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Neoplasms clinical trials

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NCT ID: NCT04141449 Recruiting - Breast Cancer Clinical Trials

A Multilevel Intervention to Improve Timely Cancer Detection and Treatment Initiation

Potlako+
Start date: November 18, 2020
Phase: Phase 2
Study type: Interventional

This study evaluates whether the Potlako+ intervention of community education, clinical provider support, and patient navigation can improve access to cancer case for patients presenting with symptoms of cancer. Half of communities will receive the Potlako+ intervention, while the other communities will continue to receive standard programs.

NCT ID: NCT04137900 Recruiting - Clinical trials for Metastatic Solid Tumor

Safety, Tolerability and Pharmacokinetics of a Monoclonal Antibody Specific to B-and T-Lymphocyte Attenuator (BTLA) as Monotherapy and in Combination With an Anti-PD1 Monoclonal Antibody for Injection in Subjects With Advanced Malignancies

Start date: October 30, 2019
Phase: Phase 1
Study type: Interventional

The primary objective is to assess the safety and tolerability of TAB004 as monotherapy and in combination with toripalimab in subjects with selected advanced solid malignancies, including lymphoma, and to evaluate the recommended Phase 2 dose. The secondary objectives are to: 1) describe the pharmacokinetic (PK) profile of TAB004 monotherapy and in combination with toripalimab and to describe the PK profile of toripalimab when administered with TAB004, 2) evaluate antitumor activity of TAB004 monotherapy and in combination with toripalimab; and 3) determine the immunogenicity of TAB004 monotherapy and in combination with toripalimab and to determine the immunogenicity of toripalimab when administered with TAB004. The exploratory objectives are to: 1) evaluate pharmacodynamic effects of TAB004 on its target receptor BTLA, as well as effects on the immune system; 2) evaluate biomarkers that may correlate with activity of TAB004 as monotherapy and in combination with toripalimab; 3) evaluate the utility of BTLA ligand, herpesvirus-entry mediator (HVEM), and additional exploratory biomarkers that could aid in selection of appropriate subjects for TAB004 monotherapy and in combination with toripalimab.

NCT ID: NCT04136834 Recruiting - Clinical trials for Advanced Solid Malignancies

A Phase I Open-label Study for Subjects With Advanced Malignancies

PT01
Start date: April 21, 2021
Phase: Phase 1
Study type: Interventional

This is a first-in-human (FIH) Phase 1 dose escalation study to evaluate the safety, tolerability, PK, PD, and preliminary activity of PT01 administered IV in subjects with advanced malignancies.'

NCT ID: NCT04131413 Recruiting - Clinical trials for Cervical Intraepithelial Neoplasia, Grade III

HPV DNA Vaccine Via Electroporation for HPV16 Positive Cervical Neoplasia

Start date: September 14, 2020
Phase: Phase 1
Study type: Interventional

The primary goal of this phase I open label study is to determine the safety and tolerability of pNGVL4aCRTE6E7L2 DNA vaccine, as administered by intramuscular (IM) injection with TriGrid™ electroporation to both HIV- or HIV+ adult female subjects (≥ 19 years), with biopsy confirmed cervical intraepithelial (CIN) II or III that is human papillomavirus (HPV) 16+.

NCT ID: NCT04130542 Recruiting - Cancer Clinical Trials

Phase 1 Trial of LVGN6051 as Single Agent and in Combination With Keytruda (Pembrolizumab) in Advanced or Metastatic Malignancy

Start date: October 31, 2019
Phase: Phase 1
Study type: Interventional

LVGN6051 is a humanized monoclonal antibody that specifically binds to CD137, and acts as an agonist against CD137. This first in human study of LVGN6051 is designed to establish the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RDE) as well as the recommended Phase 2 dose(s) (RP2D) of LVGN6051, both as a single agent (monotherapy) and in combination with a fixed dose of anti-PD-1 antibody (Pembrolizumab/MK-3475) in the treatment of advanced or metastatic malignancy.

NCT ID: NCT04128085 Recruiting - Clinical trials for Advanced Malignant Tumors

A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3804 in Subjects With Advanced Malignant Tumors

Start date: November 15, 2019
Phase: Phase 1
Study type: Interventional

This is a study to evaluate the tolerance, dose-limiting toxicity (DLT), phase II recommended dose (RP2D), and maximum tolerated dose (MTD) of single and multiple oral doses of TQB3804 in patients with advanced malignant tumors.

