Merriam

Researchers are conducting a first-in-human, Phase 1 clinical trial to study GLB-001 in adults with relapsed or refractory acute myeloid leukemia (R/R AML) or relapsed or refractory higher-risk myelodysplastic syndromes (R/R HR-MDS). The study aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary effectiveness of this oral drug. The trial includes a dose escalation phase to find the maximum tolerated or administered dose and a dose expansion phase to explore dose-response relationships and select doses for future studies. The study uses a standard 3+3 dose-escalation design in Phase 1a to test several dose levels of GLB-001 taken by mouth. After determining the maximum tolerated or administered dose, one or two dose levels will be expanded in Phase 1b, with about 12 participants enrolled per dose level based on safety recommendations. The recommended Phase 2 dose will be selected using data from pharmacokinetics, pharmacodynamics, safety, and efficacy gathered during both phases. Participants will be closely monitored for dose-limiting toxicity up to 28 days after their first dose in Phase 1a and for adverse events up to two years. The study will also assess maximum tolerated dose, maximum administered dose, and recommended Phase 2 dose over this period. Assessments include safety evaluations, laboratory tests, and clinical activity monitoring throughout the treatment and follow-up period, with an expected participation duration of up to two years.

Researchers are evaluating whether tucatinib combined with trastuzumab and mFOLFOX6 works better than the standard treatments for people with HER2 positive metastatic colorectal cancer, which is cancer that has spread or cannot be removed by surgery. This phase 3 study also aims to identify the side effects that may occur with this drug combination. Participants must have HER2 positive disease confirmed by testing and measurable cancer according to specific criteria. Participants will be randomly assigned to one of two groups. One group will receive tucatinib taken orally twice daily along with intravenous trastuzumab and the mFOLFOX6 chemotherapy regimen, which includes oxaliplatin, leucovorin or levoleucovorin, and fluorouracil given by IV every two weeks. The other group will receive standard care, which could be mFOLFOX6 alone or combined with either bevacizumab or cetuximab, both given by IV on specific schedules. Treatment continues as per the study protocol. During the study, participants will be monitored for progression-free survival up to about three years using imaging reviewed by independent experts. Researchers will assess side effects and disease response. Participants must be able to provide tumor tissue samples for testing and have a good performance status. The study includes brain imaging to check for metastases and monitors safety closely throughout the treatment period.

Hepatocellular carcinoma (HCC) is a common and serious type of liver cancer that often presents as advanced or metastatic disease that cannot be removed by surgery. This research aims to assess the best dose, safety, and effectiveness of the investigational drug livmoniplimab combined with budigalimab in adults with advanced HCC who have not yet received systemic treatment. The study is a Phase 2/3 trial involving about 660 participants worldwide, comparing different drug combinations over up to 56 months. The study has two stages with different treatment groups. In Stage 1, participants are randomly assigned to one of three groups receiving either livmoniplimab at two different doses plus budigalimab every 3 weeks, or one of two control treatments: atezolizumab with bevacizumab every 3 weeks, or tremelimumab with durvalumab every 4 weeks. In Stage 2, participants are randomized to receive either the optimized dose of livmoniplimab plus budigalimab every 3 weeks or the tremelimumab and durvalumab combination every 4 weeks. Treatment continues until the disease worsens or other stopping criteria are met. Participants will have regular visits at hospitals or clinics for ongoing treatment and monitoring, including medical exams, blood tests, questionnaires, and scans. Researchers will measure the best overall response to treatment and overall survival throughout the study. The study may require more frequent visits and assessments than usual care. The total study duration is estimated to be about 56 months.

Researchers are evaluating a medicine called elranatamab for the treatment of multiple myeloma (MM), a type of cancer. This study focuses on people aged 18 or older who have MM that has returned or not responded to previous treatments, including prior use of an anti-CD38 antibody and lenalidomide. The goal is to compare elranatamab to other common combination therapies that include 2 to 3 different MM medicines. This is a Phase 3 study to learn about the safety and effectiveness of elranatamab compared to these other treatments. Participants will be randomly assigned to receive either elranatamab or a combination therapy selected by the study doctor. Elranatamab is given as a shot under the skin at the study clinic about once a week, which may later reduce in frequency. The combination therapy options include medicines taken by mouth and given either as shots under the skin or through a needle in the vein at the clinic. The combination medicines used may be elotuzumab, pomalidomide, dexamethasone, bortezomib, or carfilzomib, depending on the chosen treatment plan. Participants may continue their assigned treatment until their MM stops responding. During the study, participants will visit the clinic regularly for monitoring and evaluation. Researchers will track how well the treatments work by measuring progression-free survival and will watch for any side effects or safety concerns. Follow-up will continue after treatment ends through phone calls or visits. The study may last up to about 5 years to fully assess the outcomes of the treatments.

