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Researchers are evaluating a new vaccine called V118C designed to prevent pneumococcal disease, which includes infections caused by the Streptococcus pneumoniae bacteria. This study focuses on toddlers and infants to understand the safety and tolerance of V118C. It is a Phase 1 trial that compares V118C to an existing pneumococcal vaccine called PCV20 in children. The study has two parts: Stage 1 involves toddlers aged 12 to 15 months who have already received three doses of PCV20 during infancy. Stage 2 involves infants around 2 months old who will receive four doses of V118C using a 3+1 schedule (three infant doses plus one toddler dose). Both vaccines are given by intramuscular injection. The study compares safety and immune response between V118C and PCV20. Participants will be monitored for immediate reactions within 30 minutes after vaccination and for local and systemic side effects up to 7 days post-vaccination. Unsolicited adverse events will be tracked up to 28 days, and serious or medically attended events will be assessed for up to 12 months after vaccination. The study aims to collect detailed safety and tolerability information over this period.

Researchers are investigating how bone mineral density changes during long-term treatment with the relugolix combination tablet in premenopausal women aged 18 to 50 who have heavy menstrual bleeding caused by uterine fibroids or moderate to severe pain related to endometriosis. This Phase 3B, single-arm, open-label study aims to assess the safety and effects of up to 48 months (4 years) of continuous treatment, followed by a 1-year post-treatment follow-up period. Participants will receive a daily fixed-dose tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg. Bone mineral density will be monitored every 6 months using dual-energy X-ray absorptiometry during treatment. Some women who completed a prior related study may join for 3 years of treatment under this protocol. After treatment ends or if stopped early, participants will be followed for 1 year with bone density checks at 6 and 12 months. Women in the study will have regular physical, gynecological, and laboratory assessments to monitor health and treatment effects. Researchers will measure the percentage change from baseline in bone mineral density at the lumbar spine after 48 months of treatment. Safety and health status will be closely observed throughout the treatment and follow-up periods to understand the long-term impact of the relugolix combination tablet on bone health.

Researchers are evaluating the safety and effectiveness of Raludotatug Deruxtecan (R-DXd) in people with platinum-resistant, high-grade ovarian, primary peritoneal, or fallopian tube cancer. This study includes two parts: Phase 2 to find the best dose based on safety and response, and Phase 3 to compare R-DXd with the investigator's choice of chemotherapy. R-DXd is an antibody-drug conjugate that targets CDH6, a protein overexpressed in tumor cells. Participants will receive R-DXd through intravenous infusions. In Phase 2 (Part A), the dose will be optimized, and biopsies will be collected before and during treatment if possible. In Phase 3 (Part B), participants will be randomly assigned to receive either R-DXd or chemotherapy chosen by their doctor, which may include paclitaxel, topotecan, or PLD, all given by IV infusion. The study monitors treatment effects up to 18 months in Phase 2 and up to 26 months in Phase 3. During the study, participants will have regular scans and assessments to measure tumor response and progression-free survival. Researchers will monitor safety and organ function through lab tests and performance status evaluations. Participants must be willing to follow the study visits and procedures, which include biopsy samples in Phase 2 and imaging assessments to evaluate treatment response. The study aims to provide detailed information about how well R-DXd works and its safety in this patient group.

Researchers are evaluating the safety and effects of the medicine PF-07248144 combined with fulvestrant for treating hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. This type of breast cancer involves cancer cells that grow in response to hormones like estrogen and progesterone but have little or no HER2 protein. The study focuses on people whose breast cancer worsened after treatment with cyclin dependent kinase (CDK) 4/6 inhibitor therapy. The trial is a phase 3, open-label, randomized study comparing PF-07248144 plus fulvestrant to other therapies chosen by doctors. Participants will receive either PF-07248144 tablets daily at home in 28-day cycles combined with fulvestrant injections at the clinic, or the usual treatment of everolimus tablets with endocrine therapy (either exemestane or fulvestrant). The study doctor will help decide the hormone therapy before starting treatment. The trial compares the experiences of those taking PF-07248144 plus fulvestrant with those receiving standard treatments to assess safety and effectiveness. During the study, researchers will monitor participants for disease progression or death, using blinded independent central review based on standard tumor response criteria. The main outcome measure is progression-free survival for up to about 2 years from randomization. Regular assessments, including clinical visits for injections and evaluations, will help track treatment effects and safety throughout the study.

Researchers are evaluating the safety, tolerability, and effects of a study medicine called PF-08032562 in people with advanced or metastatic breast or colorectal cancer. This Phase 1 study aims to find the best dose of PF-08032562, given alone or with other anti-cancer treatments. Participants have advanced solid tumors, including several types of breast cancer and colorectal cancer. Participants will take PF-08032562 by mouth in 28-day cycles. Depending on the study part, they may receive PF-08032562 alone or combined with other anti-cancer drugs such as Fulvestrant, Cetuximab, Fluorouracil, Oxaliplatin, Leucovorin, or Bevacizumab. These additional treatments are given in the clinic by muscle injection or intravenous infusion at different times during the cycle. The study may also explore different dosing schedules. During the study, researchers will monitor participants for dose-limiting toxicities, side effects, and laboratory abnormalities from the start of treatment to up to 30 days after the last dose or new therapy. In the expansion phase, they will assess how well the cancer responds over about two years with regular evaluations every 8 to 12 weeks. Participants will undergo exams, scans, lab tests, and safety monitoring throughout their involvement.

