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Researchers are conducting an open-label, multi-site, multi-cohort phase 12 trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of ODM-212 combined with anti-cancer therapies in participants with advanced solid tumors, including mesothelioma, pancreatic cancer, and advanced non-small cell lung cancer NSCLC. The study aims to understand how ODM-212 works alongside other treatments in these serious cancers. The trial has two parts dose escalation and dose expansionoptimization. Participants receive ODM-212 tablets along with other anti-cancer drugs depending on their cancer type. For mesothelioma, ODM-212 is combined with ipilimumab and nivolumab given intravenously on specific schedules. For pancreatic cancer, it is combined with gemcitabine and nab-paclitaxel administered intravenously in cycles. For NSCLC with a KRAS G12C mutation, ODM-212 is combined with sotorasib taken orally daily in 21-day cycles. Participants will be closely monitored throughout the study, with evaluations of side effects, dose-limiting toxicities, and adverse events tracked on average for two years. The research team will collect tumor tissue samples, monitor treatment adherence, and perform assessments to measure disease status and treatment effects. Safety will be carefully checked with exams, ECGs, and laboratory tests. The study is planned to continue through 2029, with ongoing visits and follow-ups as part of participant involvement.

Researchers are evaluating calderasib alone or combined with cetuximab to treat people with advanced solid tumors that have the KRAS G12C mutation, excluding colorectal cancer. This study aims to measure how many participants experience tumor shrinkage or disappearance and compare the responses between the two treatments. It is a phase 2, open-label trial focused on treatment safety and tolerability. Participants will receive calderasib orally with no set limit on treatment cycles. Some participants will also receive cetuximab via intravenous infusion every two weeks. Treatment continues until criteria for stopping the study intervention are met. The trial uses a randomized, parallel design to compare the two experimental arms. Throughout the study, participants will be monitored for tumor response, adverse events, and treatment discontinuations related to side effects. Researchers will also assess progression-free survival, duration of response, and overall survival up to about 76 months. The trial lasts until April 2032, with ongoing safety and efficacy evaluations during this period.

Researchers are studying treatments for locally advanced or metastatic colorectal cancer mCRC that cannot be removed by surgery and has a specific KRAS G12C gene mutation. This trial aims to evaluate if adding the targeted therapies calderasib and cetuximab to the standard chemotherapy regimen mFOLFOX6 can provide better outcomes compared to mFOLFOX6 with or without bevacizumab. The study focuses on the safety and tolerability of these combinations and whether they can help people live longer without their cancer growing or spreading. Participants will be assigned to one of two groups. One group will receive calderasib orally, cetuximab every two weeks, and mFOLFOX6 chemotherapy including oxaliplatin, leucovorin or levofolinate calcium, and 5-fluorouracil every two weeks. The other group will receive mFOLFOX6 chemotherapy with or without bevacizumab every two weeks, based on the investigators decision. Treatments will continue until certain stopping criteria are met. During the study, participants will be monitored for side effects and treatment tolerance, with regular assessments of cancer progression. Researchers will measure outcomes such as dose-limiting toxicities, adverse events, progression-free survival, and overall survival. Quality of life will also be evaluated through questionnaires. The study may last up to several years, with monitoring continuing for safety and effectiveness throughout the treatment period and follow-up.

Researchers are investigating if intismeran autogene combined with pembrolizumab can prevent advanced melanoma from growing or spreading. Advanced melanoma is skin cancer that has spread to other parts of the body and cannot be removed with surgery. The study aims to see if people receiving intismeran autogene with pembrolizumab live longer without their cancer worsening than those receiving placebo with pembrolizumab. This is a phase 2 clinical trial evaluating these treatments in people with first-line advanced melanoma. Participants will receive either intismeran autogene or placebo via intramuscular injection every 3 weeks for up to 9 doses about 27 weeks. All participants will also receive pembrolizumab by intravenous infusion every 6 weeks for up to 17 doses, totaling around 2 years of treatment or until their disease progresses or they stop the treatment. The study compares the experimental combination to a placebo plus pembrolizumab to better understand the effects of intismeran autogene. During the study, participants will have regular assessments to measure how long they live without the cancer growing or spreading, as well as overall response and survival up to 6 years. Researchers will monitor side effects and reasons for stopping therapy for up to 2 years. Participants will undergo scans and tumor tissue analysis for biomarker studies. The trial includes a randomized design with triple masking and aims to enroll adults aged 18 and older with advanced melanoma.

Researchers are studying the safety and initial effects of T3011, given directly into tumors, alone and combined with the intravenous drug pembrolizumab. This Phase 12a open-label study focuses on adults with advanced or metastatic solid tumors, including melanoma, head and neck squamous cell carcinoma HNSCC, sarcoma, cutaneous squamous cell carcinoma cSCC, and non-small cell lung cancer NSCLC. The study aims to find safe dose levels and assess how well these treatments are tolerated and work in these cancer types. The study involves several groups Phase 1 tests increasing doses of T3011 alone to determine a recommended dose. Phase 2a Part 1 evaluates T3011 alone in participants with melanoma, HNSCC, sarcoma, and cSCC. Phase 2a Part 2 studies T3011 with pembrolizumab in NSCLC patients. A rollover arm allows participants whose cancer progresses on T3011 alone to receive the combination treatment. T3011 is given as an intratumoral injection every two weeks, and pembrolizumab is given intravenously every three weeks when combined. Participants will have tumor biopsies, imaging, and laboratory tests to monitor safety, drug levels, and cancer response. Researchers will track side effects and measure outcomes like tumor response and survival for up to two years after the first dose. Safety and tolerability are closely followed throughout, with additional monitoring for immune responses and drug presence in bodily fluids. Participants may be followed for up to one year after their last treatment dose to assess overall survival and long-term effects.

