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Solid Tumor, Adult clinical trials

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NCT ID: NCT05518799 Completed - Prostate Cancer Clinical Trials

CYP3A4 Activity in Patients With Prostate Cancer Versus Male Patients With Other Solid Tumours

Start date: April 22, 2021
Phase: N/A
Study type: Interventional

The hepatic enzyme, cytochrome P450 3A4 (CYP3A4) is important for the metabolism of many drugs including taxanes. Previous reported studies reported a decreases in docetaxel exposure in prostate cancer patients compared to patients with other solid tumours. The difference was 1.8-fold for intravenous administration and 2.8-fold for oral administration. The underlying mechanism for these observations remains to be elucidated. The lower docetaxel exposure with IV and oral docetaxel treatment might be related to a higher CYP3A4 activity in prostate cancer patients. Therefore, it is important to directly compare the CYP3A4 activity with a phenotyping test in prostate cancer patients and patients with other types of solid tumours. This is an in vivo phenotyping studying using midazolam as a probe for CYP3A4 activity in patients with prostate cancer and patients with other solid tumours. The primary objective is the comparison of CYP3A4 activity in prostate cancer patients versus male patients with other types of solid tumours by use of an oral midazolam phenotyping test. Secondary objectives are: (1) measurement of plasma concentrations of midazolam and it's two primary metabolites (1'-hydroxy midazolam and 4'-hydroxy midazolam), (2) determination of the metabolite pharmacokinetics of midazolam. (3) retrospective assessment of single nucleotide polymorphisms of CYP3A4. The exploratory objective is to differentiate between gastro-intestinal and hepatic CYP3A4 activity with oral and intravenous administration of midazolam.

NCT ID: NCT05309187 Completed - Solid Tumor, Adult Clinical Trials

Dose-Escalation and Dose-Expansion Study of IO-202 and IO-202+Pembrolizumab in Solid Tumors

Start date: April 11, 2022
Phase: Phase 1
Study type: Interventional

To assess safety and tolerability of increasing doses of IO-202 either as monotherapy or in combination with pembrolizumab in patients with advanced solid tumors, and select the recommended Phase 2 dose (RP2D).

NCT ID: NCT05078593 Completed - Lymphoma Clinical Trials

A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HLX26 Monoclonal Antibody Injection in Patients With Solid Tumor or Lymphoma

Start date: October 11, 2021
Phase: Phase 1
Study type: Interventional

This study is a first-in-class open-label phase I human clinical study to evaluate the safety and tolerability of HLX26 with escalated doses in the treatment of patients with advanced/metastatic solid tumors or lymphomas.

NCT ID: NCT05074472 Completed - Solid Tumor, Adult Clinical Trials

A Phase 1/2, First-in-Human, Open Label, Dose Escalation Study Of A CSP Targeting Functional Antibody in Solid Tumors

Start date: January 14, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a first-in-human, Phase 1, open label, multicenter, dose escalation study with expansion at the RP2D, to evaluate the safety, tolerability, and preliminary efficacy of ZB131 in patients with solid tumors where prevalence of CSP expression is high. Approximately 12 to 24 patients will be enrolled in the Dose Escalation Stage; the total number of patients will depend on the dose level at which the RP2D is defined. Patients who meet the eligibility criteria during Screening will enter the treatment period. ZB131 will be given via IV every week. Patients will be treated until disease progression or unacceptable toxicities occur.

NCT ID: NCT05054348 Completed - Solid Tumor, Adult Clinical Trials

First-in-human Study of IO-108 as Single Agent and in Combination With a PD-1 Immune Check Point Inhibitor in Patients With Advanced Solid Tumors

Start date: September 30, 2021
Phase: Phase 1
Study type: Interventional

The goal of the clinical trial is to learn about safety, tolerability and preliminary efficacy of IO-108 as monotherapy or in combination with a PD-1 inhibitor in patients with advanced, metastatic solid tumors, and to find a dose of IO-108 that is safe and efficacious to be tested in patients with various solid tumors.

NCT ID: NCT04811781 Completed - Solid Tumor, Adult Clinical Trials

Epidemiological Features and Clinical Course of COVID -19 Infection in Cancer Patients: The Rovid Study

Start date: June 4, 2020
Phase:
Study type: Observational

The study aims to retrospectively collect epidemiological and clinical data in patients with solid tumors and SARS Covid2 infections belonging to oncology centers within the Veneto Oncology Network

NCT ID: NCT04761198 Completed - Clinical trials for Advanced Solid Tumor

A Study of Etigilimab and Nivolumab in Subjects With Locally Advanced or Metastatic Tumors.

Start date: March 23, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, phase 1b/2, multicenter study designed to evaluate the efficacy, safety, tolerability, PK, and pharmacodynamics of etigilimab in combination with nivolumab in subjects with locally advanced or metastatic solid tumors. Subjects will be assigned to receive etigilimab (every 2 weeks) in combination with nivolumab (240 mg every 2 weeks).

NCT ID: NCT04683354 Completed - Solid Tumor, Adult Clinical Trials

Study of HL-085 in Patients With Advanced Solid Tumor Tumors

Start date: December 23, 2020
Phase: Phase 1
Study type: Interventional

The investigational product (IP) HL-085 is an adenosine triphosphate-noncompetitive mitogen activated protein kinase (MEK) inhibitor with a strong selective anti-tumor activity, with a much lower dose than selumetinib. It has been shown strong anti-tumor activities in preclinical studies to treat solid tumors, e.g., melanoma, non-small cell lung cancer, colon cancer and other malignancies with RAF and RAS mutations. Kechow has completed phase I dose escalation study to test HL-085 in patients with advanced NRAS mutated melanoma in China. The tested doses were 0.5 mg, 1mg, 2mg, 3mg, 4mg, 6mg, 9mg, 12mg, 15mg and 18mg BID oral administration and there was no dose-limiting toxicity (DLT) identified. All patients tolerated the study drug reasonably well. This study is a Phase I, open-label, dose escalation study to evaluate tolerability, safety, pharmacokinetic (PK) and preliminary antitumor activities of HL-085 in US patients with advanced solid tumors. The objective of the dose escalation is to evaluate safety and tolerability of selected TID and BID dose regimens in US patient population with advanced solid tumor and establish the Recommended Phase 2 Dose (RP2D). The starting dose for this trial is 12 mg daily oral administration. Three selected daily doses - 12 mg (4mg TID, 6mg BID), 18 mg (6mg TID, 9 mg BID), and 24 mg (8 mg TID, 12 mg BID) will be tested in this study to assess safety and tolerability of HL-085 at the 3 selected dose levels in US patient population with advanced solid tumors.

NCT ID: NCT04515043 Completed - Solid Tumor, Adult Clinical Trials

EXPLORATORY STUDY Addendum to INVAC1-CT-101 (NCT02301754)

Start date: October 16, 2020
Phase: Phase 1
Study type: Interventional

This study will be an exploratory study of long term immunogenicity of INVAC-1 in patients who participated in the INVAC1-CT-101 phase I study (between 2014 and 2018).

NCT ID: NCT04428086 Completed - Solid Tumor, Adult Clinical Trials

A Pharmacokinetic Interaction Study Between Apatinib and Rosuvastatin or Metformin in Solid Tumor Subjects.

Start date: July 27, 2020
Phase: Phase 1
Study type: Interventional

The primary objective of the study was to assess investigate the pharmacokinetic effects of Apatinib on Rosuvastatin or Metformin. The secondary objective of the study was to assess the safety of Apatinib alone or Rosuvastatin/Metformin alone or concomitant medication.