Kurralta Park

Researchers are evaluating the safety and effectiveness of three different doses of MORF-057 in adults with moderately to severely active Crohn's disease (CD). This Phase 2 study is randomized, double-blind, placebo-controlled, and conducted at multiple centers. It aims to compare MORF-057 to placebo to see how well it works in reducing disease activity and symptoms in this patient population. Participants will first go through a 14-week induction period where they receive one of three doses of MORF-057 or a matching placebo, all given orally. After this, all participants will enter a 38-week maintenance phase where they receive open-label MORF-057. Those who complete these 52 weeks of treatment may continue in a 52-week long-term extension to further monitor treatment effects and safety. Throughout the study, participants will have evaluations to assess their response to treatment using endoscopic scoring at Week 14. Researchers will monitor safety, symptom changes, and disease activity over the full treatment and extension periods. Study visits will include assessments, questionnaires, and clinical monitoring to track participants' health and treatment adherence over time.

Researchers are evaluating FMC-376 in adults with advanced solid tumors that have a specific KRAS G12C mutation. This trial aims to assess the safety, pharmacokinetics, and clinical effects of FMC-376 in patients whose tumors are locally advanced, unresectable, or metastatic. The study is conducted in three parts: Phase 1A (dose escalation), Phase 1B (dose expansion), and Phase 2 (cohort expansion), focusing on multiple dose levels in this patient population. Participants will receive FMC-376 as an oral capsule taken daily. The study explores different dosing schedules across the phases to determine optimal dosing and further evaluate the treatment's effects. The study is open-label, meaning both researchers and participants know which treatment is being administered. During the study, participants will be closely monitored for adverse events and dose limiting toxicities up to 21 days, with safety assessments continuing for approximately 24 months. Researchers will also assess pharmacokinetics and clinical activity of FMC-376. Participants must meet certain health and function criteria before and during the study to ensure safety and reliable results.

Researchers are evaluating the effectiveness and safety of pirtobrutinib in adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study focuses on two parts: Part 1 tests three different doses of pirtobrutinib in participants who have had 1 to 3 prior treatments, including a covalent Bruton tyrosine kinase (BTK) inhibitor. Part 2 evaluates pirtobrutinib alone in participants who have not received prior treatment but have a specific genetic deletion called 17p. This is a phase 2, open-label, randomized study. Pirtobrutinib is given orally to participants in both study parts. Participants in Part 1 receive one of three dose levels, while those in Part 2 receive pirtobrutinib monotherapy. Part 1 participation lasts about 3 years, and Part 2 participation can last up to 2 years. The study compares the effects of different doses and treatment histories to better understand pirtobrutinib’s impact on CLL/SLL. Throughout the study, researchers monitor participants' overall response to treatment from the start up to 3 years. They assess safety and side effects, and participants are required to be able to swallow oral medication and have a performance status that allows them to participate. The study includes regular evaluations to determine how well the treatment controls the disease and to track any adverse events over the course of the study periods.

Researchers are evaluating BGB-26808, alone or combined with tislelizumab, in participants with advanced solid tumors in an open-label, multicenter, nonrandomized Phase 1 study. This study aims to find the recommended dosing for BGB-26808 while assessing its safety, tolerability, pharmacokinetics, and early antitumor activity. Participants include those with advanced, metastatic, unresectable, or locally advanced tumors who may have limited treatment options or no prior therapy targeting HPK1. Participants receive BGB-26808 orally once daily as a tablet. Tislelizumab, when used, is given by intravenous infusion. Chemotherapy may also be administered following local guidelines or prescribing information. The study includes dose escalation and dose expansion phases to determine the maximum tolerated dose, maximum administered dose, and the recommended dose for further study. During the study, participants undergo regular monitoring for adverse events and serious adverse events up to about 12 months after dosing or until starting new anticancer therapy. Effectiveness is measured by overall response rate around 6 months. Researchers will collect tumor tissue samples, assess organ function, and evaluate performance status. Participants are followed closely with safety checks and evaluations of treatment response throughout the study duration.

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 studying the safety, tolerability, pharmacokinetics, immunogenicity, and early antitumor effects of MGC026 in adults with relapsed or refractory, unresectable, locally advanced, or metastatic solid tumors. This phase 1/1b study includes a dose escalation phase and a cohort expansion phase to better understand how MGC026 works and its safety profile in various advanced cancers such as lung, breast, ovarian, melanoma, and others. Participants will receive MGC026 through intravenous (IV) infusions. The initial dose is assigned when participants join the study, and they may receive up to 35 treatments as long as severe side effects do not occur and the cancer does not worsen. The study includes escalating doses in the dose escalation phase and a recommended dose in the expansion phase to find the best balance of safety and activity. Throughout the study, lasting up to 135 weeks, participants will be closely monitored for side effects and cancer progression. Blood samples will be collected regularly for routine lab tests and research purposes. Researchers will track adverse events, including serious ones and those causing dose changes or treatment stops, to evaluate the overall safety and tolerability of MGC026.