Researchers are evaluating the safety and effectiveness of elacestrant combined with other drugs in adults with advanced or metastatic estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) breast cancer. This multicenter Phase 1b/2 trial aims to find the recommended dose of elacestrant in combination with alpelisib, everolimus, palbociclib, capivasertib, and ribociclib in Phase 1b, and then assess the safety and efficacy of these combinations in Phase 2. During Phase 1b, participants receive elacestrant at various doses along with one of the other drugs, such as alpelisib, everolimus, ribociclib, palbociclib, capivasertib, or abemaciclib, in treatment cycles of 28 days. Phase 2 includes multiple treatment arms with fixed participant numbers per combination, evaluating these drug combinations over similar 28-day cycles. Each drug has specific dosing schedules, such as once daily or twice daily, with some requiring days off during the cycle. Participants will undergo assessments including monitoring for dose-limiting toxicities during the first 28-day cycle and progression-free survival over six months. The study involves regular evaluations of disease status and safety, including physical exams and laboratory tests. Overall, Phase 1b will have up to 125 participants, while Phase 2 will include about 310 participants across all treatment groups.

Researchers are studying the effects of Adagrasib alone and combined with pembrolizumab in adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have the KRAS G12C mutation. The Phase 2 part evaluates these treatments in patients who are candidates for first-line therapy, with different groups based on their PD-L1 tumor proportion scores (TPS). The Phase 3 part compares the combination of Adagrasib and pembrolizumab against pembrolizumab alone in patients with NSCLC having PD-L1 TPS of 50% or higher. In Phase 2, there are three patient groups: two with PD-L1 TPS less than 1% randomized to receive either Adagrasib monotherapy or Adagrasib plus pembrolizumab, and one group with PD-L1 TPS of 1% or higher treated with the combination. Adagrasib is given orally at doses of 400 mg twice daily or 600 mg twice daily depending on the group, while pembrolizumab is administered intravenously at 200 mg every three weeks. Phase 3 patients are randomized to receive either Adagrasib 400 mg twice daily plus pembrolizumab 200 mg every three weeks or pembrolizumab alone. Participants will undergo various assessments including brain imaging, tumor measurements, and evaluations of safety and treatment effects over 22 months in Phase 2 and 36 months in Phase 3. Researchers will monitor efficacy, safety, and drug levels, as well as patient-reported outcomes and genetic biomarkers. The study includes patients with untreated or previously treated brain metastases under specific conditions and excludes those with prior systemic treatments for advanced NSCLC or certain brain lesion characteristics.

Researchers are evaluating AMG 509, a drug given alone or combined with abiraterone acetate and enzalutamide, in men with metastatic castration-resistant prostate cancer (mCRPC) to assess its safety, tolerability, how the body processes it, and early signs of effectiveness. This Phase 1 study focuses on specific parts of the trial open to enrollment as of July 2025, aiming to understand how AMG 509 works in this advanced prostate cancer setting. Participants receive AMG 509 either as an intravenous infusion or a subcutaneous injection, depending on the study part. Some receive it alone, while others take it alongside oral tablets of abiraterone or enzalutamide. The study includes dose exploration and expansion phases across multiple parts, with specific criteria for prior treatments and combinations allowed. Treatment schedules and dosages vary by study part and participant group. During the study, participants undergo regular monitoring for side effects, vital signs, heart function via ECG, and lab tests for up to three years. The study measures treatment-emergent and treatment-related adverse events, dose-limiting toxicities, and objective tumor responses according to standard criteria. Safety and tolerability are closely observed, with follow-up assessments to capture long-term effects and overall participant health throughout the trial.

Researchers are conducting a phase 3, multicenter, randomized, open-label study to compare treatments in patients with metastatic non-small cell lung cancer (NSCLC) who have developed secondary resistance to immune checkpoint inhibitor (ICI) therapy. The study focuses on patients positive for the HLA-A2 phenotype and includes both squamous and non-squamous types of NSCLC. Participants will be grouped based on cancer histology and their performance status to better understand treatment effects. Participants will be randomly assigned in a 2:1 ratio to receive either the experimental treatment OSE2101 or the standard treatment docetaxel. OSE2101 is a cancer vaccine made of nine specific peptide components targeting tumor-associated antigens, combined with an adjuvant to enhance immune response. Docetaxel, the control treatment, is a chemotherapy drug that disrupts cell division. The study uses an assay device to confirm HLA-A2 status before treatment allocation. During the average three-year study period, researchers will monitor overall survival, defined as the time from randomization until death. Patients will be regularly assessed for treatment response and safety. The trial aims to gather important data on the efficacy and tolerability of the OSE2101 vaccine compared to docetaxel in this patient population with metastatic NSCLC and secondary resistance to ICI therapy.