Ithaca

This research aims to evaluate the KnowHow program, a 10-week digital intervention designed to promote healthy eating and activity behaviors among families with young children. The study focuses on assessing how feasible and acceptable this program is for parents of preschool-aged children, including how well families engage with the program and their intentions to continue its practices. The intervention targets health behavior improvements in early childhood by providing parent education on mindful parenting, nutrition, and physical literacy. The KnowHow program includes three main components a custom mobile app delivering educational content and activities, virtual group discussions held via Zoom, and child-centered support materials mailed to families. The app is organized into five modules containing lessons, activities, and assessments focused on mindful parenting, healthy eating, and physical activity. Two groups are studied one receives the 10-week intervention, and a delayed control group does not receive the program during the study period but gains access afterward. Participants will be assessed at baseline week 0 and after the 10-week intervention post-test for several outcomes including recruitment, retention, usability, acceptability, digital engagement, and intention to sustain behaviors. Behavioral outcomes such as mindful parenting, parent-child feeding practices, and physical activity parenting practices are measured before and after the intervention. Parent self-efficacy and behavioral skills are also evaluated. The total study duration for participants is 10 weeks, with no additional assessments for the control group after the intervention period.

Researchers are evaluating the safety, tolerability, and preliminary effectiveness of IMP1734, a PARP1 selective inhibitor, in people with advanced solid tumors. This study includes patients with breast cancer, metastatic prostate cancer, ovarian cancer, and other solid tumors who have previously received certain treatments. The goal is to find an optimal dose for future clinical development by studying how the drug affects the body and how the body processes it. The study has two parts Part 1 involves gradually increasing doses of IMP1734 given as a daily oral tablet to identify the highest safe dose or maximum achievable dose. This includes testing the drug alone and in combination with other treatments for specific cancers like metastatic prostate, ovarian, and breast cancer. Part 2 focuses on refining the dose to find the best amount for future studies. Treatment can last up to three years after the first dose. Participants will be monitored closely with assessments of side effects, blood tests to study drug levels and effects, and evaluations of tumor response using standard criteria. Safety monitoring continues up to 30 days after the last dose. Researchers measure how well the drug is tolerated and its impact on the cancer over time. The total participation may extend up to three years, with ongoing evaluations during this period.

Researchers are conducting a master protocol study to evaluate the long-term safety and efficacy of the drug pirtobrutinib in patients who have completed previous clinical studies involving this medication. This study includes participants with chronic lymphocytic leukemia or non-Hodgkin lymphoma and aims to monitor their health over an extended period. The master protocol organizes individual study-specific appendices ISAs representing participants from earlier originator studies. Participants continue to receive pirtobrutinib as they did in their original clinical study, with the drug administered orally. The study allows these individuals to keep taking the treatment or to continue with follow-up visits under this master protocol framework. The study is designed to gather safety and survival data over many years. During the study, participants will be closely monitored for any serious treatment-related side effects, with assessments focused on adverse events occurring from the first dose until shortly after the last dose or when starting a new anticancer therapy. Researchers will also track overall survival for up to 93 months. This long-term follow-up ensures comprehensive safety and health evaluations throughout the participants involvement, which may last several years.

This research aims to assess the long-term safety and effectiveness of pirtobrutinib in people who have previously been treated for Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Non-Hodgkin Lymphoma. It is a Phase 4 study involving participants who completed an earlier study called LOXO-BTK-18001. The study invites these participants to continue their assigned treatment or follow-up in this extension study. Participants will continue receiving pirtobrutinib, which is taken orally, as they did in the original study. This study serves as an individual-study appendix under the master protocol J2N-MC-JZNY. There are no new treatment groups participants maintain the therapy they were assigned before. During the study, participants will be monitored for serious treatment-related side effects, including tracking any grade 3 or higher adverse events occurring from the first dose through 30 days after the last dose or until starting a new cancer therapy. Researchers will also observe overall survival up to 93 months from enrollment in the original study. Participants will have regular follow-up visits to assess their health and treatment safety over the long term.

Researchers are evaluating MCLA-158, a bispecific antibody targeting EGFR and LGR5, in patients with advanced solid tumors, including metastatic colorectal cancer mCRC and head and neck squamous cell carcinoma HNSCC. This Phase 12 open-label study aims to determine the recommended Phase II dose RP2D and assess the safety, tolerability, pharmacokinetics, immunogenicity, and anti-tumor activity of MCLA-158 alone or combined with other therapies. The dose escalation phase has been completed, and expansion cohorts are ongoing for selected tumors with EGFR dependency. Participants receive MCLA-158 either as a single agent or in combination with pembrolizumab or chemotherapy regimens FOLFIRI or FOLFOX. The single-agent dose is administered intravenously every two weeks in 28-day cycles. The study includes various cohorts, some closed and others actively enrolling, evaluating different doses and formulations, including a subcutaneous version. Combination therapies are explored mainly in mCRC and HNSCC patients at different treatment lines. During the study, participants undergo regular assessments including safety monitoring, laboratory tests, cardiac evaluations, and tumor response measurements over periods ranging from weeks to months. Researchers track dose-limiting toxicities, adverse events, pharmacokinetic markers, and anti-tumor efficacy using standardized criteria. Follow-up extends up to 36 months to observe long-term outcomes, treatment discontinuations, and antibody responses, ensuring comprehensive evaluation of MCLA-158s profile.

