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A Study To Investigate The Safety And Efficacy Of KQB168 As Monotherapy And In Combination In Participants With Advanced Solid Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The goal of this clinical trial is to learn if KQB168 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB168. The main questions it aims to answer are:
* What is the safe dose of KQB168 by itself or in combination with pembrolizumab?
* Does KQB168 alone or in combination with pembrolizumab decrease the size of the tumor?
* What happens to KQB168 in the body?
Participants will:
* Take KQB168 daily, alone or in combination with pembrolizumab
* Visit the clinic about 8 times in the first 8 weeks, and then once every 3 weeks after ...
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Screening and Staging of Benign vs Malignant Pelvic Abnormalities
Rochester, MN
The purpose of this study is to integrate GEHC’s AIR Recon DL (ARDL) technique to current protocols while reducing overall scan time.
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JAB-23E73 In Adult Participants With Advanced Solid Tumors With KRAS Alteration
Rochester, MN
This study is to evaluate the safety and tolerability of JAB-23E73 in adult participants with advanced solid tumors
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A Study of Using Ultrasound to Evaluate Masses in the Liver
Rochester, MN
The purpose of this study is to investigate the value of ultrasound imaging of small blood vessels and tumor stiffness as a new biomarker to characterize the disease and evaluate early treatment for cancer.
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A Study To Provide Expanded Access For The Treatment Of Cancers With Rearranged During Transfection (RET) Activation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to provide expanded access for patients with cancer with RET activation who are ineligible for an ongoing LOXO-292 clinical trial or have other considerations that prevent access to LOXO-292 through an existing clinical trial.
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A Study of Facial Nerve Monitoring During Surgical Removal of the Parotid Gland for Superficial Benign Lesions
Rochester, MN
The purpose of this study is to determine the benefit to postoperative facial nerve function of using electromyography (EMG) based monitoring of facial nerve function during surgery to remove the parotid gland for superficial benign lesions.
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A Phase 1 Study Evaluating The Safety, PK, And Clinical Effects Of PT-112 In Subjects With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose, and evaluate its safety, tolerability, preliminary clinical effects, and drug/body interactions.
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A Study Of The Safety, Effectiveness And Maximum Tolerated Dose Of Oral PQR309 For Patients With Advanced Solid Tumors
Rochester, MN
The purpose of this study is to evaluate the safety, effectiveness and the maximum tolerable dose of PQR309 for the treatment of selected patients who have advanced solid tumors with known activation of AKT/PI3K/mTOR.
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A First-in-Human (FIH) Study To Evaluate The Safety And Tolerability Of VVD-159642 In Participants With Advanced Solid Tumors
Scottsdale/Phoenix, AZ
A FIH study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of VVD-159642, a rat sarcoma viral oncogene-phosphatidylinositol 3-kinase alpha (RAS-PI3Kα) inhibitor, as a single agent and in combination with either sotorasib or trametinib in participants with advanced solid tumors.
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Combination Chemotherapy, Radiation Therapy, and an Autologous Peripheral Blood Stem Cell Transplant in Treating Young Patients with Atypical Teratoid/Rhabdoid Tumor of the Central Nervous System
Rochester, MN
This phase III trial is studying giving combination chemotherapy together with 3-dimensional conformal radiation therapy and an autologous peripheral blood stem cell transplant to see how well it works in treating young patients with atypical teratoid/rhabdoid tumor of the central nervous system. Giving high-dose chemotherapy before an autologous peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy or radiation therapy is then given to prepare ...
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A Study Of NT-175 In Adult Subjects With Unresectable, Advanced, And/or Metastatic Solid Tumors That Are Positive For HLA-A*02:01 And The TP53 R175H Mutation
Jacksonville, FL
Phase I Study of NT-175, an autologous T cell therapy product genetically engineered to express an HLA-A\*02:01-restricted T cell receptor (TCR), targeting TP53 R175H mutant solid tumors.
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Mindfulness-Based Intervention (Muse-S™) as an Adjunct During Diagnostic Work-up in Patients Presenting to the Undiagnosed Mass Clinic (UMC).
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the feasibility of the Mindfulness-Based Intervention Meditation Program to provide an effective and sustainable solution for reducing stress often experienced by patients newly identified as having an unknown mass.
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Evaluate The Safety, Tolerability, Pharmacokinetics And Efficacy Of BL-M05D1 In Subjects With Solid Tumors
Scottsdale/Phoenix, AZ
The objective of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects with Advanced or Metastatic Solid Tumors.
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A Study Of Four-Dimensional MRI For Image-Guided Radiation Therapy
Scottsdale/Phoenix, AZ
The purpose of this study is to develop and evaluate four-dimensional Magnetic Resonance Image (4DMRI) sequence to accurately map tumor motion for radiation treatment.
