Solid Tumor/Phase I Clinical Trials

Showing 31-48 of 48 items
31.
  • 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 advanced solid malignancies. The study design allows an escalation of dose with intensive safety monitoring to ensure the safety of the patients. There are two parts to this study: Part A, dose escalation, and Part B, expansion cohort(s) at the intended therapeutic dose(s).
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
32.
  • A Study Evaluating the Safety of Escalating Doses of DLYE5953A in Patients With Refractory Solid Tumors
  • This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and PK of escalating doses of DLYE5953A administered to patients with incurable, locally advanced, or metastatic solid malignancy that has progressed on standard therapy. The Phase I study consists of two stages: Stage 1 dose-escalation and Stage 2 expansion in selected patients. In Stage 1, a 3 + 3 dose-escalation design will be used to examine the safety, tolerability, and PK of increasing doses of DLYE5953A. In Stage 2, patients will be enrolled to further characterize the safety, tolerability, and PK of the proposed dose and schedule for future studies.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
33.
  • 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 of GDC-0575 Alone And in Combination With Gemcitabine in Patients With Refractory Solid Tumors or Lymphoma
  • This open-label, multicenter, Phase I, dose-escalation study will evaluate the s afety, tolerability and pharmacokinetics of GDC-0575 administered alone or in co mbination with gemcitabine in patients with refractory solid tumors or lymphoma. In Stage I, cohorts of patients will receive multiple ascending oral doses of G DC-0575 alone (Arm 1) or in combination with intravenous gemcitabine (Arm 2). In Stage II, patients will receive GDC-0575 orally in combination with intravenous gemcitabine at or below the maximum tolerated dose determined in Stage I. Antic ipated time on study treatment is until disease progression or unacceptable toxi city occurs, for a maximum of 17 cycles (approximately 1 year).
  • Diagnoses: Solid Tumor/Phase I
  • 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 three cohorts of patients will receive AG-120 to further evaluate the safety, tolerability, and clinical activity of the MTD. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
42.
  • 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
46.
  • A Phase 1/2 Study to Evaluate MEDI4736
  • This is a multicenter, open-label, first-time-in-human study with a standard 3+3 dose-escalation phase in subjects with advanced solid tumors followed by an expansion phase in patients with advanced solid tumors. An exploration cohort has been added to determine the safety using Q4W dosing.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
47.
  • 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 31-48 of 48 items
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