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Solid Tumor clinical trials

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NCT ID: NCT04064359 Recruiting - Solid Tumor Clinical Trials

Safety and Preliminary Efficacy of OBT076 in Recurrent/Metastatic CD205+ Solid Tumors

Start date: July 25, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate OBT076, which is a drug that combines an antibody with an anti-cancer drug. This class of drugs are called Antibody-Drug Conjugates (ADC). Antibodies are normally produced in the human body by the immune system to fight infections but can be designed to target cancer cells and deliver an anti-cancer drug. OBT076 is composed of an antibody that targets the CD205 protein on cancer cells and delivers an anti-cancer drug which can kill them. OBT076 is an "Investigational Drug", which means that it is still being studied and has not yet been approved by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) or any other regulatory authorities to be prescribed by doctors for the treatment of metastatic or recurrent solid tumors. The use of OBT076 in this study is investigational. This is a Phase I research study designed to look at several dose levels of the study drug to find the highest dose level that is safe and well-tolerated (does not cause unacceptable side effects), and to examine the effects of the study drug in a small group of research participants. The study will also look at the effectiveness of OBT076 as an anti-cancer therapy. Once the optimal dose is determined and safety is assessed, additional research participants will be treated at the optimal dose level to further evaluate safety and effectiveness.

NCT ID: NCT04059588 Completed - Cancer Clinical Trials

A Study Investigating the Safety and Tolerability of an Immune Treatment in Cancer Patients With Lesions to the Skin

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

The purpose of this study is to test the safety and tolerability of 2141-V11 in people who have cancer that does not respond to standard treatment and who have skin lesions (skin tumors) associated with their cancer. The study will also test how the body processes and responds to 2141-V11, and if the study drug has cancer fighting activity in people. The study drug activates a naturally occurring protein called CD40. By activating CD40, cells of the immune system are better able to identify and kill cancer cells. We are testing if injection of 2141-V11 into metastasis to the skin will be safe and well tolerated, and may result in immune activation in patients with solid tumors that have metastasis to the skin.

NCT ID: NCT04057729 Completed - Solid Tumor Clinical Trials

IMP4297 Food Effect Trial in Healthy Volunteers

Start date: July 22, 2019
Phase: Phase 1
Study type: Interventional

A phase I, single-site, open-label, randomized, single-dose, two-way crossover study to evaluate the effect of food on the pharmacokinetic characteristics of IMP4297 capsules in China

NCT ID: NCT04050709 Active, not recruiting - Solid Tumor Clinical Trials

QUILT-3.064: PD-L1 t-haNK In Subjects With Locally Advanced Or Metastatic Solid Cancers

Start date: July 18, 2019
Phase: Phase 1
Study type: Interventional

Phase 1 study to assess the safety, preliminary efficacy of PD-L1 t-haNK and to determine the maximal tolerated dose and designate the recommended phase 2 dose in subjects with locally advanced or metastatic solid cancers.

NCT ID: NCT04047589 Completed - Solid Tumor Clinical Trials

Assessing Exercise Behavior and Preferences Among Patients and Oncologists

Start date: April 8, 2019
Phase:
Study type: Observational

The purpose of this study is to understand the preferences and barriers surrounding exercise of both the patients and oncologists within Indiana University Simon Cancer Center. This information will establish gaps in our current care and provide important information to guide future pilot interventions.

NCT ID: NCT04046016 Completed - Solid Tumor Clinical Trials

A Study Using Whole-body PET After Oral Microdose of 18F-labeled Liporaxel in Patients With Solid Tumor

Start date: July 3, 2018
Phase: Early Phase 1
Study type: Interventional

An open-label, single oral dose of therapeutic Liporaxel and microdose 18F-Liporaxel administration study was conducted in two breast cancer patients. Therapeutic dose of Liporaxel was 200 mg/m2 and 18F-Liporaxel was 0.98-2.9 μg (185-555 MBq).

