CLINICAL TRIALS
CLINICAL TRIALS
Our partnership with OneOncology provides us access to the OneOncology Research Network (OneR), a national site management organization that brings operational expertise and centralized services to efficiently deliver multi-center clinical research across our growing network of oncology practices.
Since clinical trials are increasingly integral to the standard of care for precision oncology, the OneR platform expands patients’ access to more innovative therapies. At the same time, OneR provides clinical trial sponsors access to the large and diverse populations of patients who are treated in community centers throughout their cancer journey, and not episodic as is more common in research-based academic centers. With a majority of cancer care being delivered in community-based centers, OneR ensures diversity in clinical trial participation including ethnicity, gender, geography, disease status, socioeconomics and various other dimensions.
Solid Tumor Trials
| Sponsor | Phase | Line of Tx | NCT # | PI Name | Protocol Title |
|---|---|---|---|---|---|
| KLUS_PPD | Phase I | Solid Tumor | NCT04152499 | Lasika Seneviratne, MD | 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 |
| AstraZeneca | Phase II | Metastatic Gastric/ Gastroesophageal Junction Adenocarcinoma | Sungwon R. Kyung, MD | A Master Protocol of an Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Novel Combinations in Participants with Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (GEMINI- D7986C00001) |
Lung Cancer Trials
| Sponsor | Phase | Line of Tx | NCT # | PI Name | Protocol Title |
|---|---|---|---|---|---|
| AstraZeneca | Phase III | 2L & 3L NSCLC | NCT#05450692 | Lasika Seneviratne, MD | A Phase III, Open-label, Randomised, Multicentre Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations, and Whose Disease Has Progressed On or After Prior Anti-PD-(L)1 Therapy and Platinum-based Chemotherapy: LATIFY |
| AstraZeneca | Phase III | 1L NSCLC | NCT#NCT05687266 | Lasika Seneviratne, MD | A Phase III, Randomised, Open-label, Multicentre, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination with Durvalumab and Carboplatin Versus Pembrolizumab in Combination with Platinum-based Chemotherapy for the First-line Treatment of Patients with Locally Advanced or Metastatic NSCLC without Actionable Genomic Alterations: AVANZAR |
| GSK 213284 | Phase II | Adjuvant & 1L NSCLC | NCT03735121 | Lasika Seneviratne, MD | A RANDOMIZED, MULTICENTER, OPEN-LABEL CROSS-OVER STUDY TO EVALUATE PARTICIPANT AND HEALTHCARE PROFESSIONAL REPORTED PREFERENCE FOR SUBCUTANEOUS ATEZOLIZUMAB COMPARED WITH INTRAVENOUS ATEZOLIZUMAB FORMULATION IN PARTICIPANTS WITH NONSMALL CELL LUNG CANCER” |
Breast Cancer Trials
| Sponsor | Phase | Line of Tx | NCT # | PI Name | Protocol Title |
|---|---|---|---|---|---|
| AstraZeneca | Phase III | 1L TNBC (no PD-L1 therapy candidate) | NCT#05460273 | Lasika Seneviratne, MD | A Phase 3, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) Versus Investigator’s Choice of Chemotherapy in Patients who are not Candidates for PD-1/PD-L1 Inhibitor Therapy in First-line Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast02) |
| Genetech_Roche | Phase III | 1L HER2 (+) mBC | NCT#05296798 | Lasika Seneviratne, MD | A phase III, randomized, open-label study evaluating the efficacy and safety of Giredestrant in Combination with phesgo versus phesgo after induction Therapy with Phesgo+taxane in patients with previously untreated her2-positive, estrogen receptor-positive locally-advanced or metastatic breast Cancer WO43571 |
| AstraZeneca | Phase III | Neo Adjuvant HER2(+) BC | NCT#05113251 | Kristina Larson,MD | 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-rosk HER2-positive Early-stage Breast Cancer(DESTINY-Breast11) |
| Genetech_Roche | Phase III | 2L HER 2(-) mBC | NCT# 05306340 | Lasika Seneviratne, MD | A Phase III, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus everolimus compared with exemestane plus everolimus in patients with ER-positive, HER2-negative locally advanced (recurrent or progressed) or metastatic breast cancer who have had previous treatment with CDK4/6 inhibitors (CDK4/6is) and endocrine therapy (ET). ML43171 |
| ROCHE WO43919/ | Phase III | PIK3CA HR+, HER2- Mbc | Lasika Seneviratne, MD | A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Gdc-0077 Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients with Pik3ca-Mutant, Hormone Receptor- Positive, Her2-Negative Locally Advanced or Metastatic Breast Cancer | |
| Gilead | Phase III | TNBC Adjuvant Study | NCT#05633654 | Lasika Seneviratne, MD | A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician’s Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy-ASCENT-05 |
| Gilead_Ascent07 | Phase III | HR+, HER2-, 1 L aBC/mBC | Lasika Seneviratne, MD | A Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2-Negative (HER2−) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH−]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy | |
| AstraZeneca | Phase III | Adjuvant TNBC | NCT05629585 | Lasika Seneviratne, MD | A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) 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 Breast 03 |
Colorectal Cancer Trials
| Sponsor | Phase | Line of Tx | NCT # | PI Name | Protocol Title |
|---|---|---|---|---|---|
| SEAGEN | Phase III | 1L HER2(+) CRC | NCT#05253651 | Sungwon R. Kyung, MD | An Open-label Randomized Phase 3 Study of Tucatinib in Combination with Trastuzumab and mFOLFOX6 versus mFOLFOX6 given with or without either Cetuximab or Bevacizumab as First-line Treatment for Subjects with HER2+ Metastatic Colorectal Cancer |
R/R Multiple Myeloma Trials
| Sponsor | Phase | Line of Tx | NCT # | PI Name | Protocol Title |
|---|---|---|---|---|---|
| EMN 29 | Phase II | R/R MM | NCT# 05028348 | Lasika Seneviratne, MD | A Phase III Randomized, open-label trial of SELINEXOR, POMALIDOMIDE, AND DEXAMETHASONE (SPd) VERSUS ELOTUZUMAB, POMALIDOMIDE, AND DEXAMETHASONE (EloPd) in patients with relapsed or Refractory Multiple Myeloma(RRMM). |
Lymphoid Malignancies Trials
| Sponsor | Phase | Line of Tx | NCT # | PI Name | Protocol Title |
|---|---|---|---|---|---|
| AVM | Phase II | R/R B cell Malignancies | NCT#04329728 | Lasika Seneviratne, MD | An Open-Label, Phase 1/2 Study Evaluating AVM0703 in Patients with Lymphoid Malignancies (WWRD Study) |
