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NCT ID: NCT06059508 Recruiting - Clinical trials for Advanced Malignant Tumor

Phase I Clinical Study of SHR-5495 in the Treatment of Patients With Advanced Malignant Tumors

Start date: October 25, 2023
Phase: Phase 1
Study type: Interventional

This study is an open, multicenter, dose-increasing/dose-expanding/efficacy expanding Phase I clinical study aimed at evaluating the tolerance, safety, PK, PD, and immunogenicity of SHR-5495 in the treatment of advanced malignant tumor patients, and preliminarily observing its anti-tumor efficacy. The entire study was divided into three stages: dose escalation, dose extension, and efficacy extension.

NCT ID: NCT06059391 Recruiting - Clinical trials for Acute Myeloid Leukemia

CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant

Start date: August 30, 2024
Phase: Phase 2
Study type: Interventional

This phase II clinical trial tests how well the cytomegalovirus-modified vaccinica Ankara (CMV-MVA) Triplex vaccine given to human leukocyte antigens (HLA) matched related stem cell donors works to prevent cytomegalovirus (CMV) infection in patients undergoing hematopoietic stem cell transplant. The CMV-MVA Triplex vaccine works by causing an immune response in the donors body to the CMV virus, creating immunity to it. The donor then passes that immunity on to the patient upon receiving the stem cell transplant. Giving the CMV-MVA triplex vaccine to donors may help prevent CMV infection of patients undergoing stem cell transplantation.

NCT ID: NCT06058312 Recruiting - Neoplasms Clinical Trials

Individual Food Preferences for the Mediterranean Diet in Cancer Patients

MyPrefMed
Start date: September 4, 2023
Phase: N/A
Study type: Interventional

This is an exploratory study aimed at characterizing adherence to the Mediterranean diet among patients undergoing treatment for cancer, in relation to sensory alterations that occur during treatment. The primary strength of this project lies in the consideration of a large number of variables that scientific literature has shown to play a significant role in the dietary behavior of patients. The project's multidisciplinary approach, which takes into account both sensory perception and psychological dimensions, can enrich scientific knowledge on the subject, enabling a better understanding of the dietary behaviors of cancer patients undergoing treatment. One of the main strengths of the project is that taste and smell reactivity will be tested using a combined approach that includes the evaluation of responses to PROP (Propylthiouracil - a bitter compound), selected aromas and odors, responses to model foods belonging to the Mediterranean diet in which the intensities of selected sensory properties are expected to be affected by chemotherapy (e.g., sweetness and freshness). To date, no study has investigated adherence to the Mediterranean diet in such a wide range of patients. The choice of a Mediterranean diet framework is based on evidence defining this type of diet as a health promoter, improving health and preventing diseases and health complications. The Mediterranean diet includes the food variety present in the specific region chosen for the study, ensuring variety and availability of local products. The selection of the Antoine Lacassagne Center in Nice is based on the need to study the dietary preferences of a Mediterranean population familiar with Mediterranean diet products. This project could serve as the foundation for a dietary development aspect, in which foods adapted to cancer patients will be created and tested to mitigate issues of malnutrition. Expected Benefits Addressing the scientific question regarding the impact of sensory and psychological variables on adherence to the Mediterranean Diet and dietary behavior of cancer patients undergoing treatment will help identify individual variables to consider in assisting patients in adopting health-promoting behavior and reducing malnutrition. Expected Risks The research project does not involve maneuvers or the implementation of care procedures other than those to which patients would be subjected if they were not participating in the study. This research involves no specific risks, except for possible risks of allergies or food intolerances related to the sensory testing session. The dietary models used only include food ingredients normally available in markets. In order to test the taste sensitivity index, the response to propylthiouracil (PROP) will be evaluated using paper discs previously soaked in a solution composed of water and PROP according to the method of Zhao et al. (2003). This procedure has been safely used in children as well as in several studies (including patients undergoing chemotherapy) approved by ethics committees in multiple institutes from various countries. Scientific Impact The project will provide information about the variables that impact the dietary behavior of patients undergoing chemotherapy. This knowledge will be useful in developing principles that contribute to reducing malnutrition rates in oncology patients. Methodology This is an exploratory study aimed at characterizing adherence to the Mediterranean diet among patients with cancer undergoing treatment, who may experience changes in their relationship with food as well as their dietary behavior. Adherence to the Mediterranean diet will be studied in cancer patients at T0 (before the start of treatment) and at T1 (after 9 weeks of treatment). A comparison will be made between patients without sensory alterations and patients with taste and/or smell alterations at T1. The psychological and sensory variables impacting dietary behavior will also be measured and correlated with adherence to the Mediterranean diet and the presence or absence of sensory alterations.

