View clinical trials related to Advanced Solid Tumors.
Filter by:ASP2074 is a potential new treatment for people with certain solid tumors. Before ASP2074 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. This information will help find a suitable dose and check for potential medical problems from the treatment. People in this study will be adults with metastatic or locally advanced solid tumors. Metastatic means the cancer has spread to other parts of the body. They will have been previously treated with all available standard therapies and they may no longer be benefitting from further treatment. There are 2 main aims of this study. The first is to learn if people with certain solid tumors have any medical problems after receiving different doses of ASP2074. The second is to find a suitable dose of ASP2074 to use in future studies. This study will be in 2 parts. In Part 1, different small groups of people will receive lower or higher doses of ASP2074. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP2074 to use in Part 2 of the study. The first group will receive the lowest dose of ASP2074. A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP2074. The panel will do this for each group until all groups have taken ASP2074 or until suitable doses have been selected for Part 2. In Part 2, other different small groups of people will receive ASP2074 with the most suitable doses worked out from Part 1. This will help find a more accurate dose of ASP2074 to use in future studies. ASP2074 will be given as an infusion on the first day of each treatment cycle. The people in this study will have treatment cycles until: they have medical problems from the treatment; their cancer gets worse; they start other cancer treatment; they ask to stop treatment; or they do not come back for treatment. People will visit the clinic on certain days during their treatment, with extra visits during the first 2 cycles of treatment. During these visits, the study doctors will check for any medical problems from ASP2074. At some visits, other checks will include a medical examination, laboratory tests and vital signs. Vital signs include temperature, pulse, and blood pressure. Also, blood and urine samples will be taken. Electrocardiograms will be done to check the heart rhythm during the study. Tumor samples will be taken during certain visits before treatment begins, during treatment, and when treatment has finished. People will visit the clinic within 7 days after stopping treatment. The study doctors will check for any medical problems from ASP2074. Other checks will include a medical examination, laboratory tests and vital signs. Then, people may visit the clinic at 30 days after stopping treatment. Thirty and 90 days after the last dose, the study doctors will check for any medical problems from ASP2074. People will have their vital signs checked and have some laboratory tests. After this, people will continue to visit the clinic every 6 weeks. This is to check the condition of their cancer. They will do this until their cancer is worse, they start other cancer treatment, they ask to leave the study, or they do not come back for treatment. Then, the study doctors will call every 12 weeks for up to 1 year or until that person asks to leave the study, the study is stopped, or the person cannot be reached.
The aim of this study is to assess the safety and tolerability of BMS-986360 as monotherapy and in combination with chemotherapy or nivolumab in participants with advanced solid tumors.
Objectives:To evaluate the safety and tolerability of BAT8008 for injection in patients with advanced solid tumors, explore the maximum tolerated dose (MTD), and provide the recommended dose for subsequent clinical trials.
Researchers are looking for a better way to treat people who have advanced solid tumors. Advanced solid tumors are types of cancer that may have spread to nearby tissue, lymph nodes, and/or to distant parts of the body and that are unlikely to be cured or controlled with currently available treatments. This study focuses on certain types of skin cancer, kidney cancer, stomach cancer, and lung cancer. The study treatment BAY2965501 is currently under development as monotherapy or in combination with a drug named pembrolizumab for the treatment of people with advanced solid tumors. BAY2965501 blocks an enzyme in T-cells to activate them. T-cells are a type of immune cell that are known to have an anti-cancer effect and BAY2965501 is a potential new immunotherapy. The main purpose of this first-in-human study is to learn: - how safe different doses of BAY2965501 are when given as a single drug or in combination, - the degree to which medical problems caused by BAY2965501 when given as a single drug or in combination, can be tolerated (also called tolerability), - what maximum amount can be given as a single drug or in combination, and - how it moves into, through and out of the body as a single drug or in combination. To answer this, researchers will look at: - the number and severity of medical problems participants have after taking BAY2965501 as a single drug or in combination for each dose level. These medical problems are also referred to as adverse events. - the (average) total level of BAY2965501 in the blood (also called AUC) after intake of single and multiple doses - the (average) highest level of BAY2965501 in the blood (also called Cmax) after intake of single and multiple doses Doctors keep track of all medical problems that participants have during the study, even if they do not think the medical problem might be related to the study treatment. In addition, the researchers want to know if and how the participants' tumors change after taking BAY2965501. The study will have two parts. The first part, called dose escalation, is done to find the most appropriate dose that can be given in the second part. For this, participants will be assigned to receive one of the planned doses and schedules of BAY2965501 as single drug or participants will be assigned to one of the increasing doses of BAY2965501 in combination with 200mg pembrolizumab. All participants will take BAY2965501 by mouth. Additionally, in the combination group, pembrozilumab will be given. In the second part, called dose expansion, all participants in the single drug group will receive up to 2 of the most appropriate doses of BAY2965501 from the 1st part as tablet by mouth. The participants in the combination group will receive the most appropriate dose of BAY2965501 from the first part. Participants in both parts of the study, will take the study treatment until the tumor gets worse (also known as 'disease progression'), or until the participants have medical problems. In general, the study treatment is planned for a maximum of 35 cycles. Each participant will be in the study for several months, including a screening phase of up to 28 days, few months of treatment depending on the participant's benefit, and a follow up phase after the end of treatment. The following approximate numbers of visits to the study site are planned: two during the screening phase, six in the first treatment month, one to three per month in the following periods. Participants in part two will be assigned to one of 3 groups depending on cancer characteristics. Study procedures described below may vary between these groups. During the study, the study team will: - take blood and urine samples - do physical examinations - check vital signs such as blood pressure, heart rate, body temperature - examine heart health using ECG (electrocardiogram) - check if the participants' cancer has grown and/or spread using CT (computed tomography) or MRI (magnetic resonance imaging) and, if needed, bone scan - take tumor samples (if required) The treatment period ends with a visit no later than 7 days after the last BAY2965501 dose in the single drug and combination group. About 30 and 90 days after the last dose and every 12 weeks thereafter, the study team will check the participants' health and any changes in cancer. This follow-up period ends with worsening of the cancer, start of new anti-cancer therapy, or until the participant leaves the study. In addition, the study doctors and their team will contact the participant every 12 weeks to learn about the participant's survival. This ends no later than 12 months after the last participant started treatment or by the end of the study, whichever comes first.