NCT ID: NCT04035473 Completed - Solid Tumor Clinical Trials

A Study to Determine the Bioequivalence of Oraxol in Cancer Patients Treated With Intravenous Paclitaxel

Start date: August 1, 2015
Phase: Phase 1
Study type: Interventional

This is a multicenter, open-label, 2-stage study with a 2-treatment period crossover design. Eligible participants are adults with cancer for whom weekly therapy with IV paclitaxel at a dose of 80 mg/m2 over 1 hour is indicated. Stage 1 will consist of an initial cohort (Cohort 1) up to 6 evaluable participants who will receive a dosing regimen of Oraxol consisting of a 15-mg oral HM30181AK-US tablet plus an oral paclitaxel dose of 205 mg/m2, both administered once daily for 3 consecutive days. The stages and cohorts are further described in the "Study Design - Stages and Cohorts" table below. An interim analysis of pharmacokinetic (PK) data from Cohort 1 will be conducted to determine if the administered regimen would appear likely to achieve bioequivalence(BE) (AUC0-∞), if tested in a greater number of participants in Stage 2. If it appears unlikely that the selected regimen will meet the criteria for BE based on AUC0-∞ data, a second cohort (Cohort 2) of up to 6 evaluable participants may be enrolled in Stage 1, and the dose of paclitaxel in Oraxol may be adjusted by a maximum of +/- 25%. If Cohort 2 is enrolled, a second interim analysis will be conducted. After the interim analysis/analyses (depending on the outcomes), a decision will be made by consensus of the Data Safety and Monitoring Board(DSMB), Kinex, Zenith Technology, and the Principal Investigator as to what dose should be administered in Stage 2. The DSMB will consist of a clinical oncologist, an ethicist, an independent statistician, and additional members, as deemed necessary. A DSMB charter will describe the planned evaluations and decision points used to determine the dose for Stage 2. An additional 18 to 42 evaluable participants will be enrolled into Stage 2 based on the Stage 1 results (AUC0-∞). Thus a total of up to 54 evaluable participants could potentially be enrolled in this study (6 each from Stage 1, Cohorts 1 and 2, and up to 42 participants in Stage 2).

NCT ID: NCT04021277 Recruiting - Colorectal Cancer Clinical Trials

PS101-mediated ACT With Chemotherapy in Liver Metastases From Cancer of Gastrointestinal Origin

ACT
Start date: September 17, 2019
Phase: Phase 1
Study type: Interventional

Part 1: This clinical study will first test the safety and initial effect on the tumour of PS101-mediated ACT when given in combination with standard of care chemotherapy in patients with liver metastases (initially those with any solid tumors and then further in patients just with colorectal cancer [CRC]) in order to identify the recommended dose and schedule of PS101-mediated ACT that can be taken forward for further testing. Part 2: Based on the Part 1 results, another part in patients with liver metastases from CRC and pancreatic cancer (if indicated) may take place following a substantial protocol amendment. This record will focus on Part 1 of the study only and will be updated if Part 2 occurs.

NCT ID: NCT04015609 Recruiting - Solid Tumor Clinical Trials

Psychotherapy Intervention for Latinos With Advanced Cancer

Start date: April 20, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to adapt a counseling intervention called Meaning Centered Psychotherapy to make it culturally relevant for Latinos. Cancer affects patients and their loved ones. Latinos often experience greater challenges due to the cancer. However, few studies and interventions focus on Latinos. We are interested in understanding what affects Latino patients' quality of life, and how to improve it

NCT ID: NCT04013217 Terminated - Solid Tumor Clinical Trials

Evaluate Eribulin ORA in Subjects With Solid Tumors

Start date: July 29, 2019
Phase: Phase 1
Study type: Interventional

This is a nonrandomized, open-label, dosed escalation, safety activity, and PK study to determine the MTD and optimal dosing regimen of Eribulin ORA.