Kurralta Park

Researchers are evaluating the safety and effectiveness of VS-7375, an oral KRAS G12D inhibitor, alone and in combination with cetuximab or panitumumab, and cetuximab plus mFOLFOX chemotherapy in patients with metastatic KRAS G12D-mutated colorectal cancer. This phase 2 study focuses on patients with advanced colorectal cancer who have specific genetic mutations and aims to explore treatments for different lines of therapy. Participants will be randomly assigned in a 21 ratio to receive either VS-7375 alone or combined with cetuximab or panitumumab, or VS-7375 combined with cetuximab and mFOLFOX chemotherapy. Treatments include oral administration of VS-7375 daily and intravenous infusions of cetuximab, panitumumab, and mFOLFOX. The study includes groups for patients receiving second-line or later therapy and treatment-nave patients or those with limited prior treatment. During the study, participants will undergo evaluations including imaging to measure tumor response, pharmacokinetic and pharmacodynamic blood tests, and quality of life questionnaires. Safety and tolerability of treatments will be closely monitored over six months, with longer-term assessments up to two years for some outcomes. The primary measure is confirmed objective response rate by independent review using RECIST criteria. The total participation duration varies, with ongoing follow-up to assess treatment impact and safety.

Researchers are evaluating the safety and effectiveness of the oral drug VS-7375 alone and combined with the drug cetuximab in patients who have metastatic pancreatic cancer with a specific KRAS G12D mutation. This Phase 2 clinical trial focuses on understanding how well these treatments work and their safety profiles in this particular group of patients. Participants may receive VS-7375 by mouth either alone or with cetuximab given as a subcutaneous infusion. The study includes different groups where participants receive either VS-7375 alone, VS-7375 plus cetuximab as a second-line treatment, or VS-7375 plus cetuximab as a first-line treatment. The trial involves random assignment to these groups and includes a crossover design. During the study, participants will be monitored for their tumor response using imaging reviewed by an independent central team according to RECIST criteria. Safety and tolerability of the treatments will also be assessed over six months. Additional evaluations include measuring drug levels in the blood, tumor markers, quality of life through questionnaires, and timing until the next therapy. The trial is expected to continue until December 2028.

Researchers are evaluating the safety and effectiveness of three different dose regimens of MORF-057, a small molecule drug, in adults with moderately to severely active Crohns disease CD. This Phase 2, randomized, double-blind, placebo-controlled, multicenter study aims to compare these doses with a matching placebo during an induction treatment period. The study includes adult participants who have active symptoms of CD and have not adequately responded to other treatments. Participants will first undergo a 14-week induction period where they receive either one of the three blinded MORF-057 dose regimens or a matching placebo, all taken orally. Following this, all participants enter a 38-week maintenance period receiving open-label MORF-057. Those who complete this 52-week treatment phase may have the chance to continue treatment for an additional 52 weeks during a long-term extension. MORF-057 is designed to selectively inhibit integrin 47. During the study, participants will have their disease activity monitored using endoscopic assessments and clinical symptom scores, such as the Simple Endoscopic Score for Crohns Disease SES-CD and the Crohns Disease Activity Index CDAI. Researchers will assess the proportion of participants showing endoscopic response and clinical remission at Week 14. Safety and adherence will be closely followed throughout the treatment and extension phases. The entire study spans up to 6 years, allowing for long-term evaluation.

Researchers are evaluating the drug FMC-376 in adults with advanced solid tumors that have a specific KRAS G12C mutation. This clinical trial is designed in three parts Phase 1A dose escalation, Phase 1B dose expansion, and Phase 2 cohort expansion, to study various dose levels in participants with these tumors. The trial focuses on tumors that are locally advanced, unresectable, or metastatic, including types like non-small cell lung cancer, colorectal cancer, and pancreatic cancer. Participants will receive FMC-376 orally as a daily capsule in 21-day cycles during the dose escalation, dose expansion, and cohort expansion phases. The study does not include placebo or blinded treatments. The trial aims to assess the safety, pharmacokinetics how the drug is absorbed and processed, and clinical activity of FMC-376 at multiple dose levels. During the study, participants will be monitored closely for dose-limiting toxicities within the first 21 days and adverse events for approximately 24 months. Researchers will measure drug levels in the blood, response rates, duration of response, disease control, progression-free survival, and overall survival. Participants will undergo regular assessments including laboratory tests and evaluations to track safety and treatment effects throughout the study period.