Researchers are evaluating the study medicine PF-08046054 compared to the standard chemotherapy drug docetaxel in adults with non-small cell lung cancer (NSCLC) that has spread or cannot be removed with surgery or radiation. Participants must have PD-L1 expression on 1% or more of their tumor cells and have experienced cancer progression during or after treatment with PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted therapies for those with known genetic mutations. The trial is a Phase 3 randomized study to better understand how well PF-08046054 works alone compared to docetaxel alone. Participants will be randomly assigned to receive either PF-08046054 or docetaxel. Those in the PF-08046054 group will get intravenous (IV) infusions twice every 21-day cycle, while those in the docetaxel group will receive one IV infusion every 21 days. The treatment period may last up to 5 years if their NSCLC responds to the therapy. No other treatments are combined during the study period. Throughout the study, participants will have regular clinic visits for evaluations and monitoring to see how they respond to the treatment. Researchers will collect information on overall survival over approximately 5 years. They will also monitor safety and disease progression during these visits to understand the long-term effects and benefits of the treatments.

Researchers are investigating the safety and effects of an investigational anticancer drug called PF-08046876 in adults diagnosed with advanced cancers of the bladder, lung, head and neck, esophagus, or pancreas. This drug is an antibody drug conjugate (ADC), designed to specifically target and kill cancer cells. The study focuses on patients with advanced or metastatic solid tumors, exploring how this new therapy performs in these conditions. The study drug, PF-08046876, is administered through a needle into a vein (intravenous infusion). The trial is divided into multiple parts, with different groups receiving varying doses and possibly different dosing schedules of the study drug. The first part explores dose levels and schedules, while later parts aim to identify recommended doses for further investigation. Participants will be monitored for safety, including treatment emergent adverse events and dose-limiting toxicities, from the start of treatment through 30 days after the last dose or new anticancer therapy. Other assessments include evaluating recommended doses for expansion and phase 2 dosing. The study requires submission of tumor tissue samples before treatment and observes participants closely for any side effects or toxicities during and after treatment.

Researchers are studying the effects and safety of felzartamab, a laboratory-made monoclonal antibody, in adults with primary membranous nephropathy (PMN), a condition where harmful autoantibodies build up in the kidney filters causing damage. This damage leads to protein leaking into the urine, swelling, tiredness, and high blood pressure, which can progress to kidney failure if untreated. The study aims to compare felzartamab to tacrolimus, a standard oral medication, to see how well each helps achieve complete remission of proteinuria and maintains kidney function over 104 weeks. Participants will be randomly assigned to receive either felzartamab through intravenous infusions or tacrolimus tablets by mouth. The study includes a screening period of up to 42 days before treatment begins. If a participant's kidney function worsens, proteinuria increases, or the disease relapses without improvement, rescue treatment options are available. Those stopping treatment early will have follow-up visits every 12 weeks until week 104. Participants without rescue treatment will continue in the study for up to 104 weeks, while those needing rescue treatment may stay for up to 156 weeks, with a total of up to 23 study visits. Throughout the study, researchers will monitor how many participants achieve complete remission, how long remission lasts, and the development of antibodies against felzartamab. They will also assess the drug's safety, how it is processed in the body, and its effects on participants' tiredness and overall physical health. Regular evaluations, including laboratory tests and patient-reported outcomes, will help understand the treatment impact and safety over the long term.

Researchers are investigating the addition of an immunotherapy drug called durvalumab to standard chemotherapy treatment in patients with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial aims to compare the effectiveness of usual chemotherapy alone versus chemotherapy combined with durvalumab. Immunotherapy with durvalumab may help the immune system attack cancer cells and prevent tumor growth and spread, while chemotherapy drugs like paclitaxel, doxorubicin, and cyclophosphamide work to stop cancer cells from growing or dividing. Previous studies suggest patients with an MP2 result might respond better to this combined treatment approach. Participants first undergo MammaPrint testing to confirm MP2 status before randomization into two groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for 6 cycles, followed by doxorubicin and cyclophosphamide intravenously on day 1 every 14 days for 4 cycles. The other group receives the same chemotherapy schedule plus durvalumab intravenously over 60 minutes on specified cycles during both chemotherapy phases. Mammography is performed during screening, and optional tissue and blood samples are collected for future studies. Throughout the study, participants are monitored through various assessments including imaging, physical exams, laboratory tests, and quality of life questionnaires focusing on fatigue and physical and mental health. Researchers track breast cancer event-free survival and other outcomes such as treatment side effects and response rates. After completing treatment, patients are followed for up to 10 years or until death to evaluate long-term outcomes and safety.

Researchers are evaluating the safety and immune response of a group B streptococcus (GBS) vaccine in healthy pregnant women and their babies in this Phase 3 randomized, placebo-controlled, double-blinded trial. The study includes pregnant women aged 49 or younger between 24 and 36 weeks of gestation with uncomplicated singleton pregnancies and no major fetal abnormalities. Participants must also have documented negative tests for HIV, syphilis, and hepatitis B during this pregnancy. The goal is to learn how the vaccine works and to monitor safety for both mothers and their infants. Participants will receive one injection of either the GBS6 vaccine or a saline placebo. Pregnant women will be followed for up to 14 months, including 6 months after delivery. Their babies will be followed for about 12 months after birth. A subset of infants will also receive routine vaccinations such as diphtheria toxoid-containing vaccines and pneumococcal vaccines according to their country's immunization schedule, with blood samples collected one month after completing primary and toddler booster doses. Mothers will be monitored for local and systemic reactions within 7 days after vaccination, adverse events through 1 month, and serious or medically attended events up to 6 months postpartum. Infants will be observed for adverse events from birth through at least one year, with serious and medically attended events tracked through 6 months. Researchers will also measure antibody levels in infants at birth to assess the vaccine's potential to protect against early and late onset GBS disease. Mothers will attend at least 3 to 4 study visits, some via telephone, to support ongoing safety and immunogenicity assessments.