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Solid Tumor, Adult clinical trials

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NCT ID: NCT04200963 Completed - Neoplasms Clinical Trials

A Phase 1a/b Study of IK-175 as a Single Agent and in Combination With Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumors and Urothelial Carcinoma

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

This study will be conducted in adult subjects diagnosed with any form of an advanced or metastatic solid tumors including urothelial carcinoma for which standard therapy is no longer effective or is intolerable. This is a phase 1, multi-center, open label study designed to assess safety and tolerability of IK-175 as a single agent and in combination with nivolumab, to determine the recommended phase 2 dose (RP2D). Disease response, pharmacokinetics (PK), pharmacodynamics, and response biomarkers will also be assessed.

NCT ID: NCT04196257 Recruiting - Solid Tumor Clinical Trials

BP1001-A in Patients With Advanced or Recurrent Solid Tumors

Start date: August 19, 2022
Phase: Phase 1
Study type: Interventional

This is a phase I, open-label, study of BP1001-A in participants with advanced or recurrent solid tumors. The dose escalation phase will determine the safety and the maximum tolerated dose (MTD) or maximum administered dose (MAD) of BP1001-A as a single agent. After the MTD or MAD of BP1001-A is established, the dose expansion phase will commence and determine the safety, toxicity and response of BP1001-A in combination with paclitaxel.

NCT ID: NCT04175899 Active, not recruiting - Solid Tumor, Adult Clinical Trials

Effectiveness of Pharmacist Intervention on Capecitabine Relative Dose Intensity, Adherence, Knowledge & Safety Among Cancer Patients in Malaysia

POCCP1
Start date: December 10, 2019
Phase: N/A
Study type: Interventional

Over the past decade, oral administration of chemotherapy has significantly increased and is anticipated to continue to grow. Despite the conveniences, these oral regimens can be complex and pose challenge to patient adherence. Further safety concerns are warranted due to insufficient patient education, general perception of reduced toxicity with oral treatment, improper prescribing practice, and the lack of monitoring of observable adverse effects. Therefore, effective medication counselling and patient education is vital to empower patients and their caregivers to increase adherence and safely managed medication to achieve optimal treatment outcome. This study aims to evaluate the effectiveness of pharmacist intervention with structured oral chemotherapy education and patient monitoring on capecitabine treatment effectiveness (Relative Dose Intensity (RDI), Adherence and Persistence), safety outcomes (Adverse Event, Drug Related Problem and Health service utilization) and chemotherapy knowledge and self-efficiency among cancer patient care in Penang, a northern state oncology referral centre. There are numerous published studies of pharmaceutical care implementations focusing mainly on in-patient setting and currently evolving in ambulatory cancer patients especially in western countries compared to Asian region. However systematic reviews show major gap still exist with paucity of scientific evidence on the effectiveness of therapeutic educational interventions for improving patient safety and adherence to oral chemotherapy mainly due to study design and method that are unable to strongly prove the outcome. Hence highlighting the novelty and significance for this research using randomized controlled design, standardized & validated tools for multimodal pharmacist intervention, long-term clinical outcome such as RDI with longitudinal assessment till treatment completion.

NCT ID: NCT04169178 Recruiting - Solid Tumor, Adult Clinical Trials

Evaluate Safety, Tolerability and PK of HLX55 in Patients With Advanced Solid Tumors With Different cMET Status

Start date: March 3, 2020
Phase: Phase 1
Study type: Interventional

A mutilpe-center, open-label, dose-escalation Phase I clinical trial to evaluate the safety and the tolerability of HLX55 in patients with advanced solid tumors overexpressing/Mutation/Amplification cMET after failure of standard of care.

NCT ID: NCT04165772 Recruiting - Solid Tumor Clinical Trials

Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors

Start date: December 11, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find out whether the study drug, TSR-042, followed by standard chemoradiotherapy (the chemotherapy drug capecitabine + radiation therapy) and standard surgery is an effective treatment for advanced dMMR solid tumors. The study will also look at the safety of the study drug.

