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NCT ID: NCT06171178 Recruiting - Solid Tumor Clinical Trials

A Study of ASP1012 in Adults With Solid Tumors

Start date: February 28, 2024
Phase: Phase 1
Study type: Interventional

ASP1012 is a type of virus called an oncolytic virus which is used to treat some cancers. ASP1012 was changed in a laboratory to infect and kill cancer cells, leaving healthy cells alone. It also makes the cancer cells visible to the immune system which will fight the cancer cells. Before ASP1012 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. This will help find a suitable dose for future studies and check for potential medical problems from the treatment. In this study, ASP1012 is being tested in humans for the first time. ASP1012 has already been tested in the laboratory and in animals. This is the standard way new potential treatments are developed. People in this study will be adults whose tumor has either grown outside of the area where it started (locally advanced) or it has spread to other parts of the body (metastatic). They will receive ASP1012. Also, some people will receive ASP1012 with pembrolizumab, an approved medicine. There are 2 main aims of this study. The first is to learn if people with certain solid tumors can tolerate different doses of ASP1012. The second is to find a suitable dose of ASP1012. This study will be in 3 parts. Part 1 is called Dose Escalation. People with locally advanced or metastatic tumors can take part. They will have been previously treated with all available standard cancer therapies. Different small groups of people will receive lower to higher doses of ASP1012. For each dose, any medical problems will be recorded. This will help to find suitable doses of ASP1012 to use in Parts 2 and 3 of the study. The first group will receive the lowest dose of ASP1012. A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP1012. The panel will do this for each group until all groups have taken ASP1012 or until suitable doses have been selected for Parts 2 and 3. Part 2 is called Dose Expansion. 3 groups will take part: people with previously-treated melanoma (a type of skin cancer) that have not responded to their treatment (refractory) or their cancer has come back (relapsed), people with newly-diagnosed or untreated melanoma, and people with previously-treated solid tumors. People with previously-treated melanoma will receive ASP1012 at the dose worked out from Part 1. People with previously-treated solid tumors will receive ASP1012 with pembrolizumab. The first few people will receive ASP1012 at a lower dose than the dose worked out from Part 1, to check the safety of the treatments being given together. If there are no safety issues: the next people in the solid tumor group will receive ASP1012 at the dose worked out from Part 1, with pembrolizumab; also people with untreated melanoma will receive ASP1012 at the dose worked out from Part 1, with pembrolizumab. Part 3 is also a Dose Expansion for people with other specific cancers. These are stomach cancer, ovarian cancer, or colorectal cancer. If people with certain tumors respond well in Parts 1 and 2 of the study, other people with this same type of tumor can also take part in Part 3. For all parts of the study, ASP1012 will be given through a vein. This is called an infusion. Each treatment cycle is 21 days long. People will start with 3 treatment cycles. People in the study may receive extra treatment cycles, if they respond well to treatment. People with melanoma who are receiving ASP1012 with pembrolizumab will not be offered the extra treatment cycles. People can stop leave the study early if: they have medical problems from the treatment; their cancer gets worse; they start other cancer treatment; they ask to stop treatment; or they do not come back for treatment. People will visit the clinic on certain days during their treatment. Some visits will be virtual or by phone. During all clinic visits, the study doctors will check for any medical problems from ASP1012. They will also check vital signs. Vital signs include temperature, pulse, breathing rate, the amount of oxygen in the blood, and blood pressure. At some visits, other checks will also include a medical examination, and an electrocardiogram (ECG) to check the heart rhythm, blood draws and urine samples for testing. A tumor sample, if available, will be taken during the first treatment cycle. People will have imaging scans and have blood draws for testing every 6 weeks during and after treatment. This will stop if they leave the study early. People will visit the clinic within 7 days and 30 days after stopping treatment. At both visits, the study doctors will check for any medical problems from ASP1012. Other checks will include a medical examination, blood draws and urine samples for testing and checking vital signs. An ECG will also be done at the 7-day visit. After the 30-day visit, clinic staff will phone people in the study every 12 weeks to check the condition of their cancer for up to 1 year.

NCT ID: NCT06170385 Recruiting - Neoplasms Clinical Trials

Pediatric Early Rehabilitation in Acute Lymphoblastic Leukemia

PEACE
Start date: April 15, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the feasibility and acceptability of a hybrid in-person and virtual individualized physiotherapy program using the Healthy Eating and Active Living (HEAL-ME) online platform for children diagnosed with acute lymphoblastic leukemia. We would like to know if this type of hybrid program delivery model is feasible, and if children and their parents are willing and able to participate in the program. We will do this by recording how many, and what type of physiotherapy sessions (in-person or virtual) are completed, what resources offered on the platform are accessed, and how many children complete the assessments.

NCT ID: NCT06170294 Recruiting - Clinical trials for Advanced Solid Tumor

MAGE-A4-directed TCR-T in the Treatment Amongst Subjects With Advanced Solid Tumors

Start date: January 1, 2024
Phase: Phase 1
Study type: Interventional

A single-arm, open-label, dose exploratory study to evaluate the safety, efficacy, and pharmacokinetics of autologous humanized anti-MAGE-A4 T cell receptor-engineered T cell (TCR-T) in advanced solid tumors.

