A PHASE 1 STUDY OF TJ033721 IN SUBJECTS WITH ADVANCED OR METASTATIC SOLID TUMORS
The purpose of this study is to test the safety of a study drug called TJ033721. The study will test different dose levels to find out what effects, both good and/or bad, the study treatment has on you and your solid tumor. The study drug, TJ033721, is investigational and has been tested in animals, but not yet in people. This means it has not been approved for commercial use by the United States Food and Drug Administration (FDA).This study tests up to 8 different doses of the study drug to see which dose is safe in people. The dose you receive will depend on when you start the study. The study drug’s effects will be measured by testing samples of your blood, scanning your tumor area, and in some cases taking a biopsy of your tumor. The study staff will also watch for physical changes after you are given the study drug.
A Phase 1 Trial Investigating LY4101174 an Antibody-Drug Conjugate Targeting Nectin-4 in Participants with Recurrent Advanced or Metastatic Solid Tumors
This is a study looking at a new medicine called LY4101174. The study team wants to see if it has few effects and how well it works in treating the cancer in patients with advanced or metastatic cancers, including urothelial carcinoma. The study has two parts. In the first part, the study team will test different amounts of LY4101174 to find the dose with the fewest side effects for the next part of the study. The study team will also check if there is a need to adjust the dose based on side effects if there are any. The second part will involve more patients, and they will use the best dose with few side effects found in the first part. The study will focus on different types of cancers like breast, lung, ovarian, and other cancers. The study team wants to understand how this medicine works and if it helps patients with treating these cancers.
A Phase 1/1b Open-label Multicenter Study to Investigate the Safety Tolerability Pharmacokinetics and Antitumor Activity of KIN-2787 in Participants with BRAF and/or NRAS Mutation-positive Solid Tumors
This is a 2-part, open-label, multicenter, dose escalation and dose expansion study in participants with rapidly accelerated fibrosarcoma, homolog B (BRAF) mutation-positive and/or neuroblastoma RAS (NRAS) mutation-positive tumors designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of KIN-2787, a pan-rapidly accelerated fibrosarcoma (RAF) small molecule kinase inhibitor; to determine a recommended Phase 2 dose (RP2D) of KIN-2787 for further clinical development; and to assess the objective response to KIN-2787 therapy alone and in combination with binimetinib, a mitogen-activated protein kinase (MEK) inhibitor.
A Phase 1/1b Study of ASP2138 in Participants With Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma or Metastatic Pancreatic Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression
Claudin 18.2 protein, or CLDN18.2 is a protein found on cells in the digestive system. It is also found on some tumors. Researchers are looking at ways to attack CLDN18.2 to help control tumors. ASP2138 is thought to bind to 2 targets at the same time: CLDN18.2 and a protein called CD3 found on immune cells, called T-cells. ASP2138 works by binding to both the tumor cell and CD3 which "tells" the immune system to attack the tumor.ASP2138 is a potential new treatment for people with stomach cancer, gastroesophageal junction cancer, (cancer where the tube that carries food (esophagus) joins the stomach) or pancreatic cancer. Before ASP2138 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. This information will help to find a suitable dose and to check for potential medical problems from the treatment.Adults 18 years or older with stomach cancer, gastroesophageal junction cancer, or pancreatic cancer can take part. Their cancer is locally advanced unresectable or metastatic. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body.The main aims of the study are to check the safety of ASP2138, how well it is tolerated, and to find a suitable dose of ASP2138 to be used later in this study.This is an open-label study. This means that people in this study and clinic staff will know that people will receive ASP2138.The study will have 2 phases. In phase 1, different small groups of people will receive lower to higher doses of ASP2138. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP2138 to use later in the study. The first group will receive the lowest dose of ASP2138. A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP2138. The panel will do this for each group until all groups have received ASP2138, or until suitable doses have been selected for later in the study. Doctors will also check how each type of cancer is responding to ASP2138.In phase 1b, other different small groups will receive suitable doses of ASP2138 found from phase 1. This phase will check how each type of cancer responds to ASP2138. The response to ASP2138 is measured using scans and blood tests. Doctors will continue to check all medical problems throughout the study.ASP2138 will be given through a vein in the arm. This is called an infusion. People will receive weekly infusions of ASP2138 in a 14-day (2-week) treatment cycle. People will continue to receive treatment until: their cancer gets worse; they have medical problems they can't tolerate; they ask to stop treatment; the doctors decide that continuing treatment is no longer in that person's best interest; the study is ended by the sponsor. Doctors will check if people had any medical problems from ASP2138. Other checks will include medical examinations, checking the nervous system, blood and urine tests and vital signs. Nervous system checks include checking peoples state of mind, reflexes, balance, movement and muscle strength. Vital signs include medical examinations, body temperature, breathing rate, and blood oxygen levels. Electrocardiograms (ECG) will be done to check the heart rhythm during the study. People will receive ASP2138 in a hospital. They will have blood tests and doctors will check for medical problems. People will also visit the clinic on certain days during their treatment, with extra visits during the first 3 cycles of treatment.People will visit the clinic after treatment has finished. The doctors will check for more medical problems. Other checks will include medical examinations, blood and urine tests, and vital signs. People will also have an ECG.After this, people will visit the clinic for a check-up several times. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their treatment or not.