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A Study of Application of Clonal Analysis to Study Flow Sorted Clinical Samples from Patients with Advanced Solid Tumors
Scottsdale/Phoenix, AZ
This study is being done so researchers can study the genetics of your tumor to better understand how the tumor grows and spreads and collect a blood sample to analyze the genetic material (DNA).
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A Study Of XMT-1660 In Participants With Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to test the safety and side effects of a drug called XMT-1660.
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Outcomes Following Stereotactic Radiosurgery for Patients with Glomus Jugulare Tumors
Rochester, MN
The purpose of this study is to describe long-term hearing outcomes following stereotactic radiosurgery (SRS) for glomus jugulare tumors (GJT).
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A Phase 1 Trial Of MK-4280 As Monotherapy And In Combination With Pembrolizumab With Or Without Chemotherapy Or Lenvatinib (E7080/MK 7902) In Subjects With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a safety and pharmacokinetics study of MK-4280 as monotherapy and in combination with pembrolizumab (MK-3475) in adults with metastatic solid tumors for which there is no available therapy which may convey clinical benefit. Part A of this study is a dose escalation design in which participants receive MK-4280 as monotherapy or MK-4280 in combination with pembrolizumab. Part B is a dose confirmation design to estimate the recommended Phase 2 dose (RPTD) for MK-4280 in combination with pembrolizumab in participants with advanced solid tumors.
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First In Human Study Of TUB-030 In Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The goal of this clinical trial is to learn if the drug TUB-030 works to treat solid cancer in adults. The study will also explore the safety of TUB-030. The main questions it aims to answer are: To determine the safety and tolerability of TUB-030 To determine the maximum tolerated dose of TUB-030 as a single drug given to patients with solid cancer Researchers will also compare doses of TUB-030 in two specific cancer types, in patients with head and neck cancer and patients with non-small cell lung cancer, to see if TUB-030 works to treat these two solid cancer ...
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Intra-Patient Tumor Heterogeneity In Patients With Solid Tumors
Scottsdale/Phoenix, AZ
The purpose of this study is to identify clonal eveolation of tumors by genomically altered DNA sequences resulting from copy number alterations in tumors at initial diagnosis and on recurrence.
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Analysis Of Live Tumor Fragments Of Surgical Resections
Jacksonville, FL
The purpose of this study is to obtain unused resected tumor tissue sample and associated clinical data from patients enrolled in this study to research ex vivo treatment response and integrity of tumor microenvironment using omics analysis and imaging while maintaining cell stability in a live environment.
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A Study of Characteristics and Post-surgical Outcomes of Pediatric Patients Diagnosed with Lipoblastoma
Rochester, MN
The purose of this study is to examine the characteristics and post-surgical outcomes of pediatric patients diagnosed with lipoblastoma.
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A Study Of Entrectinib (RXDX-101) For The Treatment Of Patients With Solid Tumors That Have NTRK1/2/3, ROS1, Or ALK Gene Rearrangements
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the response of entrectinib (RXDX-101) for the treatment of patients with solid tumors that have an NTRK1/2/3, ROS1, or ALK gene rearrangement.
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A Study of AFP464 for Treating Patients with Solid Tumors that are Metastatic or Resistant to Treatment, and Cannot Be Removed By Surgery
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the side effects and best dose of AFP464 for treating patients who have solid tumors that are metastatic or resistant to treatment, and that cannot be removed by surgery. Drugs used in chemotherapy, such as AFP464, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
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Phase 1 Study To Investigate TCRTs KRAS Mutation In Unresectable, Advanced, And/or Metastatic Solid Tumors
Jacksonville, FL
Phase I Study, a master protocol to investigate TCR-Engineered T cells recognizing KRAS mutations in adult subjects with Unresectable, Advanced, and/or Metastatic Solid Tumors.
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A Study Of KK2269 In Adult Participants With Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a first-in-human study of KK2269. Part 1 and Part 2 will be conducted as a multicenter, open-label, non-randomized, dose-escalation study. Participants with advanced or metastatic solid tumors for which no standard therapy is available will be enrolled in Part 1. In Part 1, the primary objective is to assess the safety and tolerability of KK2269.
In Part 2, only participants with gastric adenocarcinoma, GEJ adenocarcinoma, esophageal adenocarcinoma, or NSCLC who have experienced at least one systemic therapy will be enrolled. In Part 2, the primary objective is to assess the safety and tolerability of KK2269 in combination with docetaxel ...