Researchers are evaluating the safety and recommended phase 2 dose regimens of pasritamig (JNJ-78278343) combined with other agents for treating metastatic prostate cancer. This phase 1b study focuses on men with metastatic castration-resistant or hormone-sensitive prostate cancer. The goal is to find optimal combination treatments and assess safety in patients who have received prior therapies for prostate cancer. The study involves administering pasritamig alongside several other drugs, including cetrelimab, cabazitaxel, docetaxel, apalutamide, enzalutamide, darolutamide, abiraterone acetate plus prednisone (AAP), lutetium Lu-177 vipivotide tetraxetan, and JNJ-101556143. Pasritamig and some agents are given orally, while others are delivered by intravenous infusion. The study has two parts: Part 1 is a dose escalation phase to identify recommended regimens, and Part 2 is a dose expansion phase to further evaluate safety at those doses. Participants will be monitored for safety, including dose limiting toxicities within 21 days after the first combination dose and adverse events up to nearly 3 years. Assessments include physical exams, laboratory tests, and evaluation of organ function. Researchers will also check prostate cancer progression and participants' overall health. The study requires men aged 18 and older with metastatic prostate cancer who meet specific prior treatment and health criteria. Close safety monitoring continues throughout the study to ensure participant well-being.

Researchers are evaluating overall survival in men with metastatic castration-resistant prostate cancer (mCRPC), a form of prostate cancer that has spread beyond the prostate and no longer responds to hormone therapies. This Phase 3 randomized trial compares pasritamig (JNJ-78278343), a T cell redirecting agent targeting human kallikrein 2, combined with best supportive care (BSC), against placebo with BSC to understand the length of time participants survive from the start of treatment. Participants receive pasritamig or placebo through intravenous infusion along with best supportive care, which is provided at the treating physician's discretion. The study focuses on men who have previously undergone multiple prostate cancer treatments including androgen-receptor pathway inhibitors, taxane chemotherapy, radioligand therapy, and possibly PARP inhibitors. Patients must continue ongoing hormone therapy during the treatment phase. During the study, participants are monitored for overall survival up to 2 years and 8 months. Assessments include clinical evaluations and laboratory tests to measure kidney and liver function, blood counts, and general health status. Safety and treatment effects are closely observed, with eligibility based on performance status and organ function. The trial aims to provide detailed long-term outcome data for this advanced prostate cancer treatment approach.

Researchers are evaluating whether combining pasritamig with docetaxel can extend the time before prostate cancer worsens, compared to docetaxel alone. This study focuses on participants with metastatic castration-resistant prostate cancer, a form of prostate cancer that continues to grow despite low male hormone levels. The trial is a Phase 3, randomized, open-label study assessing radiographic progression-free survival as the main outcome. Participants in this study receive pasritamig, a T-cell-redirecting agent targeting human kallikrein 2, along with docetaxel, a chemotherapy drug. Prednisone is also administered as part of the treatment. The study compares this combination therapy against docetaxel alone to determine if the addition of pasritamig can improve outcomes. During the study, participants undergo regular scans to monitor cancer progression and other assessments to evaluate their health status. Researchers track how long participants live without the cancer worsening based on imaging results. The study includes ongoing monitoring of treatment effects and safety, lasting up to nearly two years to observe radiographic progression-free survival.

Researchers are evaluating the effectiveness and safety of the drug BMS-986365 compared to the investigator's choice of therapy in men with metastatic castration-resistant prostate cancer. This Phase 3 study aims to measure the length of time participants live without radiographic disease progression, using established criteria for bone and soft tissue cancer progression. The study focuses on patients who have already been treated with androgen receptor pathway inhibitors and have metastatic prostate cancer confirmed by imaging. Participants will be randomly assigned to receive either one of two dose levels of BMS-986365 or the investigator's choice of treatment, which may include Docetaxel plus Prednisone/Prednisolone, Abiraterone plus Prednisone/Prednisolone, or Enzalutamide. The study has two parts: initially, participants are assigned to one of three groups including two BMS-986365 doses or comparator therapy, followed by a second part where they are randomized to either the selected BMS-986365 dose or the comparator treatment. During the study, participants will be monitored for disease progression through scans and evaluations using Response Evaluation Criteria in Solid Tumors and Prostate Cancer Clinical Trials Working Group criteria, with follow-up lasting up to four years. Safety and treatment effects will be assessed regularly, and participants' symptoms and quality of life will be closely observed. This long-term follow-up helps researchers understand the treatment's impact on cancer progression and patient well-being.