Merriam

Researchers are evaluating GLB-001, an oral drug, in a first-in-human Phase 1 clinical trial for adults with relapsed or refractory acute myeloid leukemia RR AML or relapsed or refractory higher-risk myelodysplastic syndromes RR HR-MDS. The study aims to assess the safety, tolerability, how the drug moves and acts in the body, and initial effectiveness. The trial includes a dose escalation phase to find the highest safe dose and a dose expansion phase to confirm tolerability and explore clinical activity. The trial uses a standard dose-escalation design in Phase 1a to evaluate several dose levels of GLB-001, adjusting dose amounts or frequency based on safety and pharmacokinetic data. After determining the maximum tolerated or administered dose, Phase 1b will enroll participants at one or two selected dose levels to confirm tolerability and assess whether the drug shows enough activity to continue development. GLB-001 is given orally based on the assigned treatment schedule. Participants will be closely monitored for dose-limiting toxicities during the first 28 days, as well as adverse events over up to two years. Researchers will measure drug levels in the body, response rates such as remission, progression-free survival, and overall survival. Safety reviews will guide dose selection for future studies. The total study duration includes long-term follow-up to track outcomes and safety for up to two years after treatment begins.

Researchers are evaluating whether adding tucatinib to trastuzumab and mFOLFOX6 works better than the current standard treatments for people with HER2 positive metastatic colorectal cancer. This study focuses on participants whose cancer has spread or cannot be removed by surgery. The trial also monitors side effects that might occur from taking these drug combinations. Participants are randomly assigned to one of two groups. One group receives tucatinib taken orally twice daily along with trastuzumab given intravenously every three weeks and mFOLFOX6 chemotherapy every two weeks. The other group receives standard care, which includes mFOLFOX6 alone or combined with bevacizumab or cetuximab given by intravenous infusion. The study treatments continue as per the assigned schedule. During the study, participants undergo regular scans and evaluations to measure progression-free survival and other outcomes up to approximately three years. Researchers also assess overall survival, response rates, duration of response, quality of life, and side effects for up to about six years. Safety monitoring continues for around one year after the last treatment. Participants are closely followed to understand the impact of these treatments on their cancer and well-being.

Hepatocellular carcinoma HCC is a common and serious cancer often diagnosed at an advanced stage that cannot be surgically removed or has spread to other parts of the body. Researchers are evaluating the optimal dose, side effects, and effectiveness of the investigational drug livmoniplimab when combined with budigalimab for adults with advanced or metastatic HCC who have not received prior systemic treatment. This phase 23 randomized study aims to improve treatment options for this challenging condition. The study has two stages with different treatment groups. In Stage 1, participants are randomly assigned to one of three groups two groups receive different doses of livmoniplimab combined with budigalimab every three weeks, while the control group receives either atezolizumab with bevacizumab every three weeks or tremelimumab with durvalumab every four weeks. In Stage 2, participants are randomly assigned to receive either the optimized dose of livmoniplimab with budigalimab every three weeks or tremelimumab with durvalumab every four weeks. Treatment continues until the disease progresses or other discontinuation criteria are met. The study is expected to last about 56 months. Participants will have regular visits for treatments and monitoring at hospitals or clinics throughout the study. Assessments include medical exams, blood tests, questionnaires about quality of life, and scans to measure tumor response and disease progression. Researchers will evaluate outcomes such as overall survival, progression-free survival, response duration, and treatment safety. Participants may experience a higher treatment burden than standard care due to frequent visits and tests.

Researchers are evaluating the effectiveness, safety, and tolerability of adding ponsegromab to systemic chemotherapy for adults with metastatic pancreatic ductal adenocarcinoma mPDAC who also have cachexia, a condition marked by significant weight loss and fatigue. This Phase 2b3 randomized, double-blind study compares ponsegromab plus chemotherapy to chemotherapy plus placebo as first-line treatment. The study explores two doses of ponsegromab alongside common chemotherapy regimens nab-paclitaxel plus gemcitabine or FOLFIRINOX. Participants will be randomly assigned to receive one of two ponsegromab doses or placebo, each combined with their chemotherapy. The study intervention is administered subcutaneously every four weeks, starting on the same day as the chemotherapy cycle. After an initial Phase 2b period, researchers will select one ponsegromab dose for continued evaluation in Phase 3, where participants may continue or switch doses while remaining blinded. An optional open-label extension allows continued ponsegromab treatment for up to 12 months after the double-blind phase ends. There is also a sub-study to assess the impact of ponsegromab on the quality of life of caregivers. Participants will undergo tumor assessments every 6 to 8 weeks during the double-blind phase, with various evaluations measuring body weight changes, anorexia symptoms, physical activity, survival, muscle and fat composition, and side effects. Safety monitoring includes tracking adverse events, laboratory tests, and vital signs through Week 52. The study aims to gather data on the overall survival and physical function of participants, with involvement lasting until permanent discontinuation, withdrawal, death, or study completion.