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PTT-936, An Alpha Kinase 1 (ALPK1) Activator, Alone Or In Combination With Anti-PD-1/L1 In Patients With Locally Advanced Or Metastatic Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objective of this study is to evaluate the safety and tolerability of a pharmacologically active dose (PAD) range of PTT-936, which may include identification of the MTD, administered as a single agent in patients with advanced unresectable or metastatic solid tumors who have progressed after exhaustion of standard of care (SOC) or a SOC is not available.
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A Digital Treatment Platform For The Delivery Of Home-Based Sequential Therapy In Patients With Glioma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This clinical trial tests how well a digital treatment platform using a mobile application works for the delivery of home-based sequential therapy in patients with glioma. Access to specialized neuro-oncology care in the United States for patients with glioma is critically deficient. Care at centers with neuro-oncology specialists is associated with improved survival outcomes, yet many patients have limited access due to distance, disease-related disability, or lack of financial resources. The application provides patients continuous access to their care team in the home setting. A digital treatment platform may increase clinical trial participation and accelerate development of novel therapeutics while ...
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SIGMA (Safusidenib In IDH1 Mutant Glioma Maintenance)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a 3-part study. The purpose of Part 1 of the study is to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of safusidenib in participants with recurrent/progressive IDH1-mutant World Health Organization (WHO) Grade 2 or Grade 3 glioma.
The purpose of Part 2 will be to evaluate the efficacy of maintenance safusidenib treatment versus placebo in IDH1-mutant Grade 2 or Grade 3 astrocytoma with high-risk features or IDH1-mutant Grade 4 astrocytoma, following standard-of-care radiation or chemoradiation and adjuvant temozolomide. Part 2 will be randomized, double-blind, and placebo-controlled.
The purpose of Part 3 will be to evaluate the efficacy of safusidenib ...
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Study To Evaluate The Efficacy And Safety Of Ersodetug In Patients With Inadequately Controlled Hypoglycemia Due To Tumor-Associated Hyperinsulinism
Rochester, MN
The objectives of this study are to evaluate the glycemic efficacy, safety, and tolerability of ersodetug as add-on to standard of care (SOC) therapy for treatment of hypoglycemia in participants with inadequately controlled hypoglycemia due to islet-cell (insulinomas) and non-islet cell tumor hyperinsulinism.
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A Study To Evaluate KIN-2787 In Participants With BRAF And/or NRAS Mutation Positive Solid Tumors
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-2787 in adults with BRAF/NRAS-mutated advanced or metastatic solid tumors.
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Prescription of Letrozole for Uterine Myoma
Rochester, MN
The PLUM Study is a randomized, double-blinded, 2-arm, parallel-group, placebo-controlled trial is designed to compare the efficacy of letrozole versus placebo on leiomyoma-related symptoms and quality of life as well as leiomyoma and uterine size.
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Safety And Efficacy Study Of TX103 CAR-T Cell Therapy For Recurrent Or Progressive Grade 4 Glioma.
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a phase I, open-Label, single/multiple dose, dose-escalation study to evaluate the safety, tolerability and antitumor activity of anti-B7-H3 CAR-T cell injection (TX103) in subjects with recurrent or progressive Grade 4 Glioma.The study also plan to explore the Maximum Tolerated Dose (MTD) and determine the Recommended Phase II Dose (RP2D) of the CAR-T cell therapy.
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A Study of GDC-0449 and Erlotinib Hydrochloride, with or without Gemcitabine Hydrochloride for Treating Patients with Metastatic Pancreatic Cancer or Solid Tumors that cannot be Removed by Surgery
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the side effects and best dose of erlotinib hydrochloride when given together with GDC-0449, and either with or without gemcitabine hydrochloride, for the treatment of patients who have metastatic pancreatic cancer or solid tumors that cannot be removed by surgery. Drugs used in chemotherapy, such as GDC-0449 and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving GDC-0449 together with ...
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Rare Cutaneous Tumors and Unresolved Issues with the Current AJCC Cutaneous Carcinoma Staging System
Rochester, MN
Our aim is to study non-melanoma skin cancers (NMSC), rare and adnexal tumor outcomes in the context of the current cutaneous AJCC staging system. We will also examine these rare tumors for other potentially significant factors.
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Circulating Tumor DNA In Endometrial Cancer
Rochester, MN
The goal of this study is to identify circulating tumor DNA in the preoperative blood samples of endometrial cancer patients and detect changes in the quantity and tumor-specific mutations and chromosomal rearrangements in circulating tumor DNA of patients with endometrial cancer.
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Brain Tumor Repository
Scottsdale/Phoenix, AZ
The main objective of the Brain Tumor Repository is to allow access to coded patient data by researchers both inside and outside of the Mayo Clinic system so that important research questions can be answered.