NCT ID: NCT04165330 Active, not recruiting - Clinical trials for Non Small Cell Lung Cancer

Evaluation of AL3818 in Combination With Nivolumab in Solid Tumors

Start date: October 17, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This study evaluates the safety and efficacy of AL3818 (anlotinib) hydrochloride in combination with Opdivo (nivilumab) for the treatment patients with of metastatic, advanced, or recurrent solid tumors. All participants will receive open-label AL3818 with nivolumab. Part 1 consists of a dose finding phase to determine the recommended phase 2 dosage of AL3818 with nivolumab. Part 2 consists of a dose expansion phase, evaluating the safety and efficacy of the combination in patients cohorts including metastatic, advanced, or recurrent soft tissue sarcomas, non-small cell lung cancer, and small cell lung cancer.

NCT ID: NCT04143711 Recruiting - Solid Tumor, Adult Clinical Trials

Study of DF1001 in Patients With Advanced Solid Tumors

Start date: November 11, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

DF1001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cell activation signals to specific receptors on cancer cells. The study will occur in two phases. The first phase will be a dose escalation phase, enrolling patients with various types of solid tumors that express human epidermal growth factor receptor 2 (HER2). The second phase will include a dose expansion using the best dose selected from the first phase of the study. Multiple cohorts will be opened with eligible patients having either HER2 activated non-small cell lung cancer, hormone receptor (HR) positive HER2 negative metastatic breast cancer, or HER2 positive metastatic breast cancer. DF1001-001 will be administered as monotherapy or in combination; combinations are DF1001 + nivolumab, DF1001 + Nab paclitaxel, and DF1001 + sacituzumab govitecan-hziy.

NCT ID: NCT04130516 Recruiting - Solid Tumor, Adult Clinical Trials

Study Assessing MTD, Safety, Tolerability, PK and Anti-tumor Effects of LNS8801alone and With Pembrolizumab

Start date: October 21, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This Phase 1/2, first-in-human, open-label, multicenter study follows a 3+3 ascending dose escalation design to determine the MTD/RP2D and to characterize the safety, tolerability, PK, and antitumor effects of LNS8801 alone and in combination with pembrolizumab. The study will include a dose escalation phase, a dose expansion phase, and phase 2A cohorts. Up to 200 patients will be accrued for this study. Up to 15 study sites in the United States will participate in the study.

NCT ID: NCT04121442 Recruiting - Solid Tumor, Adult Clinical Trials

Isunakinra Alone and in Combination With a PD-1/PD-L1 Inhibitor in Patients With Solid Tumors

Start date: September 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Isunakinra - a potent Interleukin-1 receptor inhibitor - will be given to patients with solid tumors to determine safety and tolerability of three different doses. Isunakinra will then be combined with a PD-(L)1 inhibitor. Pharmacokinetics and Pharmacodynamic effects of monotherapy treatment as well as the combination will be evaluated.

NCT ID: NCT04105335 Active, not recruiting - Solid Tumor, Adult Clinical Trials

A Study of MTL-CEBPA in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumours (TIMEPOINT)

TIMEPOINT
Start date: November 13, 2019
Phase: Phase 1
Study type: Interventional

This is an open label Phase 1a/1b study in patients who have advanced solid cancer tumours. Patients will receive MTL-CEBPA (an experimental drug) in combination with pembrolizumab (a drug which has been given approval for use for some tumour types). The Phase 1a dose escalation part of the study is designed to establish which doses of MTL-CEBPA are safe and well-tolerated when combined with the standard dose of pembrolizumab. Patients recruited to this part of the study will be those whose cancer progressed on standard treatment(s) or for whom no treatments are available. Phase 1b the dose expansion part of the study will further explore how safe and well-tolerated these two drugs are when combined and will assess if the combination of drugs could potentially reduce the size of tumours. Participants in this part of the study will receive the experimental drug (MTL-CEBPA) at a dose which is considered safe and well-tolerated based on data from the first part of the study (Phase 1a). Participants will remain in the study taking study drugs until either death, or they choose to withdraw from the study.