Ithaca

Researchers are evaluating the Know-How program, a 10-week digital intervention designed to promote healthy eating and activity behaviors in families with young children. This pilot study aims to assess how feasible and acceptable the program is for parents, focusing on mindful parenting, nutrition, and physical literacy. The study includes families with preschool-aged children and investigates how the program supports creating healthy environments and behaviors. The intervention includes three main parts: a custom mobile app that offers lessons, activities, and assessments across five modules; virtual group discussions held via Zoom; and child-centered support materials mailed to the families. The app provides education on mindful parenting, healthy eating, and physical literacy, along with strategies to incorporate these into daily life. Families engage with content designed to involve both parents and preschool-aged children throughout the 10-week period. Participants will be assessed before and after the intervention using surveys and measures that look at recruitment, retention, usability, acceptability, digital engagement, and intentions to maintain healthy behaviors. The study also evaluates parent self-efficacy, behavioral skills, and parenting practices related to feeding and physical activity. Data collection occurs at baseline and post-intervention to understand changes and outcomes related to the program.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of IMP1734, a PARP1 selective inhibitor, in participants with advanced solid tumors. The study aims to assess preliminary efficacy and find the best dosing for future clinical development. This first-in-human trial is conducted in two parts, focusing on patients with recurrent, advanced, or metastatic solid tumors including metastatic prostate, ovarian, breast, and other solid tumors with specific genetic mutations. The trial has two main phases: Part 1 involves dose escalation of IMP1734 as a monotherapy to determine the maximum tolerated or achievable dose in solid tumors. Part 2 focuses on dose optimization to select the optimal dose for further clinical use. Treatment involves oral administration of IMP1734, with dose escalation steps and combination dose escalations in specific cancers like metastatic prostate cancer, ovarian, and breast cancer. Participants will undergo regular assessments to monitor safety through adverse event tracking, pharmacokinetic and pharmacodynamic evaluations, and tumor response measurements using criteria like RECIST1.1, CA125, or PSA. The study includes monitoring for serious adverse events from consent until 30 plus 7 days after the last dose. Dose-limiting toxicities are assessed during the first treatment cycle. Participants are expected to have adequate organ function, a life expectancy of at least 12 weeks, and will be followed closely during the trial to evaluate the drug's safety and potential anti-tumor activity.

This research aims to evaluate the long-term safety and effectiveness of pirtobrutinib in patients with Chronic Lymphocytic Leukemia or Non-Hodgkin Lymphoma. It uses a master protocol design that includes participants from previous clinical studies (called originator studies) of pirtobrutinib. These participants can continue treatment or follow-up as part of this ongoing evaluation. Participants receive pirtobrutinib orally, continuing from their prior originator studies. The master protocol oversees individual study-specific appendices (ISAs) that include these participants, allowing for a structured and continuous assessment of the treatment's long-term use. During the study, researchers monitor the occurrence of significant treatment-related adverse events from the first dose until 30 days after the last dose or the start of a new anticancer therapy. This includes tracking and evaluating safety outcomes to better understand the long-term effects of pirtobrutinib in these patient populations.

Study J2N-MC-JZ01 evaluates the long-term safety and efficacy of the drug pirtobrutinib in participants who have previously been treated for Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Non-Hodgkin Lymphoma. This study serves as an extension for participants from the completed originator study LOXO-BTK-18001, allowing them to continue their assigned treatment or follow-up visits. It is a Phase 4 study focused on monitoring ongoing outcomes after initial treatment phases. Participants receive pirtobrutinib orally as part of the study intervention. The study allows participants to transition seamlessly from the originator study to continue either treatment or follow-up. This design supports long-term observation of the drug's effects beyond the initial trial period. During the study, researchers will monitor participants for treatment-emergent adverse events of Grade 3 or higher, tracking safety from the first dose through 30 days after the last dose or until a new anticancer therapy begins. The total duration depends on each participant's treatment and follow-up schedule. Regular assessments will help evaluate the drug's safety profile and ongoing efficacy.

Researchers are evaluating MCLA-158, a bispecific antibody targeting EGFR and LGR5, in patients with advanced or metastatic solid tumors such as metastatic colorectal cancer (mCRC) and head and neck squamous cell carcinoma (HNSCC). This Phase 1/2, open-label, multi-center, and multi-national study includes an initial dose escalation phase that has been completed to find the recommended Phase II dose (RP2D) of MCLA-158. The study further explores the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and anti-tumor activity of MCLA-158 alone or combined with other treatments in selected solid tumor types dependent on EGFR signaling. The study involves several parts: a dose escalation phase to determine the RP2D of MCLA-158 as a single agent, followed by dose expansion cohorts where MCLA-158 is given at 1500 mg every two weeks either alone or in combination with other therapies. Combination treatments include MCLA-158 with pembrolizumab, FOLFIRI chemotherapy, or FOLFOX chemotherapy in different patient groups. Expansion cohorts focus on patients with advanced head and neck cancer or metastatic colorectal cancer, with some cohorts closed and others currently enrolling. Participants will undergo tumor biopsies, imaging scans, and laboratory tests to assess measurable disease and organ function, along with safety and treatment response monitoring over months to years. Researchers will track adverse events, dose modifications, treatment discontinuations, response rates, and exposure-safety relationships. The study includes long-term follow-up up to 36 months to evaluate overall treatment outcomes and safety in this patient population.

