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Solid Tumor/Phase I Clinical Trials

Showing 31-53 of 53 items
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Showing 31-53 of 53 items
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