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Solid Tumor/Phase I Clinical Trials

Showing 31-60 of 60 items
31.
  • 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 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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  • AZD8186 First Time In Patient Ascending Dose Study
  • This is a phase I, open-label, multicentre study of AZD8186 administered orally in patients with advanced castrate-resistant prostate cancer (CRPC), squamous non-small cell lung cancer (sqNSCLC), triple negative breast cancer (TNBC) and known PTEN-deficient/mutated or PIK3CB mutated/amplified advanced solid malignancies as monotherapy and in combination with abiraterone acetate or AZD2014.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
36.
37.
  • Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
  • A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors to assess the antitumor activity of lurbinectedin (PM01183) in terms of overall response rate (ORR), in the following advanced solid tumors small cell lung cancer (SCLC), head and neck carcinoma (H&N), neuroendocrine tumors (NETs), biliary tract carcinoma, endometrial carcinoma, BRCA 1/2-associated metastatic breast carcinoma, carcinoma of unknown primary site, germ cell tumors (GCTs), and Ewing's family of tumors (EFTs)
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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  • Phase I Dose Escalation Study With an Allosteric AKT 1/2 Inhibitor in Patients
  • This is the first study where BAY1125976 is given to humans. Patients (all comers) will receive the study drug treatment in a dose-escalation scheme (no placebo group) to determine the safety, tolerability and maximum tolerated dose (MTD) of BAY1125976. The relative bioavailability of liquid service formulation and tablets will be determined. After the MTD is defined breast cancer patients with and without AKT1 mutation will be treated. The study will also assess the pharmacokinetics, biomarker status, pharmacodynamic parameters and tumor response of BAY1125976. BAY1125976 will be given daily as single oral application. Treatment will be stopped if the tumor continues to grow, if side effects, which the patient cannot tolerate, occur or if the patient decides to exit treatment.
  • Diagnoses: Breast: Metastatic, Solid Tumor/Phase I
  • Status: Recruiting
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  • A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects With NUT Midline Carcinoma (NMC) and Other Cancers
  • This study is divided into two parts; Part 1 of the study is a dose escalation phase to select the recommended dose for Part 2 based on the safety, pharmacokinetic, and pharmacodynamic profiles observed after oral administration of GSK525762 in the following subjects: NMC, small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), neuroblastoma (NB), castration resistant prostate cancer (CRPC), triple negative breast cancer (TNBC), estrogen receptor positive (ER positive) breast cancer, and MYCN driven solid tumor subjects. Part 2 of the study will explore the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of the recommended dose from Part 1 in cohorts comprised of NMC, small cell lung cancer (SCLC), castration resistant prostate cancer (CRPC), triple negative breast cancer (TNBC), and estrogen receptor positive (ER positive) breast cancer subjects. Approximately 60 subjects will be enrolled in the Part 1 and approximately 150 subjects will be enrolled in Part 2. A sub-study will be opened in Part 1 to approximately 10-12 subjects in the United States to investigate the relative bioavailability of the besylate tablet compared to the amorphous free-base tablet at the maximum tolerated dose (MTD) or recommended phase 2 dosing (RP2D), the effect of high-fat high-calorie meal on the bioavailability of the besylate tablet at the MTD or RP2D and the dose proportionality of two doses of GSK525762 administered as besylate tablet.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
47.
  • Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer
  • The overarching objective of the study is to determine the effectiveness of LMWH/ warfarin vs. DOAC anticoagulation for preventing recurrent VTE in cancer patients. The intervention strategy is Direct Oral AntiCoagulants (DOAC) therapy with edoxaban, apixaban, rivaroxaban, or dabigatran. The comparator is low molecular weight heparin (LMWH) alone or with warfarin. The information gained will empower cancer patients and physicians to make more informed choices about anticoagulation strategies to manage VTE.
  • Diagnoses: Solid Tumor/Phase I, Multiple Myeloma, Lymphoma
  • Status: Recruiting
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  • Study of Orally Administered AG-120 in Subjects With Advanced Solid Tumors, Including Glioma, With an IDH1 Mutation
  • The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced solid tumors, including glioma, that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-120 to determine maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is a dose expansion phase where four arms of patients will receive AG-120 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. Anticipated time on study treatment is until disease progression, unacceptable toxicity occurs or at Investigator discretion.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
52.
  • GSK3174998 Alone or With Pembrolizumab in Subjects With Advanced Solid Tumors (ENGAGE-1)
  • This is a first time in human (FTIH), open-label, non-randomized, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary clinical activity of GSK3174998 administered intravenously to subjects with selected advanced or recurrent solid tumors. This dose-escalation study will assess the safety, activity of GSK3174998 as monotherapy (Part 1), in combination with pembrolizumab (Part 2), and potentially in combination with additional therapies. The study will be conducted in 2 parts, each part consisting of a dose-escalation phase followed by a cohort expansion phase. Part 1 will evaluate GSK3174998 monotherapy, while Part 2 will evaluate GSK3174998 in combination with pembrolizumab. GSK3174998 will first be evaluated as monotherapy in escalating doses. Once a dose of GSK3174998 has been identified that is both tolerable and demonstrates pharmacodynamic activity, enrollment of Part 2 may begin. In Part 2, escalating doses of GSK3174998 will be evaluated with fixed doses of pembrolizumab. The study will enroll up to approximately 180 subjects with different tumor types (approximately 60 subjects in Parts 1A and 2A [dose escalation]; approximately 120 subjects in Parts 1B and 2B [cohort expansion]). The maximum duration of treatment with GSK3174998 will be 48 weeks; the maximum duration of treatment with pembrolizumab will be 2 years. The follow-up period for safety assessments will be a minimum of 3 months from the date of the last dose. The post-treatment follow-up period includes disease assessments every 12 weeks.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
53.
  • A Study of RO6958688 in Patients With Locally Advanced and/or Metastatic Solid Tumors
  • This study is a first-in-human, open-label, multi-center, dose-escalation Phase 1 clinical study of single-agent RO6958688 in patients with locally advanced and/or metastatic CEA-positive solid tumors who have progressed on standard treatment, are intolerant to standard of care (SOC), and/or are non-amenable to SOC. The study will be conducted in two parts. Part 1 will investigate the safety and pharmacokinetics of a single dose of RO6958688 in single patient cohorts. Part 2 will establish the appropriate therapeutic dose(s) based on safety, pharmacokinetics, and the maximum tolerated dose of RO6958688 for the weekly schedule. The anticipated time on treatment is a maximum of 24 months. The overall target sample size is 90.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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  • A Phase I, Open-Label Study of MOXR0916 in Patients With Locally Advanced or Metastatic Solid Tumors
  • This is a first-in-human, Phase I, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, and pharmacokinetics of MOXR0916 administered intravenously in patients with locally advanced or metastatic solid tumors that have progressed after all available standard therapy or for which standard therapy has proven to be ineffective or intolerable, or is considered inappropriate. The planned duration of the study is approximately 3 years.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
58.
  • A Study of RO5509554 and MPDL3280A Administered in Combination in Patients With Advanced Solid Tumors
  • This Phase 1, open-label, multicenter, global study will evaluate the safety, pharmacokinetics, and activity of RO5509554 and MPDL3280A administered in combination in patients with selected locally advanced or metastatic solid tumors that are not amenable to standard treatment. Patients who receive MPDL3280A and RO5509554 will continue to receive study drug as long as they experience clinical benefit in the opinion of the investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data, biopsy results (if available), and clinical status, or withdrawal of consent.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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Showing 31-60 of 60 items
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