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A Study To Evaluate Regulation Of The Metabolism Of T-Cells By The Tumor Microenvironment In Ovarian Cancer Metastasis
Scottsdale/Phoenix, AZ
The purpose of this study is to analyze how the immune cell repertoire changes during early and late metastasis which could shed light into how the tumor microenvironment in metastatic disease becomes tumor permissive.
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Endoscopic Ultrasound Guided Fine Needle Biopsy (EUS-FNB-SC) Using a Novel Fork Needle
Jacksonville, FL
This is a clinical trial to compare two needles used in biopsy techniques to acquire tissue from pancreatic cancer. The hypothesis is that the tissue yield, as measured by tumor DNA and cellular material is superior for Flexible Needle Biopsy (FNB) compared with conventional Fine Needle Aspiration (FNA). Specifically, FNB will increase the proportion of cases in which sufficient DNA is obtained to allow genomic profiling and whole exome sequencing.
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A Study To Evaluate The Venn Ovarian CAncer Liquid Biopsy
Jacksonville, FL
The primary purpode of this study is to determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the InterVenn Ovarian Cancer Liquid Biopsy among women with ovarian adnexal mass for which a surgery is planned.
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A Study Of Using Proton Beam Therapy Which Spares Mucosal Tissue Following The Removal Of Oropharyngeal Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the clinical outcomes of lower intensity (mucosal tissue sparing) proton beam therapy after the surgical removal of oropharyngeal tumors in cancer patients who have a favorable level of risk.
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A Study Of Binimetinib In Children And Adults With NF1 Plexiform Neurofibromas
Rochester, MN
The purpose of this study is to evaluate children ≥ 1 year of age and adults with neurofibromatosis type 1 (NF1) and plexiform neurofibromas treated with the MEK inhibitor, binimetinib. The primary objective is to determine if there is an adequate level of disease responsiveness to binimetinib in children and adults with NF1 and inoperable plexiform neurofibromas. The objective response to binimetinib is defined as ≥ 20% decrease in tumor volume reduction by 12 courses.
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Expanded Access To Bezuclastinib To Be Coadministered With Sunitinib For Patients With Gastrointestinal Stromal Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this expanded access program (EAP) is to provide investigational bezuclastinib so that it can be coadministered with sunitinib to patients with a diagnosis of gastrointestinal stromal tumors (GIST) with no comparable or satisfactory alternative therapy options. The combination of bezuclastinib and sunitinib provides broad inhibition of all primary and secondary KIT mutations that commonly occur in GIST.
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Temsirolimus and Bevacizumab in Treating Patients with Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer
Rochester, MN; Jacksonville, FL; Scottsdale/Phoenix, AZ
This phase II trial studies how well temsirolimus and bevacizumab work in treating patients with advanced endometrial, ovarian, liver, carcinoid, or islet cell cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of cancer by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab may ...
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A Study To Assess The MEK Inhibitor Mirdametinib (PD-0325901) In Patients With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate PD-0325901 in the treatment of symptomatic inoperable neurofibromatosis type-1 (NF1)-associated plexiform neurofibromas (PNs). All participants will receive PD-0325901.
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Undiagnosed Tumor/Undifferentiated Mass Registry
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to create a research registry to prospectively collect research biospecimens and corresponding clinical data from subjects with an undiagnosed tumor or undifferentiated mass.
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A Study Of Intravital Microscopy (IVM) In Human Solid Tumors
Jacksonville, FL
The purpose of this study is to determine the feasibility of performing HIVM in patients with deep space solid tumors during standard course of surgical resection.
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A Study Of MCLA-128 In Patients With Solid Tumors Harboring An NRG1 Fusion
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety, tolerability, movement (pharmcokinetics, "PK"), biological response (pharmacodynamics, "PD"), ability of the drug to provoke an immune response (immunogenicity) and anti-tumor activity of MCLA-128 in patients with solid tumors harboring an NRG1 fusion.
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A Study Of The Safety And Effectiveness Of HBI-8000 With Nivolumab To Treat Melanoma, Renal Cell Carcinoma And Non-Small Cell Lung Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety, tolerability and effectiveness of HBI-8000 when combined with a standard dose and regimen of nivolumab.
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Study Of TJ011133 In Participants With Relapsed/ Refractory Advanced Solid Tumors And Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and tolerability of TJ011133 in participants with solid tumors and lymphoma.
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The Circulating Cell-free Genome Atlas Study
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
GRAIL is using deep sequencing of circulating cell-free nucleic acids (cfNAs) to develop assays to detect cancer early in blood. The purpose of this study is to collect biological samples from donors with a new diagnosis of cancer (blood and tumor tissue) and from donors who do not have a diagnosis of cancer (blood) in order to characterize the population heterogeneity in cancer and non-cancer subjects and to develop models for distinguishing cancer from non-cancer.