NCT ID: NCT06057922 Recruiting - Clinical trials for Advanced Solid Tumor

A Study YL201 in Patients With Selected Advanced Solid Tumors

Start date: September 22, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is A Multicenter, Open-Label, Phase 1/2 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients with Selected Advanced Solid Tumors. The study will include 2 parts: Phase 1 dose expansion stage (Part 1) followed by a Phase 2 stage with expanded sample size (Part 2). Part 1 will estimate the RP2D in dose expansion cohorts of patients with not linited to non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), nasopharyngeal carcinoma (NPC), esophageal squamous cell carcinoma (ESCC), metastatic castration-resistant prostate cancer (mCRPC), etc.. Part 2 will include patients with selected advanced solid tumor types enrolled at the RP2D to further assess the efficacy and safety of YL201.

NCT ID: NCT06057636 Withdrawn - Breast Cancer Clinical Trials

Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study

Start date: September 8, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to compare two hypnotic interventions for Black women with advanced cancer pain in preparation for a well-powered phase III study. The investigators plan to enroll 30 adult Black women with advanced cancer pain in a 2-arm pilot randomized controlled trial (RCT). The primary aim will be to evaluate the feasibility of conducting the 2-arm clinical trial. It is hypothesized that at least 75% of participants in both study arms will complete study requirements. The secondary aims will be to evaluate the participant's experience with the intervention and to determine the effect size of the intervention on pain severity.

NCT ID: NCT06057038 Recruiting - Clinical trials for Malignant Solid Tumor

A Safety Trial of GEN1042 in Japanese Subjects With Malignant Solid Tumors

Start date: November 24, 2023
Phase: Phase 1
Study type: Interventional

This study evaluating GEN1042 will include multiple parts. In this study, GEN1042 alone (phase 1a) or GEN1042 in combination with other anticancer drug(s) (phase 1b) will be evaluated in Japanese participants. The main purpose is to assess the safety and tolerability of GEN1042 monotherapy or GEN1042 in combination in Japanese study participants with cancer.

NCT ID: NCT06056323 Recruiting - Solid Tumor, Adult Clinical Trials

A Study of HB0045 Injection in Patients With Advanced Solid Tumors

Start date: July 18, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase I/II, open-label, multicenter study . During the study, subjects will be evaluated for safety, toxicity, tolerability, PK/PD, immunogenicity, biomarkers, and antitumor activity of HB0045. The phase I study will enroll up to 54 subjects with advanced solid tumors who have progressed on or after standard of care therapy and for whom there is no further treatment available that in the judgement of the patient's physician would be beneficial. One cycle is defined as 21 days.

NCT ID: NCT06054932 Recruiting - Clinical trials for Advanced Solid Tumor

Safety, Tolerability, and Immunogenicity of LK101 Alone in Participants With Incurable Solid Tumors

Start date: September 5, 2023
Phase: Phase 1
Study type: Interventional

This is an open-labeled, single-center phase I study in patients with incurable advanced solid tumors, who failed with all previous standard therapy. The aim is to observe and evaluate the safety, tolerability, and immunogenicity of LK101 injection.

NCT ID: NCT06051760 Not yet recruiting - Malignant Neoplasm Clinical Trials

NV-001 in the Treatment of Advanced Solid Tumors

Start date: December 1, 2023
Phase: Phase 1
Study type: Interventional

This study is a single-center, open, dose-escalation Phase I clinical study. It is designed to evaluate the safety, tolerability, preliminary efficacy and immunogenicity of treating NV-001, a king of hybrid-membrane-based tumor vaccine in patients with advanced solid tumors.

NCT ID: NCT06051695 Recruiting - Cancer Clinical Trials

A Study to Evaluate the Safety and Efficacy of A2B694, a Logic-gated CAR T, in Subjects With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression

EVEREST-2
Start date: April 3, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this study is to test A2B694, an autologous logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), ovarian cancer (OVCA), mesothelioma (MESO), and other solid tumors that express MSLN and have lost HLA-A*02 expression. The main questions this study aims to answer are: Phase 1: What is the recommended dose of A2B694 that is safe for patients Phase 2: Does the recommended dose of A2B694 kill the solid tumor cells and protect the patient's healthy cells Participants will be required to perform study procedures and assessments, and will also receive the following study treatments: Enrollment and Apheresis in BASECAMP-1 (NCT04981119) Preconditioning Lymphodepletion (PCLD) Regimen A2B694 Tmod CAR T cells at the assigned dose