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

Researchers are evaluating the safety and anti-cancer activity of NX-5948, an oral Bruton's Tyrosine Kinase (BTK) degrader, in adults with advanced B-cell malignancies. This Phase 1a/1b open-label study focuses on patients with relapsed or refractory B-cell cancers who have received prior therapies and for whom no other beneficial treatments are known. The study includes multiple types of B-cell cancers such as Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Diffuse Large B-cell Lymphoma (DLBCL), Mantle Cell Lymphoma (MCL), and others, including those with central nervous system involvement. In Phase 1a, the study escalates doses of NX-5948 to assess its safety and tolerability in patients with various B-cell malignancies who have specific prior treatment histories. Phase 1b Part 1 expands safety and evaluates anti-tumor activity at selected doses across up to 17 patient groups with different B-cell cancers. Part 2 further explores anti-tumor effects in an additional group of CLL/SLL patients at the selected dose. Treatment involves oral administration of NX-5948, with patients possibly randomized to different dose levels to find the optimal dosing. Participants will undergo regular assessments including monitoring for side effects, tumor response evaluations through clinical and laboratory tests, and tracking of adverse events over months to years. Key measures include dose-limiting toxicities, overall response rates, and safety outcomes such as serious adverse events and treatment discontinuations. The study aims to establish maximum tolerated doses and long-term safety while observing the drug's activity against B-cell cancers over up to six years of follow-up.

This research aims to evaluate the long-term safety of pirtobrutinib in adults who have previously been treated for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It focuses on participants who completed a prior study (J2N-MC-JZNN/LOXO-BTK-20020) and offers them continued access to the study drug or follow-up visits. The study is in Phase 4 and targets assessing safety outcomes over an extended period. Participants will receive pirtobrutinib orally every four weeks. The study includes treatment administration and ongoing follow-up for about five years, allowing researchers to monitor the long-term effects of the drug. Idelalisib is also listed as an intervention but the study primarily assesses pirtobrutinib. Throughout the study, researchers will monitor participants for any treatment-emergent adverse events of grade 3 or higher from the first dose until 30 days after the last dose or start of new anticancer therapy, whichever occurs first. Participants will be regularly assessed during their visits to ensure safety and collect necessary data over the duration of the study.

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 have not achieved a complete response after initial therapy. This Phase 3 study compares the combination of sacituzumab tirumotecan and pembrolizumab to pembrolizumab alone, focusing on disease-free survival as measured by a blinded independent central review. Participants receive neoadjuvant treatments including pembrolizumab with platinum-based doublet chemotherapy (such as cisplatin, pemetrexed, gemcitabine, carboplatin, or paclitaxel) before surgery. After surgery, those without a complete pathological response are randomized to receive either sacituzumab tirumotecan every two weeks for up to 24 weeks plus pembrolizumab every six weeks for up to 42 weeks, or pembrolizumab alone. Rescue medications may be given to prevent infusion reactions and oral side effects. During the study, participants undergo regular radiological assessments and provide tumor tissue samples to evaluate markers like PD-L1 and TROP2. Researchers monitor disease-free survival for up to approximately 93 months. Safety assessments, recovery from previous therapies, and control of infections such as HIV or hepatitis are also part of participant evaluations throughout the study period.

Researchers are evaluating the safety, tolerability, and potential effectiveness of NDI-219216, a selective small molecule inhibitor of WRN helicase activity, in patients with advanced solid tumors, including those with microsatellite instability-high (MSI-H) cancer. This first-in-human, Phase 1/2 open-label study aims to assess the drug's safety, how it behaves in the body, and its preliminary effects on tumor size. The study focuses on patients whose tumors are unresectable or metastatic and have not responded to or cannot tolerate standard treatments. Participants will take NDI-219216 orally every day. The study includes dose escalation, optimization, and expansion phases to find the appropriate dose and evaluate effects. During the first 28-day cycle, patients will visit the clinic six times, then two visits in the second cycle, followed by monthly checkups while on the study. There is also an end of treatment visit, and after the study ends, follow-up may be done by phone. Throughout the study, participants will keep a diary to record tablet intake and any symptoms experienced. Researchers will monitor adverse events and serious adverse events for up to 11 to 18 months depending on the study part, assess tumor response using imaging criteria, and evaluate treatment safety and effectiveness. Each treatment cycle lasts 28 days, and overall participation may last close to a year or more depending on response and study phase.