Babylon

Researchers are evaluating a drug called sigvotatug vedotin SGN-B6A alone and in combination with pembrolizumab, with or without chemotherapy, to assess its safety and effects in people with advanced solid tumors. This Phase 1 study aims to determine the side effects and whether sigvotatug vedotin works to treat various solid tumors including lung, head and neck, breast, esophageal, skin, pancreatic, bladder, cervical, gastric, and ovarian cancers. The study is divided into four parts to explore dosage, safety, and combination treatments. Participants may receive sigvotatug vedotin alone or combined with pembrolizumab, sometimes alongside chemotherapy drugs carboplatin or cisplatin, depending on the study part. Part A focuses on finding the right dose of sigvotatug vedotin. Part B uses this dose to further test safety and effectiveness. Parts C and D study the drug combined with pembrolizumab and possibly chemotherapy in different tumor types and treatment settings, including people who have not previously received treatment. Treatments are given intravenously, with pembrolizumab administered every 3 or 6 weeks and chemotherapy every 3 weeks. During the study, participants undergo tumor biopsies, clinical evaluations, and monitoring for side effects, including blood tests and safety assessments. Researchers track adverse events, lab abnormalities, and dose-limiting toxicities up to 30-37 days after treatment, with some follow-up extending up to 3 years. They also measure tumor response using standard criteria and monitor survival and drug levels in the body. Participants will have regular visits for treatment and assessments throughout the study duration, which may last several years.

Researchers are evaluating the effectiveness and safety of fusidic acid 1% eye drops compared to a placebo for treating bacterial conjunctivitis in both adults and children. This Phase 3 clinical trial aims to show that fusidic acid 1% is superior to placebo in curing bacterial conjunctivitis and to further confirm its safety when applied topically to the eyes. Participants will be randomly assigned to one of two groups one group will apply one drop of fusidic acid 1% in each eye twice daily for seven days, and the other group will use a placebo eye drop with the same schedule. The doses are ideally spaced about 12 hours apart, but the twice-daily application schedule is prioritized over exact timing. During the study, participants will be assessed for clinical cure and microbial eradication at Day 4 and Day 8 visits. Researchers will monitor safety and treatment effects through these evaluations and by tracking any adverse events. The total participation duration covers at least the seven days of treatment plus follow-up assessments, helping establish both effectiveness and safety profiles for the treatment.

Researchers are reviewing anonymous medical records from multiple centers to understand the outcomes of different treatments for chronic pain. This study includes several groups to assess how various approaches work in distinct patient subgroups. The focus is on patients who have had or may have spinal cord stimulation systems or other treatments like radiofrequency RF or intradiscal therapies IDS. The study looks at patients who have previously received spinal cord stimulation or other therapies and those who have switched to different treatments afterward. Treatments under review include Boston Scientific devices and non-Boston Scientific systems such as spinal cord stimulation, RF, and IDS. The data is retrospective, meaning it examines past patient experiences without introducing new treatments. Participants involvement consists of the analysis of their de-identified medical charts, with no active treatment or visits required. Researchers will measure responder rates approximately two years from the start of data collection to evaluate treatment outcomes. The study spans from April 2012 to December 2030, focusing on long-term clinical results in chronic pain management.

Researchers are evaluating the use of circulating tumor DNA ctDNA testing to guide the timing of CDK46 inhibitor therapy in people with intermediate-risk, early-stage hormone receptor-positive HR, HER2-negative breast cancer. The study aims to determine if starting CDK46 inhibitor therapy based on ctDNA test results can maintain treatment effectiveness while reducing unnecessary therapy. Participants will be followed for up to nine years to monitor outcomes and quality of life. Participants will have ctDNA testing every three months using the Signatera Genome assay customized for each persons tumor. Those with positive ctDNA results will begin CDK46 inhibitor therapy ribociclib or abemaciclib along with hormone therapy. Participants with negative ctDNA results will continue hormone therapy alone and undergo ongoing ctDNA monitoring. If ctDNA positivity appears during follow-up, further staging will be done before starting CDK46 inhibitors. Treatment continues until disease progression, unacceptable side effects, or study completion. During the study, participants will have regular blood draws for ctDNA testing, hormone therapy, and imaging as needed. Researchers will track invasive disease-free survival for up to nine years after surgery. Outcomes at four years will be compared to a previous trial to assess if ctDNA-guided treatment timing is effective. Participants will also complete quality-of-life assessments and be monitored for safety throughout the study.