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Researchers are studying NX-5948, an oral drug, in adults with relapsed or refractory B-cell malignancies, including various lymphomas and leukemias such as Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Diffuse Large B-cell Lymphoma, and others. This Phase 1a1b open-label trial aims to assess the safety, tolerability, and anti-cancer activity of NX-5948 in patients who have received prior treatments and have limited options. The study includes multiple cohorts focusing on different types of B-cell cancers and specific patient characteristics. The study has two main parts Phase 1a dose escalation to determine the maximum tolerated dose and recommended dose for further study, followed by Phase 1b safety expansion and cohort expansion to evaluate the drugs anti-tumor activity at selected doses across various patient groups. Participants receive oral NX-5948 at different dose levels, with some groups randomized to compare doses. The treatment targets a range of B-cell malignancies, including those affecting the central nervous system. Participants are closely monitored throughout the study for dose-limiting toxicities, adverse events, and anti-tumor responses using established criteria. Assessments include measuring overall response rates, pharmacokinetics, pharmacodynamics, and survival outcomes over periods lasting up to several years. The study involves regular visits for safety and efficacy evaluations, and participants organ and bone marrow functions are monitored to ensure suitability for treatment.

This research aims to evaluate the long-term safety of pirtobrutinib in people who have previously been treated for chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL. It offers continued access to the study drug or follow-up for participants who completed a prior related study LOXO-BTK-20020. The study is designed to observe and monitor safety outcomes over an extended period. Participants receive either pirtobrutinib or idelalisib orally as part of the study treatments. These medications are taken every four weeks. The study is expected to last about five years, allowing researchers to collect long-term safety data on these treatments in a parallel group setup. Throughout the study, participants will have regular visits to monitor their health and any treatment-related effects. Researchers will track the percentage of participants experiencing serious treatment-emergent adverse events. They will also observe overall survival from the original study enrollment. Safety monitoring will continue up to 30 days after the last dose or until new anticancer therapy begins, ensuring careful follow-up for each participant.

Researchers are evaluating whether adding sacituzumab tirumotecan to pembrolizumab after surgery improves treatment outcomes for adults with resectable non-small cell lung cancer NSCLC who do not achieve a complete response after initial therapy. This Phase 3 trial compares the combination of sacituzumab tirumotecan plus pembrolizumab against pembrolizumab alone, focusing on disease-free survival assessed by a blinded independent central review. The study is sponsored by Merck Sharp & Dohme LLC and targets participants with specific stages of NSCLC who have undergone neoadjuvant therapy and surgery but still have residual disease. Participants first receive neoadjuvant therapy consisting of pembrolizumab combined with double-platinum chemotherapy tailored to the tumor type for up to 12 weeks before surgery. After surgery, those not achieving pathological complete response are assigned to either receive sacituzumab tirumotecan infusions every two weeks for up to 24 weeks alongside pembrolizumab monotherapy every six weeks for approximately 42 weeks, or pembrolizumab monotherapy alone on the same schedule. Rescue medications to manage infusion reactions may be given as needed during the study. Throughout the trial, participants undergo assessments including radiological scans, tumor tissue analysis for markers like PD-L1 and TROP2, and monitoring for adverse events and quality of life changes. Key outcomes include disease-free survival, overall survival, distant metastasis-free survival, and lung cancer-specific survival, with evaluations continuing for up to nearly 10 years. Safety and tolerability are closely monitored, and questionnaires assess physical functioning, symptoms like cough and chest pain, and overall health status during and after treatment.

Researchers are evaluating the safety, tolerability, and effects of NDI-219216 in patients with advanced solid tumors, including those with or without microsatellite instability and deficient mismatch repair. This early phase 12 study aims to understand how NDI-219216 affects tumor size, its side effects, and its impact on the body. The trial is sponsored by Nimbus Wadjet, Inc. and includes patients whose tumors are advanced and have not responded to standard treatments or for whom no standard options exist. The study involves three parts Part A focuses on dose escalation where patients receive increasing doses of NDI-219216 daily in 28-day cycles to find the best dose. Part B randomizes patients into up to three dose groups determined from Part A to further evaluate the treatment daily in 28-day cycles. Part C enrolls patients with specific tumor biomarkers dMMRMSI-H using the optimal dose from Part B. Participants take NDI-219216 orally every day throughout these cycles. Participants visit the clinic six times during the first 28-day cycle, twice in the second cycle, and then monthly for checkups and tests while on treatment. After finishing treatment, there is an end-of-treatment visit and a follow-up that can be done by phone. Patients keep a diary to track their tablet intake and any symptoms. Researchers assess safety by monitoring side effects, tumor response using imaging criteria, and measure drug levels in the blood at scheduled times during the first treatment cycle. The study may last up to 17-18 months depending on the part of the trial.