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Solid Tumors clinical trials

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NCT ID: NCT04937686 Not yet recruiting - Pancreatic Cancer Clinical Trials

A Phase I Trial of ProAgio, an Anti- Alpha-v-beta3 Integrin Cytotoxin, for Previously Treated Advanced Pancreatic Cancer and Other Solid Tumor Malignancies

Start date: July 2, 2021
Phase: Phase 1
Study type: Interventional

Background: - Pancreatic cancer is the third leading cause of death from cancer in the United States. - The median overall survival for patients with metastatic disease and excellent performance status receiving the most effective combination chemotherapy regimens remains less than 1 year - Pancreatic ductal adenocarcinoma (PDAC), the most common pancreatic cancer histology, is surrounded by a dense desmoplastic stromal reaction generated by cross-talk between tumor cells and the cancer associated stellate cells (CASC) and fibroblasts (CAF) in the microenvironment. - This stroma physically inhibits delivery of therapeutic drugs to tumor cells, secretes growth factors and nutrients that promote therapy resistance and cancer cell survival and is also highly immunosuppressive - Activated CASCs, CAFs and angiogenic endothelial cells which form the abnormal vasculature around tumors, all express high levels of integrin vbeta3. - ProAgio is a rationally designed pegylated peptide drug that binds to integrin vbeta3 at a novel binding site that directly triggers cell apoptosis - ProAgio induces apoptosis of CASCs and angiogenic endothelial cells in pre-clinical models, inhibiting tumor growth and prolonging animal survival - Safety of ProAgio in rodent and non-human primate models has been established - ProAgio has never been tested in humans Primary Objectives: To determine the recommended phase 2 dose (RP2D) of ProAgio in participants with previously treated advanced solid tumors for which no curative therapy exists Eligibility: - Adults >= 18 years of age - Histologically confirmed solid tumor malignancy for which no curative therapy exists as confirmed by the NCI Laboratory of Pathology - For the expansion cohort only: Histologically confirmed diagnosis of pancreatic cancer that is not neuroendocrine - Participants must have received at least one prior systemic treatment - Adequate end organ function is required - Participants in the Biopsy Arm of the expansion cohort must have disease amenable to safe biopsy and willingness to undergo the procedure Design: - This is a Phase I study to assess the safety of ProAgio in Participants with advanced solid tumor malignancies including pancreatic cancer - All participants will receive ProAgio until disease progression, unacceptable toxicity, or withdrawal from study - For the dose escalation cohort, a modified 3+3 design with accelerated dose escalation in initial cohorts will be used - For the expansion cohort, all participants will receive ProAgio at the ideal dose identified during the dose escalation - The expansion cohort has two arms: standard arm and biopsy arm. Pre- and post-treatment tumor biopsy is optional for participants enrolled in the standard arm, but mandatory for participants enrolled in the biopsy arm....

NCT ID: NCT04727164 Not yet recruiting - Solid Tumors Clinical Trials

Study Investigating Safety,Tolerability,Pharmacokinetics and Antitumor Activities of HBM4003 Combine With Toripalimab

Start date: February 28, 2021
Phase: Phase 1
Study type: Interventional

HBM4003 in combination with Toripalimab. The expected duration of treatment for each subject will vary according to the number of cycles completed; the number of cycles will depend on whether the subject benefits from the treatment. The study consists of a 4-week screening period, a 21-day treatment cycle (repeatable, depending on the presence/absence of clinical benefit), EOT visit after discontinuation of treatment, and 2 follow-up visits 28 days (± 2 days) and 84 days (± 5 days) after the last study medication.

NCT ID: NCT03503604 Not yet recruiting - Solid Tumors Clinical Trials

A Study of Anti-VEGF Monoclonal Antibody hPV19 in Patients With Solid Tumors

Start date: May 1, 2018
Phase: Phase 1
Study type: Interventional

hPV19 is a monoclonal antibody (mAb) directed against vascular endothelial growth factor (VEGF). hPV19 binds to human VEGF with unique binding site on VEGF different from that of Bevacizumab(Avastin) and inhibits the binding of VEGF to it's receptors, VEGF-R1 and VEGF-R2. By preventing VEGF binding to its receptors, growth of tumor blood vessels are inhibited and tumor growth prevented or slowed. In this study we are investigating the tolerability, safety, pharmacokinetics and anti-tumor activity of hPV19 in combination with chemotherapy in patients with solid tumors. hPV19 will give to patients by intravenous(i.v.) infusion with a single and multiple doses.

NCT ID: NCT02858232 Not yet recruiting - Solid Tumors Clinical Trials

MASCT-I Treatment for Advanced Solid Tumor

Start date: August 2016
Phase: Phase 1/Phase 2
Study type: Interventional

Multiple Target Antigen Stimulating Cell Therapy (MASCT-I) is a new immunotherapy that dendritic cells(DC) was induced from autologous peripheral blood. The DC can then be loaded with antigens and re-infused. In vitro, antigen-pulsed DC can stimulate autologous T-cell proliferation and induction of autologous specific cytotoxic T-cells(CTL),similarly re-infused. The previous research data showed that MASCT had the modest overall response and less adverse effects for Hepatocellular Carcinoma patients. The study is aimed to evaluate the safety of MASCT-1 in patients with advanced solid tumors.