Researchers are evaluating overall survival in patients with advanced metastatic or locally recurrent breast cancer who have no approved alternative therapies available. This Phase 3, multicenter, randomized, open-label study compares a new combination treatment called the Bria-IMT regimen plus a checkpoint inhibitor Retifanlimab against treatment chosen by patients and their physicians. The study also aims to assess the effectiveness of the Bria-IMT regimen alone compared to its combination with the checkpoint inhibitor. The study includes three initial groups one receiving Bria-IMT plus Retifanlimab, one receiving physicians choice treatment such as eribulin, carboplatin, capecitabine, gemcitabine, vinorelbine, or taxanes, and one receiving Bria-IMT alone. After enrolling 150 patients, the Bria-IMT alone group will be stopped, and those patients may switch to the combination therapy. Treatment cycles for Bria-IMT arms occur every three weeks, with imaging assessments every six weeks twice, then every eight weeks if no disease progression or safety concerns arise. Participants will undergo various assessments throughout the study, including imaging and clinical evaluations, to track overall survival up to 60 months. Secondary outcomes include progression-free survival, clinical benefit rate, overall response rate, quality of life, and central nervous system event-free survival. Safety and treatment effects will be monitored continuously, and participants may be followed for up to five years after starting treatment.

Researchers are evaluating a new medicine called PF-08634404 combined with chemotherapy for adults with colorectal cancer that has spread to other parts of the body. The study aims to understand how well this new combination works compared to an existing treatment using Bevacizumab with chemotherapy. The study is a phase 3, double-blind, randomized trial focusing on treatment effectiveness and safety in participants who have not received prior systemic therapy for metastatic disease. Participants are randomly assigned to one of two groups. One group receives PF-08634404 with chemotherapy, and the other group receives Bevacizumab with chemotherapy. Both treatments are given through intravenous IV infusions in cycles. Treatment continues as long as it helps and side effects are manageable. Treatments are administered at clinical sites by trained staff. Participants will have regular visits for treatment, health evaluations, and various tests. After stopping treatment, there is a follow-up visit about 30 to 37 days later to review health and side effects. Further follow-up occurs every 12 weeks by phone, in person, or via health record review to monitor health status and any new treatments. The study duration for each participant is approximately 33 months. Researchers will measure progression-free survival, overall survival, response rates, quality of life, and monitor safety throughout the study.

Researchers are evaluating the therapeutic cancer vaccine OSE2101 in patients with metastatic non-small cell lung cancer NSCLC who have developed secondary resistance to immune checkpoint inhibitors ICI. This phase 3, multicenter, randomized, open-label study focuses on HLA-A2 positive patients with either squamous or non-squamous NSCLC. The study aims to compare the efficacy and safety of OSE2101 with the standard treatment docetaxel, considering factors like cancer histology and performance status. Participants will be randomized in a 21 ratio to receive either OSE2101 monotherapy or docetaxel monotherapy. OSE2101 is administered as a subcutaneous injection of 5 mg peptides every three weeks for six cycles, then every eight weeks during the first year, and every twelve weeks until the end of the second year. Docetaxel is given as a 75 mgm2 intravenous infusion over one hour every three weeks. Additionally, a companion diagnostic device system is used to assess patient eligibility based on HLA-A2 phenotype. During the study, participants will have regular evaluations including clinical assessments and monitoring of survival time from randomization to death, which is the primary outcome measured over an average of three years. The study involves ongoing monitoring of treatment effects and safety. Participants can expect scheduled visits aligned with treatment cycles and assessments throughout the trial duration, which extends up to nearly five years from start to completion.