A Phase 1/2 First-in-Human Open-Label Dose Escalation Study of Talquetamab a Humanized GPRC5D x CD3 Bispecific Antibody in Subjects with Relapsed or Refractory Multiple Myeloma
This is a Phase 1/2 first-in-human (FIH) study of the humanized immunoglobulin G4 proline, alanine, alanine (IgG4 PAA) bispecific antibody, talquetamab, which was developed to evaluate the therapeutic potential of targeting GPRC5D for T cell redirection. The antibody binds to the CD3 receptor complex on T cells and to GPRC5D on plasma cells. It is hypothesized that by inducing enhanced T cell-mediatedcytotoxicity through recruitment of CD3-expressing T cells to the GPRC5D-expressing cells, treatment with talquetamab will be an effective therapy for subjects with multiple myeloma.Part 1 and Part 2 of the study are considered Phase 1; Part 3 of the study is considered Phase 2. Part 1 and Part 2 will enroll subjects with relapsed or refractory multiple myeloma. Part 3 will enroll subjects with relapsed or refractory multiple myeloma in the following 2 cohorts that differ by prior therapy:? - Cohort A will enroll subjects with multiple myeloma who have previously received =3 prior lines of therapy that included at least one proteasome inhibitor (PI), one immunomodulatory imide drug (IMiD), and an anti-CD38 monoclonal antibody, and have not been exposed to T cell redirection therapies such as CAR-T or bispecific antibodies.? - Cohort B will enroll subjects with multiple myeloma who have previously received =3 prior lines of therapy that included at least one PI, one IMiD, and an anti-CD38 monoclonal antibody, and have been exposed to T cell redirection therapies such as CAR-T or bispecific antibodies.
A Phase 1/2 First-Time-in-Human open-label multicenter dose escalation and expansion study of the oral DNA Helicase Werner Inhibitor (WRNi) GSK4418959 alone or in combination with other anti-cancer agents in adult participants with Mismatch Repair-deficient (dMMR) or Microsatellite Instability-High (MSI-H) solid tumors (SYLVER)
This study will test how well the oral WRN inhibitor GSK4418959 works and whether it has few side effects, both by itself and with dostarlimab, in patients with advanced cancers that have specific genetic markers called dMMR/MSI-H, including colorectal and endometrial cancer. First, patients will go through a pre-screening process to check if their tumors have these markers and see if they qualify. Those who qualify will join one of three parts of the study: Part 1 will test different doses of GSK4418959 alone in patients with advanced tumors; Part 2 will use the best dose from Part 1 to test the drug in patients with advanced colorectal or endometrial cancer; and Part 3 will test different doses of GSK4418959 combined with dostarlimab in patients with advanced tumors.
A Phase 1/2 Multicenter Open-Label Study to Evaluate the Safety Tolerability and Preliminary Antitumor Activity of TNG456 Monotherapy and in Combination with Abemaciclib in Patients with Solid Tumors with MTAP Loss
This study is testing a new medicine, TNG456, alone and with another medicine called Abemaciclib, to find the dose that works well and has fewer side effects for patients with solid tumors with loss of the MTAP gene or MTAP protein who have tried other standard treatments before. This study has two parts. In the first part, the study team will find out the most effective dose of TNG456 with fewer side effects by testing different doses of the study medicine. The doctors will gradually increase the dose of TNG456 while looking closely for the side effects. In the second part, more patients will be included to get the most effective dose found in the first part of the study. All patients will have their blood samples taken to see how they are doing and how their bodies are handling the medicine. The patients will have special scans taken at different times throughout the study. The doctors will evaluate the results and outcomes to learn how the medicine changes the tumor. All the patients will be closely monitored for discomfort and side effects throughout the study.
A Phase 1/2 Multicenter Open-Label Study to Evaluate the Safety Tolerability and Preliminary Antitumor Activity of TNG462 in Combination with Other Agents in Patients with Pancreatic or Non-Small Cell Lung Cancer with MTAP Loss and RAS Mutation
This Phase 1/2 study will determine the safety, tolerability, PK, PD, and preliminary antineoplastic activity of oral TNG462 in combination with RMC-6236 or RMC-9805.Overall, the study comprises a dose escalation phase and a dose expansion phase.
A Phase 1/2 Multiple Expansion Cohort Trial of MRTX1719 in Patients with Advanced Solid Tumors with Homozygous MTAP Deletion
This study is testing the effectiveness of a new drug, MRTX1719, in patients with advanced solid tumors that have a specific genetic change called MTAP deletion. The study follows guidelines from the U.S. Food and Drug Administration (FDA). The study starts with Phase 1, which will test different doses of MRTX1719 to find the most effective one with less sideeffects. In Phase 2, MRTX1719 will be tested in different groups of patients based on their type of cancer and other characteristics to see how well the drug works and how safe it is. There are plans to make changes during the study to prepare for future tests, depending on the results. The study includes careful monitoring, genetic testing to confirm eligibility, andregular checks on how the drug affects the patients.
A Phase 1/2 open label first-in-human dose escalation and expansion study for the evaluation of safety pharmacokinetics pharmacodynamics and anti-tumor activity of SAR445877 administered as monotherapy or in combination with other anticancer therapies in adults with advanced solid tumors
This is an open-label, multi-center study testing whether the study medicine, SAR445877, (new fusion protein combining anti-programmed cell death 1 (PD1) antibody with modified interleukin (IL)15) is safe and has fewer side effects as a treatment alone or when given with other medicines for adult patients with solid tumors that have spread from their primary location. This study has two parts- For part 1, patients with solid tumors that have spread to other parts of their body and who have no alternative treatment options for their cancer will receive the study medicine every 2 weeks or weekly, together with other medicines decided by the study doctor. For part 2, patients will be divided into nine groups based on the type of their cancer. This group of patients will receive the study medicine at the dose that was found to be most effective and with fewer side effects in part 1 of the study, along with the medicine called cetuximab (EGFR antibody). All patients will have their blood samples taken to see how their bodies are handling the study medicine and to check if they are doing well. All patients will have special scans taken to see how the study medicine is changing their cancer. All patients will be closely monitored for safety and side effects.