Researchers are evaluating the safety and tolerability of MK-4716, a drug being studied alone or combined with other treatments in people with certain advanced or metastatic solid tumors that have KRAS alterations. This phase 1, open-label study includes participants with locally advanced unresectable or metastatic solid tumors or metastatic non-small cell lung cancer, focusing on those with measurable disease and specific prior treatment histories. Participants receive MK-4716 at varying dose levels and schedules as monotherapy or combined with Pembrolizumab or Cetuximab. MK-4716 is given orally, while Pembrolizumab and Cetuximab are administered intravenously. The study uses a parallel design with several experimental arms to assess different combinations and dosing. During the study, participants are monitored for dose-limiting toxicities up to about 28 days and for adverse events up to approximately four years. Researchers measure drug concentrations in the blood at designated timepoints, pharmacokinetics, and overall safety. Participants undergo regular evaluations to assess side effects, treatment tolerability, and disease status throughout the study period, which lasts until study completion in December 2030.

Researchers are evaluating the combination of BNT324, a B7-H3 antibody-drug conjugate, with BNT327, a bispecific antibody targeting PD-L1 and VEGF, in participants with advanced, metastatic, or relapsed small cell lung cancer SCLC and non-small cell lung cancer NSCLC. This multi-part study aims to find safe doses, optimize treatment, assess preliminary effects, and confirm clinical efficacy in different lung cancer groups. The study includes participants with confirmed lung cancer who have measurable disease and meet specific health criteria. Participants will receive intravenous infusions of BNT324 combined with BNT327 in a dose escalation design to establish two recommended dose levels RP2D and RP2D-1. The study has two parts Part 1 focuses on dose finding in NSCLC and SCLC Part 2 compares these doses in treatment-naive and relapsed lung cancer cohorts, with some randomized groups. Additional participants may join at the optimal dose to further evaluate safety and effectiveness. Participants will undergo screening, followed by treatment, safety follow-up, and long-term survival monitoring. Researchers will assess dose-limiting toxicities, adverse events, treatment interruptions, and response rates using standardized criteria. Outcomes include objective response rate, disease control, progression-free survival, duration of response, and overall survival, with evaluations continuing up to 87 months. Safety is closely monitored during and after treatment, and participants health status is regularly assessed.

Researchers are evaluating LY3884961, a genetic therapy delivered as a single intravenous infusion, in adults with peripheral symptoms of Gaucher Disease. This Phase 12, open-label, multicenter study aims to assess the safety and tolerability of different dose levels of LY3884961. The study includes dose-finding cohorts followed by an expansion cohort to better understand the therapys effects in this patient group. Participants will receive one dose of LY3884961 and will be monitored closely for 18 months to evaluate safety, tolerability, immune response, biomarkers, and treatment effects. The study may include up to three dose levels tested in small groups of patients, with an additional group enrolled afterward. The total study duration for each patient is about five years, including a screening period of up to 60 days. During the trial, participants will have regular evaluations including laboratory tests, imaging, and clinical assessments to track treatment-emergent adverse events and changes in spleen volume, platelet count, and relevant biomarkers. Researchers will also monitor the use and discontinuation of enzyme replacement or substrate reduction therapies. Long-term safety and immune response will be followed for up to 42 months after the initial 18-month period.

Researchers are evaluating the efficacy and safety of trontinemab in people with early symptomatic Alzheimers disease, ranging from mild cognitive impairment to mild dementia due to Alzheimers. This Phase III trial aims to understand how trontinemab affects cognitive decline and disease progression in this population. Participants are randomly assigned to receive either intravenous trontinemab or a placebo in a parallel-group design. Treatment is administered by IV infusion, and the effects are compared over a period of 72 weeks. The study includes comprehensive safety and efficacy assessments throughout this period. During the 72 weeks of the study, participants will undergo various evaluations including cognitive tests such as the Clinical Dementia Rating-Sum of Boxes CDR-SB, Alzheimers Disease Assessment Scales, brain imaging with PET and MRI scans, and biomarker measurements in cerebrospinal fluid and blood. Safety monitoring includes tracking adverse events, infusion reactions, and antibody development. The study requires participants to have a study partner and to complete all study procedures over this time.

Researchers are evaluating the safety and dosing of COM503, given alone or with zimberelimab, in adults with advanced solid tumors. This first-in-human trial aims to find the maximum tolerated dose and recommended phase 2 dose of COM503 as both monotherapy and combined with zimberelimab. It focuses on advanced solid malignancies where standard treatments have failed or are unsuitable. The study includes several parts dose escalation of COM503 alone, dose escalation of COM503 combined with a fixed dose of zimberelimab, and dose expansion phases for both the monotherapy and combination therapy. Participants receive COM503 andor zimberelimab via intravenous infusion according to the assigned study part. During the trial, participants will undergo evaluations to monitor safety and tolerability from the first dose until 90 days after the last dose or the start of new anticancer therapy. Imaging with CT or MRI will assess tumor response. Researchers will track adverse effects, dosing limits, and overall safety profile over the study period. The trial is expected to last until November 2027.