase 2 Trial of MRTX849 Monotherapy and in Combination With Pembrolizumab for NSCLC With KRAS G12C Mutation KRYSTAL-7. LUNG – Non Small Cell Cancer (NSCLC) 11/02/2021 View Here
Pfizer C4401001: A Study to Test the Safety and Tolerability of PF-07257876 in Participants With Selected Advanced Tumors. Solid Tumors 09/30/2021 View Here
Seattle Genetics SGNS40-002: An Open-label, Phase 2 Basket Study of SEA-CD40 Combination Therapies in Subjects with Advance Malignancies OTHER 09/16/2021 View Here
Immunomedics IMMU-132-11: A Phase 2 Open-Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects with Metastatic Solid Tumors Solid Tumors 06/16/2021 View Here
Vaccinex VX15/2503-12: A Phase 1b/2 Study of the Combination of Pepinemab and Pembrolizumab in Patients with Advanced, Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck. HEAD/NECK 04/29/2021 View Here
TG Therapeutics TG-1801-102: “A Phase 1b Multi-cohort Study of TG-1801 Alone or in Combination with Ublituximab in Subjects with B-Cell Lymphoma or Chronic Lymphocytic Leukemia” LEUKEMIA – Chronic Lymphocytic 04/07/2021 View Here
Hutchison 2020-013-00US3: An Open-Label, Phase 1b/2 Study to Evaluate the Safety and Efficacy of Fruquintinib in Combination With Tislelizumab in Patients With Advanced Solid Tumors OTHER 03/26/2021 View Here
Mirati Therapeutics 849-010: A Randomized Phase 3 Study of MRTX849 in Combination with Cetuximab Versus Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation with Disease Progression On or After Standard First-Line Therapy COLORECTAL 03/15/2021 View Here
AbbVie M20-124: A Phase 1, Multi-center, Open Label First-in-Human Study with ABBV-CLS-579 Alone and in Combination with Anti-PD-1 in Subjects with Locally Advanced or Metastatic Tumors Solid Tumors 03/01/2021 View Here
Abbvie M20-178: A Study of Oral Navitoclax Tablet in Combination With Oral Ruxolitinib Tablet to Assess Change in Spleen Volume in Adult Participants With Relapsed/Refractory Myelofibrosis (TRANSFORM-2). Myelofibrosis 10/02/2020 View Here
AbbVie M19-037:
A Phase 1, 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
OTHER 07/14/2020 View Here
Ultimovacs UV1-202:
A Randomized Phase II, Open-Label, Active-Controlled, Multicenter Study Investigating the Efficacy and Safety of UV1 Vaccination in Combination with Nivolumab and Ipilimumab as First-Line Treatment of Patients with Unresectable or Metastatic Melanoma
MELANOMA 05/28/2020 View Here
AbbVie M14-239:
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
LUNG – Non Small Cell Cancer (NSCLC) 03/11/2020 View Here
AbbVie M16-573: A Phase I First-in-Human Study with ABBV-155 Alone and in Combination with Taxane
Therapy in Adults with Relapsed and/or Refractory Solid Tumors
OTHER 02/06/2020 View Here
Ascentage Pharma APG-115-US-002: A Phase Ib/II Study of APG-115 in Combination with Pembrolizumab in Patients with Unresectable or Metastatic Melanomas or Advanced Solid Tumors OTHER 09/10/2019 View Here
Southwest Oncology Group (SWOG) S1609: DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors OTHER 04/10/2018 View Here