Researchers are evaluating the study medicine called elranatamab in people with multiple myeloma MM that has returned or not responded to previous treatments, including prior anti-CD38 antibody and lenalidomide therapies. This Phase 3 trial aims to compare elranatamab with other commonly used combination therapies to understand its safety and how well it works for people with relapsed or refractory MM. Participants will be randomly assigned to receive either elranatamab alone or an investigators choice of combination therapies. Elranatamab is given as a weekly shot under the skin at the study clinic, which may become less frequent later. The combination therapies include various medicines taken by mouth and given as shots or intravenous infusions at the clinic. Treatment continues until the MM no longer responds. During the study, participants will visit the clinic regularly for monitoring and assessments, including evaluations of disease progression and response to treatment. Follow-up contacts by telephone or visits will continue after treatment ends. The main measure is progression-free survival, and other outcomes include overall survival, response rates, quality of life, and safety. The study may last up to about five years for some measures.

Researchers are evaluating the safety and effectiveness of elacestrant combined with other treatments in adults with advanced or metastatic estrogen receptor positive and HER2 negative breast cancer. This Phase 1b2 trial aims to find the best dose of elacestrant when given with drugs like alpelisib, everolimus, palbociclib, capivasertib, and ribociclib, then assess how well these combinations work and their safety. Participants receive elacestrant with one of several other cancer drugs in different groups. Doses vary by combination, with elacestrant given daily in 28-day cycles alongside drugs such as alpelisib, everolimus, ribociclib, palbociclib, capivasertib, or abemaciclib. Phase 1b focuses on dose finding with up to 125 participants, and Phase 2 evaluates treatment effects with around 310 participants across multiple arms. During the trial, participants are monitored for side effects and cancer progression. Measurements include dose-limiting toxicities in the first 28 days and progression-free survival at 6 months. Additional assessments cover drug levels, response rates, duration of response, clinical benefit, survival, and safety over several months. The study includes regular visits for evaluations and continues until the study ends or participants stop treatment.

Researchers are evaluating the effectiveness and safety of Adagrasib MRTX849 alone and combined with pembrolizumab in patients with advanced non-small cell lung cancer NSCLC who have the KRAS G12C mutation. The study includes a Phase 2 portion focusing on patients with various PD-L1 scores and a Phase 3 portion comparing Adagrasib plus pembrolizumab versus pembrolizumab alone in patients with high PD-L1 levels. This research aims to improve first-line treatment options for advanced NSCLC. The Phase 2 study has three groups two cohorts with low PD-L1 scores receiving either Adagrasib alone or combined with pembrolizumab, and one cohort with higher PD-L1 scores receiving the combination. In Phase 3, patients are randomly assigned to receive either Adagrasib with pembrolizumab or pembrolizumab alone. Adagrasib is taken orally twice daily, while pembrolizumab is given by intravenous infusion every three weeks. Participants will undergo regular assessments over 22 months for Phase 2 and 36 months for Phase 3, including evaluations of tumor response, safety, quality of life, and drug levels in the blood. Brain imaging is also used to check for metastases. Researchers will monitor progression-free survival, duration of response, and side effects to understand the treatments impact and tolerability throughout the study period.

Researchers are evaluating AMG 509 in participants with metastatic castration-resistant prostate cancer mCRPC to study its safety, tolerability, pharmacokinetics, and preliminary efficacy. The trial is a phase 1 interventional study sponsored by Amgen and includes participants who have previously been treated with novel hormonal therapies and taxane chemotherapy. Parts 4A expansion, 6, and 7 are currently open for enrollment as of mid-2025. The study includes multiple parts exploring different dosing methods and combinations. AMG 509 is given as an intravenous IV infusion in most parts and as a subcutaneous SC injection in one part. Some parts test AMG 509 alone, while others combine it with oral drugs abiraterone acetate or enzalutamide. Dose exploration phases aim to find the maximum tolerated dose or recommended phase 2 dose, with some parts enrolling participants from China to evaluate safety and dosing. The trial also includes outpatient infusion settings and focuses on participants with varying prior treatment histories. Participants undergo extensive monitoring including assessments of adverse events, vital signs, ECG, laboratory tests, and tumor response using RECIST criteria. The study measures pharmacokinetics such as serum concentration levels over time and evaluates prostate-specific antigen PSA responses and progression-free survival. The total duration for outcome monitoring can be up to three years for many measures. Participants organ functions and performance status are evaluated to ensure eligibility and safety throughout the trial.

Researchers are conducting a multicenter, randomized, open-label phase 3 trial to evaluate treatments for patients with metastatic non-small cell lung cancer NSCLC who have developed secondary resistance to immune checkpoint inhibitors ICI. The study focuses on patients positive for the HLA-A2 phenotype with either squamous or non-squamous histology. The trial compares the cancer vaccine OSE2101 to the standard chemotherapy drug docetaxel. Stratification factors include cancer histology and the patients performance status. Participants will be randomly assigned in a 21 ratio to receive either OSE2101 or docetaxel. OSE2101 is a peptidic cancer vaccine given by subcutaneous injection every three weeks for six cycles, then every eight weeks through the first year, and every twelve weeks during the second year. Docetaxel is given as an intravenous infusion every three weeks. Additionally, a companion diagnostic device system is used to detect HLA-A2 status and analyze genetic markers. During the study, patient survival will be monitored from the time of randomization for an average of three years. Researchers will track overall survival as the primary outcome. Patients will undergo regular treatment visits, assessments, and monitoring according to the schedule. Safety, efficacy, and disease progression will be evaluated throughout the trial period, which starts in December 2024 and continues until December 2028.