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Solid Tumor/Phase I Clinical Trials

Showing 1-30 of 61 items
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  • A Study to Investigate the Safety and Efficacy of Nivolumab and Nivolumab Plus Ipilimumab in Virus-associated Tumors
  • The purpose of this study to investigate the safety and efficacy of using nivolumab, and nivolumab in combination with ipilimumab, to treat subjects who have virus-associated tumors. Certain viruses that infect human cells have been known to play a role in tumor formation and growth. This study will investigate the effects of the study drugs nivolumab, and nivolumab in combination with ipilimumab, in human subjects who have the following types of tumors: Epstein Barr Virus (EBV) positive gastric cancer; EBV positive nasopharyngeal cancer (NPC); Human Papilloma Virus (HPV) positive cervical, vaginal, vulvar cancer; HPV positive squamous cell cancer of the head and neck (SCCHN); and Polyomavirus positive merkel cell cancer.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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  • Safety Study of MGA271 in Refractory Cancer
  • The purpose of this study is to evaluate the safety of MGA271 when given by intravenous (IV) infusion to patients with refractory cancer. The study will also evaluate how long MGA271 stays in the blood and how long it takes for it to leave the body, what is the highest dose that can safely be given, and whether it may have an effect on tumors.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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  • A Study Of PF-05212384 In Combination With Other Anti-Tumor Agents
  • This study will evaluate PF-05212384 (PI3K/mTOR inhibitor) in combination with either docetaxel, cisplatin or dacomitinib in select advanced solid tumors. The study will assess the safety, pharmacokinetics and pharmacodynamics of these combinations in patients with advanced cancer in order to determine the maximum tolerated dose in each combination.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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  • A Two Part, Multicenter, Open-label Study of TEN-010 Given Subcutaneously
  • TEN-010 is a small molecule, bromodomain and extra-terminal domain (BET) bromodomain inhibitor. This study is designed to characterize the safety, tolerability, pharmacokinetics and anti-tumor activity of TEN-010 in patients who are refractory or intolerant to standard/approved therapies. This first-in-human study of TEN-010 will be conducted in two parts: dose escalation and dose expansion. For dose escalation (Part A), a standard "3+3" design will be used in which successive cohorts of three or more patients with advanced solid tumor malignancies will be treated at escalating doses until a maximum tolerated dose (MTD) is identified. For the dose expansion part of the study (Part B), a subset of patients with advanced solid malignancies will be treated with TEN-010 at the MTD (or the highest dose tested if the MTD is not defined) to further characterize safety and biological effect. In addition, up to 10 patients with nuclear protein in testis (NUT) midline carcinoma (NMC) will be permitted to enroll in a substudy of the protocol. This is a Phase 1 non-randomized, dose-escalating, open label, multi-center study to be conducted in two parts (Part A and Part B). A maximum of 56 patients aged 18 years or older with histologically confirmed advanced solid tumors with progressive disease requiring therapy will be enrolled in the study. It is expected that approximately 36 patients will be enrolled in 6 cohorts of up to 6 patients per cohort in Part A of the study and 20 additional patients will be enrolled in Part B of the study. Up to 10 patients with NMC may be enrolled as part of a substudy within the protocol.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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  • A Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors
  • The primary objective of this study is to determine the maximum tolerated dose (MTD) or recommended phase II doses of sapacitabine and seliciclib administered sequentially or concomitantly. The secondary objectives are to evaluate antitumor activity of this sequential or concomitant treatment and to explore the pharmacodynamic effect of this treatment in skin and peripheral blood mononuclear cells.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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  • Veliparib and Dinaciclib in Treating Patients With Advanced Solid Tumors
  • This phase I trial studies the side effects and the best dose of veliparib and dinaciclib in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment. Veliparib and dinaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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  • Study of the Glutaminase Inhibitor CB-839 in Solid Tumors
  • Many tumor cells, in contrast to normal cells, have been shown to require the amino acid glutamine to produce energy for growth and survival. To exploit the dependence of tumors on glutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamine utilization, glutaminase, will be tested in this Phase 1 study in patients with solid tumors. This study is an open-label Phase 1 evaluation of CB-839 in patients with advanced solid tumors. The study will be conducted in 2 parts. Part 1 is a dose escalation study enrolling patients with locally-advanced, metastatic and/or refractory solid tumors to receive CB-839 capsules orally twice or three times daily. In Part 2, patients with each of the following diseases will be enrolled: A) Triple-Negative Breast Cancer, B) Non-Small Cell Lung Cancer (adenocarcinoma), C) Renal Cell Cancer, D) Mesothelioma, E) Fumarate hydratase (FH)-deficient tumors, F) Succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumors (GIST), G) SDH-deficient non-GIST tumors, H) tumors harboring mutations in isocitrate dehydrogenase-1 (IDH1) or IDH2, and I) cMyc mutation tumors. As an extension of Parts 1 & 2, patients will be treated with CB-839 in combination with standard chemotherapy. Combination groups include: Pac-CB, CBE, CB-Erl, CBD, and CB-Cabo. Pac-CB: patients with locally-advanced or metastatic TNBC will be treated with paclitaxel and CB-839. CBE: patients with advanced clear cell RCC or papillary RCC will be treated with everolimus in combination with CB-839. CB-Erl: patients with advanced NSCLC lacking the T790M EGFR mutation will be treated with erlotinib and CB-839. CBD: patients with NSCLC harboring KRAS mutation will be treated with docetaxel and CB-839. CB-Cabo: patients with histologically confirmed diagnosis of locally-advanced, inoperable or metastatic RCC treated with cabozantinib in combination with CB-839. All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug), pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that may predict responsiveness in later studies), and tumor response.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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  • Debio 1347-101 Phase I Trial in Advanced Solid Tumours With Fibroblast Growth Factor Receptor (FGFR) Alterations
  • This study is primarily designed to assess the safety and the tolerability of Debio1347 (CH5183284) in patients with advanced solid malignancies, whose tumours have an alteration of the Fibroblast Growth Factor Receptor (FGFR) 1, 2 or 3 genes, for whom standard treatment does not exist or is not indicated. The main objective of Part A is to identify the dose-limiting toxicities (DLTs) and estimate the maximum tolerated dose (MTD) based on the safety and tolerability of Debio1347 orally administered daily to these patients, in order to determine the recommended dose. The main objective of Part B is to evaluate the safety profile at the recommended dose, in a larger cohort of these patients.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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  • Pembrolizumab and Ziv-aflibercept in Treating Patients With Advanced Solid Tumors
  • This phase I trial studies the side effects and best dose of ziv-aflibercept when given together with pembrolizumab in treating patients with solid tumors that have spread to other places in the body. Ziv-afibercept works by decreasing blood and nutrient supply to the tumor, which may result in shrinking the tumor. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Giving ziv-aflibercept together with pembrolizumab may be a better treatment for patients with advanced solid tumors.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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Showing 1-30 of 61 items
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