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.
A Phase 1/2 Open-Label Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of TNG260 as Single Agent and in Combination with an anti-PD-1 Antibody in Patients with STK11-Mutated Advanced Solid Tumors
This is a first-in-human Phase 1/2, open-label, multicenter, dose-escalation and -expansionstudy designed to determine the MTD of TNG260 as single agent and in combination withpembrolizumab, to determine the RP2D(s) of the combination, and to evaluate the safety andtolerability, PK, and antineoplastic activity of escalating oral doses of TNG260 whenadministered alone and with a standard dose of pembrolizumab in participants with locallyadvanced or metastatic STK11-mutated solid tumors who have progressed on at least 1 lineof standard therapy or are ineligible for standard therapies.In Phase 1 (dose escalation), at least 3 DLT-evaluable participants will be enrolled insequentially escalating dose cohorts to determine the MTD of single agent TNG260, theMTD of the combination of TNG260 and pembrolizumab, and the RP2D(s) of TNG260 incombination with a standard dose of pembrolizumab. The dose escalation of TNG260 will beguided by two BLRMs based on any DLTs observed in the first cycle (ie, the first 21 days) ofthe single agent therapy and the second cycle for the combination therapy.Participants in Phase 2 (dose expansion) will be dosed at the RP2D(s) determined fromPhase 1 based on demonstrated tolerability, together with available PK data and results oftarget engagement studied during Phase 1 (or other measures including PD and efficacy), asapplicable. Three Phase 2 combination expansion arms (TNG260 in combination withpembrolizumab) will enroll up to approximately 30 participants each.
A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Olomorasib Combination Therapy in Metastatic NSCLC KaRAnaSa (ISA-4)
This is a study in which patients have a specific change in their cancer cells called a KRAS G12C mutation, which means one tiny part of a gene (KRAS) has been changed in a way that may cause the cancer to grow. In this study, two medicines, Amivantamab and Olomorasib, are used together to treat this type of lung cancer (KRAS G12C-mutated metastatic NSCLC). Amivantamab is a special type of antibody that blocks two cancer related proteins (EGFR and MET) to stop cancer cell signaling. Olomorasib is an experimental medicine that blocks the KRAS G12C protein in cancer cells. This study consists of two parts: part one (combination dose selection) and part two (expansion). In Part one of the study, patients will be given the two medicines together to find the safest and most effective dose. Part two will see how well the two medicines work at the chosen dose to fight the cancer and slow down or prevent the growth of tumors. All patients will have frequent medical check ups and blood samples taken to see how their bodies are handling the study medicine. The study team will have special scans done for all patients to see how the cancer isresponding to the study medicines. The study team will be monitoring the patients for potential side effects and safety concerns.
A Phase 1/2 Study of LY3537982 in Patients with KRAS G12C-Mutant Advanced Solid Tumors
Study LOXO-RAS-20001 is a first-in-human, multicenter, open-label Phase 1/2 study to evaluate the safety, tolerability, and preliminary efficacy of oral LY3537982 as monotherapy and as part of combination therapy in patients with KRAS G12C-mutant advanced solid tumor types, including but not limited to NSCLC and CRC.This study includes 2 parts, Phase 1a dose escalation (Part A) followed by a Phase 1b dose expansion (Part B-E). The Phase 1a dose escalation LY3537982 monotherapy cohort will enroll any eligible patient with KRAS G12C-mutant advanced solid tumor. Once the LY3537982 monotherapy RP2D (RP2DM) is established, Phase 1b dose expansion will begin and include 10 cohorts (NSCLC, Cohorts B1–B6; CRC, Cohorts C1–C2; other solid tumors [except NSCLC and CRC], Cohort D1; KRAS G12C-mutant advanced NSCLC who have previously been treated with a KRAS G12C inhibitor, Cohort E1) to further evaluate safety and clinical activity.KRAS G12C mutations will be identified through standard of care testing as routinely performed at each participating site utilizing material collected prior to patient consent to this protocol. Molecular assays utilized for enrollment are required to be performed in Clinical Laboratory Improvement Amendments (CLIA), International Organization for Standardization/International Electrotechnical Commission (ISO/IEC), College of American Pathologists (CAP), or other in a similarly certified laboratory.
A Phase 1/2 Study to Evaluate the Safety and Efficacy of AZD0486 in Adolescent and Adult Participants with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukaemia
This study is designed to test how effective a new drug called AZD0486 (BITE for CD19) is for patients relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) who have already tried at least 1-2 other treatments. This study has three parts: Part A will test increasing doses of AZD0486 to find a dose with few side effects; Part B will test up to two doses from Part A to decide the best dose to use in the next phase; and Part C will use the best dose from Part B to see how well it works in more patients. AZD0486 will be given as an IV infusion on certain days of each 28-day cycle, with close monitoring for side effects. Side effects and effectiveness will be checked regularly, and the study will continue untilenough data is collected to understand how well AZD0486 works and how safe it is.
A Phase 1/2 Study to Evaluate the Safety and Efficacy of MK-2870 Monotherapy or in Combination With Other Anticancer Agents in Gastrointestinal Cancers
This study is testing a new cancer treatment called MK-2870 to see if it has few side effects and works well for patients with certain types of gastrointestinal (GI) cancers. Patients will join the study and be placed into one of three groups based on their type of cancer: patients with colorectal cancer (CRC), patients with pancreatic cancer (PDAC), and patients withbiliary tract cancer (BTC). The study will check for side effects and see how well the treatment helps shrink tumors. For the CRC group, the study will first test the safety and side effects of MK-2870 with another drug, a combination of 5-FU (5-fluorouracil) and LV (leucovorin), before moving on to see how well it works. Any side effects will be carefully tracked and reported.
A Phase 1/2 Study to Evaluate the Safety and Efficacy of Patritumab Deruxtecan (MK-1022) in Gastrointestinal Cancers
This is a Phase 1/2 study testing a new medicine HER3-DXd, also known as Patritumab Deruxtecan (antibody drug conjugate), in patients with Gastrointestinal cancers that have spread to other parts of the body. Patients will be divided into three groups based on their type of cancer. Group 1 will enroll patients with Colorectal cancer. Group 2 will enroll patients with Biliary tract cancer. Both these groups of patients will receive HER3-DXd medicine at a single dose level. Group 3 will enroll liver cancer (Hepatocellular carcinoma) patients who will be divided to receive different dose levels of the study medicine to find out the dose that works well and has fewer side effects. The study team will collect blood samples from all patients to see how their bodies are processing the study medicine and if they are doing well. Special scans will be taken from all patients to see how the tumor is responding to the study medication. Study doctors will perform genetic testing (biomarkers) on blood and tissue samples in the hope of further helping patients. All patients will be closely monitored for side effects and any safety concerns.
A Phase 1/2a Multicenter Open-Label First in Human Study to Assess the Safety Tolerability Pharmacokinetics and Preliminary Antitumor Activity of DB-1303 in Patients with Advanced/Metastatic Solid Tumors
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303 in subjects with advanced solid tumors that express HER2.