View clinical trials related to Neoplasms.
Filter by:This clinical development plan for T-1201 will begin with a first-in-human (FIH), open label, multi-center Phase I dose-escalation to evaluate the safety, tolerability, and human pharmacokinetics of T-1201 and determine the maximum tolerated dose (MTD) levels in patients with advanced solid cancer. The further Phase II study will then be designed based on the safety, pharmacokinetics, and preliminary efficacy results from the FIH Phase I study. The initial part of the Phase I study is a safety, tolerability, and pharmacokinetic phase wherein T-1201 Injection will be intravenous administered to patients with advanced solid cancers. The study will be an open label, multi-center Phase I dose-escalation study. Approximately 30-40 patients will be enrolled for the dose-escalation phase. Actual number of patients will be determined by the number of dose cohorts until maximum tolerated dose (MTD) is reached. The modified accelerated titration design will be used for dose escalation. The initial dose regimen will be 18 mg/m 2 of T-1201 Injection once every 4 weeks in 28-day cycles. Doses will escalate in the following sequence: 18, 36, 71, 119, 178 and 249 mg/m 2 of T-1201 Injection. Dose escalation will cease when 2/3 or 2/6 patients experience a DLT, or a dose of 249 mg/m 2 is reached. A DLT must occur within the first cycle (Cycle 1) to determine dose escalation between cohorts. If 2/3 or 2/6 patients experience DLTs at the initial dose level of 18 mg/m 2 , 2 more dose levels lower than 18 mg/m 2 will be added to the study. No human study has been conducted for product T-1201, the benefits/risks of T-1201 is therefore not available at this stage. Since T-1201 is a prodrug of SN-38 with target delivery design, the benefits/risks ratio of T-1201 would thus be expected to be more favorable than irinotecan product (CAMPTOSAR ® , Pfizer).
This research study is evaluating a new type of personalized neoantigen cancer vaccine（iNeo-Vac-P01）combined with anti-PD-1 antibody and radiofrequency ablation as a possible treatment for patients with advanced solid tumors. The primary objective of this trial is to evaluate safety, tolerability and immunogenicity of iNeo-Vac-P01 in combination with anti-PD-1 and radiofrequency ablation, so as to provide a new personalized therapeutic strategy for patients. It is known that cancer patients have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the participant's body fight any tumor cells that could cause the cancer to come back in the future. The study will examine the safety of the vaccine when given at several different time points and will examine the participant's blood cells for signs that the vaccine induced an immune response.
This is a first-in-human Phase 1a/1b multicenter, open-label oncology study designed to evaluate the safety and anti-cancer activity of HSK29116 in patients with advanced B-cell malignancies.
This is a Phase 1/1b open-label, dose-escalation, and cohort expansion study with BID (tablet) oral dose of MPT-0118 in subjects with advanced or metastatic refractory solid tumors. The study will be conducted in 3 parts: - Part A: MPT-0118 dose-escalation - Part B: MPT-0118 dose-escalation in combination with pembrolizumab - Part C: Cohort expansion of MPT-0118 in combination with pembrolizumab
The main purpose of this study is to determine the effectiveness of the study drug pacritinib in people with relapsed or refractory lymphoproliferative disorders.
This phase II trial studies the effects of hyperthermic intraperitoneal chemotherapy (HIPEC) in treating patients with pancreatic cancer that has spread to the internal abdominal area (peritoneal metastasis). Chemotherapy drugs, such as nab-paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. HIPEC involves "heated" chemotherapy that is placed directly in the abdomen through laparoscopic instruments, instead of through an intravenous injection. This study may help doctors determine how safe and effective HIPEC work in treating patient with pancreatic cancer.
The main purpose of this study was to assess the safety, tolerability, and efficacy when combining SHR-1701 and BP102 in participants with certain cancers. This study was conducted in 2 phases, Phase Ib and Phase II.
Q-1802 is a bispecific antibody targeting both the tumor-specific antigen Claudin 18.2 and the immune checkpoint PD-L1. This is a multi-center, single-arm, open-label design to evaluate the safety and tolerance of Q-1802 in patients with advanced solid tumors, together with an assessment of pharmacokinetic characteristics and efficacy. The study consisted of two compartments: the dose-exploration stage and the dose-extension stage.
The primary purpose of this study is to assess the safety and tolerability of RP-6306 alone and in combination with RP-3500 or in combination with Debio 0123 in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) and assess preliminary anti-tumor activity.
The Phase I trial is planned to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of MBS8(1V270) in subjects with advanced solid tumours. The trial is designed to provide data for further clinical development of MBS8(1V270)