NCT ID: NCT04126590 Recruiting - Clinical trials for Advanced Solid Tumors

Phase I Study of KN044 in Locally Advanced/Metastatic Solid Tumors

Start date: January 9, 2020
Phase: Phase 1
Study type: Interventional

This is an open-label, multicenter, dose-escalation phase I study to assess the safety, tolerability and preliminary efficacy of KN044 in participants with all advanced solid tumors who are not able to have current standard anti-tumor therapies. The purpose of this study is to determine the maximum tolerated dose (MTD) , to characterise the safety, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of KN044 as a single agent in adult participants with advanced solid tumors.

NCT ID: NCT04124666 Recruiting - Advanced Cancer Clinical Trials

Clinical Study of Granulocyte Infusion for Advanced Cancer

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

Background & Rationale: For years, most tumor immunotherapy researches have focused on T cell and natural killer (NK) cell therapies, most of which involve amplification and modification of the patient's immune cells for reinfusion therapy. However, for the treatment of solid tumors, there is currently little breakthrough. Recently, researchers have reported a colony of cancer-resistant mice developed from a single mouse that was immune to multiple lethal cancer cell injections. Further research revealed that such anti-cancer immunity can cause rapid shrinkage or disappearance of the tumors in other cancer-bearing mice. Interestingly, this therapeutic effect is due to the donor granulocytes, instead of T cells or NK cells. Infusion of granulocytes is a classic therapy in treating infection associated with granulocytopenia. Currently, clinical collection of blood components, including isolation of granulocytes, is a mature technique. The infusion of granulocytes is a viable anticancer therapy combining the classic technique and novel anticancer approach. This proposed trial will test whether granulocyte infusions from healthy unrelated donors can be used to treat advanced cancer. In the proposed trial, up to 100 Subjects with advanced cancer can be entered. Each patient will be given a dose of (2.0-5.0)x10^10 granulocytes from a different healthy donor every week over a course of 5 doses. The trial will evaluate the subject's cancer 7, 30, 90 and 180 days after the last infusion.

NCT ID: NCT04124198 Recruiting - Quality of Life Clinical Trials

Quality of Life After Primary TORS vs IMRT for Patients With Early-stage Oropharyngeal Squamous Cell Carcinoma

QoLATI
Start date: March 1, 2019
Phase: N/A
Study type: Interventional

Oropharyngeal squamous cell carcinoma (OPSCC) is now the most frequently diagnosed head and neck cancer in Denmark which is mainly due to the increase of Human Papillomavirus (HPV). Patients with HPV-positive OPSCC have a significantly higher survival rate compared to HPV-negative OPSCC. The traditional primary treatment modality in Denmark is Intensity Modulated Radiation Therapy (IMRT), and in advanced stages in combination with chemotherapy. Since 2009, Transoral Robotic Surgery (TORS) has enabled surgeons to perform minimally invasive surgery as an alternative to standard radiotherapy treatment which is considered the primary treatment for OPSCC in many countries. There is a lack of randomised trials comparing long-term functional outcomes after TORS or IMRT. Current data are mostly derived from retrospective studies with selection bias. However, several small retrospective studies have shown promising results when comparing the two treatment modalities in favour of TORS with regards to treatment related swallowing function and quality of life (QoL) without compromising survival outcomes. This study aims to evaluate the early and long-term functional outcomes following two treatment arms 1) TORS combined with neck dissection and 2) IMRT±concurrent chemotherapy with a special focus on swallowing-related QoL.

NCT ID: NCT04123262 Recruiting - Clinical trials for Neuroendocrine Tumors

Tamoxifen for Well Differentiated Neurodendocrine Tumors and Hormone Receptor Positive Expression

Start date: November 13, 2019
Phase: Phase 2
Study type: Interventional

This is a single-arm, single-stage clinical study of tamoxifen for patients with well-differentiated neuroendocrine tumors and radiological progression with positive (> 1%) HR (estrogen and/or progesterone) expression by immunohistochemistry (IHC).