NCT ID: NCT06170190 Recruiting - Clinical trials for Locally Advanced Unresectable or Metastatic Solid Tumors

A Multicentre,Study of IBI133 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumours

Start date: January 16, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multicentre, open-label, first-in-human, phase 1/2 study of IBI133 in subjects with unresectable, locally advanced or metastatic solid tumours. Phase 1 section includes three parts, IBI133 dose escalation part, and IBI133 monotherapy dose expansion part. The objective of phase 1 section is to identify MTD/recommended dose for expansion (RDE) of IBI133 monotherapy . The objective of phase 2 section is to further explore efficacy, safety and tolerability of IBI133 monotherapy at RDE in specified tumour population. The treatment cycle of the study is defined as every 3 weeks (21 days).

NCT ID: NCT06169644 Not yet recruiting - Clinical trials for Gestational Trophoblastic Neoplasia

The Psychological Impact of GTN on Women Who Have Completed Chemotherapy Treatment

PI-GTN
Start date: April 22, 2024
Phase:
Study type: Observational

A cross-sectional retrospective study of a sample of 20 women who completed single agent or multi agent chemotherapy: between 6 weeks and 24 months post treatment involving a semi structured telephone interview. A patient sample of 20 is proposed for the study. These are all the patients who meet the inclusion criteria below and are thus eligible for the study. These patients will be contacted via telephone by the principal investigator to inform them of the study and invite participation. A proposed sample size of 20 is sufficient to generate data to address the central questions and furthermore, this sample size is adequate because the intention is to gain insight into the experiences of patients' perceptions about their psychological experiences. Objectives: - Gaining insight into the emotional impact of GTN post treatment - Ascertaining if health professionals are providing adequate psychological support - Identifying sources of support that patients accessed post completion of treatment - Identifying potential areas of improvement in the follow up support for future patients Criteria for inclusion: - Treated with chemotherapy for a GTN diagnosis - Completed treatment between 6 weeks and 24 months - Are able to provide informed consent - Have no cognitive impairment as judged by the treating clinician Criteria for exclusion - Treatment received less than 6 weeks ago - Treatment received more than 24 months ago - Non-English speaking Outcome measures are not appropriate in this qualitative study. However outputs from this study include increasing knowledge and insight into: - patients' experiences of their psychological experiences post chemotherapy - patients' perspective of the support received after their treatment - potential areas of improvements in care

NCT ID: NCT06169163 Recruiting - Oesophageal Cancer Clinical Trials

Volatile Organic Compounds as Breath Biomarkers in Squamous Oesophageal Neoplasms

ViSON
Start date: December 1, 2023
Phase:
Study type: Observational

Oesophageal Squamous Cell Carcinoma (OSCC) is a cancer of the food pipe that affects around 2000 patients in the UK every year. It is often detected at an advanced stage, resulting in poor survival (5-year survival less than 20%). Early detection can improve survival (5-year survival >70%). Therefore, early detection is vital to improving survival. There are no national screening guidelines, and an endoscopy (A camera test to look at the food pipe) is the only available test to detect OSCC. Early detection of OSCC is challenging for many reasons. Firstly, early disease symptoms are non-specific, which patients often overlook. Secondly, 'Alarm' symptoms such as weight loss, difficulty swallowing or vomiting blood are signs of advanced stage. Lastly, endoscopy is an invasive test with associated risks and significant discomfort. The investigators propose to develop a breath test for patients with non-specific symptoms. Breath testing has the ideal characteristics for a triage test because it is non-invasive, simple to perform, cost-effective and highly acceptable to patients. The test is based on identifying volatile organic compounds (VOCs, small molecules) that are produced by the cancer and released in breath. The breath test will be offered by General Practitioners (GPs) to patients with non-specific symptoms. Those who test positive will be referred for an urgent camera test, and those who test negative can be reassured.

NCT ID: NCT06167486 Recruiting - Clinical trials for Advanced Malignant Tumors

SG2918 For Advanced Malignant Tumors

Start date: December 26, 2023
Phase: Phase 1
Study type: Interventional

This is a Phase I, open-label, dose escalation and dose expansion study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SG2918 in subjects with Advanced Malignant Tumors who are refractory or resistant to standard therapy, or without available standard or curative therapy.

NCT ID: NCT06167421 Not yet recruiting - Clinical trials for Pancreatic Neuroendocrine Tumor

Comparison of Kimura Versus Warshaw Technique for Laparoscopic Spleen-Preserving Distal Pancreatectomy

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

This study aims to compare the surgical outcomes of laparoscopic spleen-preserving distal pancreatectomy using the Kimura technique versus the Warshaw technique. The primary focus is on the rates of unplanned splenectomy, occurrence of severe complications, as well as intraoperative and perioperative outcomes of both techniques.

NCT ID: NCT06167356 Recruiting - Bladder Cancer Clinical Trials

Study on the Occurrence of Possible Relapses and on the Quality of Life in Patients Who Underwent TURBK.

Start date: November 27, 2013
Phase:
Study type: Observational

A database has been created and will be used in which data will be collected in electronic format relating to adult patients who underwent one of the following endoscopic resection surgeries: TURBK, MAPPING, TURBK SECOND LOOK, BLADDER BIOPSIES.

NCT ID: NCT06167317 Recruiting - Clinical trials for Advanced Solid Tumors

Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors

Start date: January 9, 2024
Phase: Phase 1
Study type: Interventional

The main goal of this first in human (FIH) study is to learn about the safety and dosing of GS-0201 when given alone or in combination with sacituzumab govitecan (SG) in participants with advanced solid tumors. The primary objectives of this study are to: - To assess the safety and tolerability of GS-0201 as monotherapy and in combination with SG in participants with selected advanced solid tumors - To identify the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of GS-0201 as monotherapy and the MTD and/or the RP2D and dosing schedule of GS-0201 in combination with SG in participants with selected advanced solid tumors