This is a first-in-human study with the SYHX2005 tablet primarily designed to evaluate the safety and tolerability of SYHX2005 at increasing doses in patients with advanced solid tumors and for whom no standard of care exists. The study will be conducted in two parts: Stage1 dose-escalation and Stage2 dose-expansion. In Stage1, patient enrolment will be proceeded according to a "Accelerated Titration + BOIN" design in order to identify the maximum-tolerated dose (MTD) or recommended dose. In Stage2, preliminary efficacy response will be assessed in patients with advanced solid tumors in use of the recommended dose.
This study is a multicenter, open-label, proof-of-concept study aiming to assess the clinical and biological impact of NP137 when added to standard PD-1/PD-L1 blockade therapy in 3 independent cohorts of advanced or metastatic solid tumors with various sensitivity to anti-PD-1/PD-L1: - Cohort 1 [Stable Disease]: Patients with a radiological documentation of SD according to RECIST V1.1 criteria following at least 12 weeks under standard anti PD-1/PD-L1 therapy. - Cohort 2 [primary refractory]: Patients with documented radiological PD according to RECIST V1.1 but with clinical benefit under anti PD-1/PD-L1 standard therapy. - Cohort 3 [secondary refractory]: Patients with documented radiological PD following an initial Objective Response according to RECIST V1.1, with clinical benefit under standard anti-PD-1/PD-L1.
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-706 as a monotherapy and in combination with budigalimab, carboplatin, or cisplatin. ABBV-706 is an investigational drug being developed for the treatment of small cell lung cancer (SCLC), high-grade central nervous system (CNS) tumors and high-grade neuroendocrine carcinomas (NECs). There are multiple treatment arms in this study. Participants will either receive ABBV-706 as a single agent or in combination with budigalimab (another investigational drug), carboplatin or cisplatin at different doses. Approximately 350 adult participants will be enrolled in the study across sites worldwide. In part 1 (dose escalation), ABBV-706 will be intravenously infused in escalating doses as a monotherapy until the maximum tolerated dose (MTD) is determined in participants with SCLC, high-grade CNS tumors, and high-grade NECs. In part 2, multiple doses will be selected from Part 1 and SCLC participants will be assigned to one of these doses in a randomized fashion to determine the recommended Phase 2 dose. In Part 3a, participants with SCLC or NECs will receive ABBV-706 in combination with budigalimab intravenously every 3 weeks. In Part 3b participants with SCLC or NECs will receive ABBV-706 in combination with either carboplatin or cisplatin intravenously. In Part 4a, participants with CNS tumors will receive ABBV-706 intravenously at a dose determined from Part 1. In Part 4b, participants with NECs will receive ABBV-706 intravenously at a dose selected from Part 1. The estimated duration of the study is up to 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.
This will be a Phase 1, multicenter, open-label trial to evaluate the safety, tolerability, PK and efficacy of ZN-A-1041 as a monotherapy or in combination in patients with HER2-positive advanced solid tumors with or without brain metastases. The study will consist of three phases: Phase 1a (dose escalation with ZN-A-1041 monotherapy), Phase 1b (dose escalation with ZN-A-1041 combination therapy) and Phase 1c (dose expansion with ZN-A-1041 combination therapy).
This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and preliminary clinical activity of STAR0602 as a single agent administered intravenously in participants with advanced solid tumors that are antigen-rich.
This is a Phase Ib, two-part, multi-center study. In Part 1, the study will evaluate the safety and tolerability, antitumor activity, pharmacokinetics, and determine the maximum tolerated dose (MTD) of 2X-121 monotherapy (at BID regimen) in patients with advanced solid tumors. In Part 2, the study will evaluate safety and tolerability, antitumor activity, pharmacokinetics and determine the MTD of dovitinib when given in combination with the MTD of 2X-121 determined in Part 1.