Researchers are studying pirtobrutinib, an oral drug, to understand how well it works and how safe it is for people with chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL. The study focuses on participants who have previously received 1 to 3 treatments, including a covalent Bruton tyrosine kinase BTK inhibitor, as well as those with treatment-nafve CLLSLL who have a specific genetic change called 17p deletion. This is a Phase 2 open-label trial sponsored by Loxo Oncology, Inc. The study has two parts. Part 1 tests three different dose levels of pirtobrutinib in participants with relapsed or refractory CLLSLL who have prior treatment experience, lasting about 3 years. Part 2 evaluates pirtobrutinib alone in participants who have not received prior treatment but have the 17p deletion, with participation lasting up to 2 years. All doses are given orally. Participants will take the study drug orally and attend visits for up to 3 years in Part 1 or up to 2 years in Part 2. Researchers will monitor how well the disease responds to treatment using overall response rate and how long the response lasts. Safety will be tracked throughout. Participants ability to swallow oral medication and their overall health status will be assessed before and during the study to ensure suitability and safety.

Researchers are evaluating BGB-26808, alone or combined with tislelizumab, in people with advanced solid tumors that are metastatic or cannot be removed by surgery. This open-label, multicenter, nonrandomized Phase 1 study aims to find the recommended doses of BGB-26808 and assess its safety, tolerability, and early antitumor activity. The study is sponsored by BeOne Medicines, previously known as BeiGene. Participants will receive increasing doses of BGB-26808 either by itself or combined with tislelizumab and chemotherapy, depending on the study phase. BGB-26808 is given daily as an oral tablet, while tislelizumab is administered by intravenous infusion. The study includes a dose escalation phase Phase 1a and a dose expansion phase Phase 1b to evaluate appropriate dosing and response. During the study, participants will be monitored for adverse events and serious adverse events from the first dose until 90 days after the last dose or start of new treatment, for up to about 12 months. Researchers will also measure tumor response rates, duration of response, disease control, clinical benefit, and pharmacokinetic properties like drug concentration in the blood. Study visits will include tumor assessments, blood tests, and safety evaluations over several months.

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 evaluating how well JNJ-78934804 works and how safe it is compared to guselkumab in participants with moderately to severely active Crohns disease, a long-term and progressive condition affecting the intestine. This Phase 3 trial aims to assess clinical remission and endoscopic remission at Week 48, focusing on treatment efficacy and safety. Participants are randomly assigned to receive either JNJ-78934804 or guselkumab. Both treatments involve induction doses at Weeks 0, 4, and 8, followed by maintenance doses every 4 weeks starting at Week 12. Participants meeting rescue criteria will receive additional induction doses of JNJ-78934804 at Weeks 16, 20, and 24, with maintenance doses continuing every 4 weeks from Week 28. Those completing the double-blind phase at Week 48 may enter a long-term extension phase if the investigator believes they may benefit. During the study, participants will be monitored for clinical and endoscopic remission, deep remission, corticosteroid-free remission, and patient-reported outcomes up to Week 48. Researchers will also track adverse events for up to approximately three years. Assessments include symptom scores, endoscopy reviews, and quality-of-life questionnaires to evaluate the treatments effects and safety throughout the trial.

Researchers are evaluating the effectiveness and safety of JNJ-78934804 compared to guselkumab in people with moderately to severely active ulcerative colitis UC, a chronic condition where the colon lining becomes inflamed and develops ulcers. This Phase 3 study aims to measure clinical remission and other health improvements by Week 48. Participants receive an induction dose of either JNJ-78934804 or guselkumab at Weeks 0, 4, and 8, followed by maintenance doses every 4 weeks starting Week 12. Those meeting rescue criteria will receive additional induction doses of JNJ-78934804 at Weeks 16, 20, and 24, then maintenance doses every 4 weeks from Week 28. After completing the 48-week double-blind treatment phase, participants benefiting from the intervention may join a long-term extension phase. Throughout the study, participants will be monitored for clinical remission, endoscopic improvement, corticosteroid-free remission, fatigue, abdominal pain, quality of life, and mental health responses. Safety is assessed by tracking adverse events up to about 3 years. The study involves randomized assignment and double-blinding, with all treatments given by subcutaneous injection. Participation may last up to several years including follow-up and extension phases.

Researchers are studying MGC026, a drug designed to target advanced solid tumors that are relapsed, refractory, unresectable, locally advanced, or metastatic. This Phase 11b study aims to evaluate the safety, tolerability, how the body processes the drug, immune response, and preliminary antitumor effects. The study includes a dose escalation phase followed by a cohort expansion phase to better understand MGC026s effects in different groups of patients. Participants will receive MGC026 through intravenous infusion every three weeks. The dose will be assigned at enrollment. They may continue treatment for up to 35 cycles as long as there are no severe side effects and the cancer does not worsen. The drug is a topoisomerase 1 inhibitor-based antibody-drug conjugate targeting B7-H3. The study monitors participants for side effects, cancer progression, and collects blood samples for routine lab testing and research. During the study, participants will have regular monitoring for adverse events and cancer status over a period of up to 135 weeks. Blood samples will be taken at scheduled times for pharmacokinetic and immunogenicity analyses. Researchers will assess the number and severity of side effects, response rates, duration of response, and development of antibodies against MGC026. Participants health and safety will be closely observed throughout the trial period.