Santa Maria

Researchers are evaluating the safety and effectiveness of HLX22 combined with trastuzumab and chemotherapy as the first treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 2, double-blind, randomized, and multiregional study compares this combination against trastuzumab and chemotherapy with or without pembrolizumab. The study aims to measure how well the treatments work in controlling the disease and improving survival for up to five years. Participants will be randomly assigned to one of two groups. One group receives HLX22 at 15 mg/kg every three weeks along with trastuzumab, chemotherapy (XELOX regimen), and possibly a placebo for pembrolizumab. The other group receives a placebo for HLX22 plus trastuzumab, chemotherapy (XELOX), and possibly pembrolizumab every three weeks. Treatment continues until the disease worsens, unacceptable side effects occur, withdrawal of consent, or other protocol-specified reasons. Throughout the study, participants will undergo regular assessments including tumor scans reviewed by an independent committee to evaluate progression-free survival and overall survival over up to five years. Other evaluations include safety monitoring and organ function tests. The study tracks how long patients live without disease progression and overall survival, aiming to better understand the benefits and risks of HLX22 combined with current standard treatments.

This trial is focused on adults with KRAS/NRAS and BRAF wild-type unresectable or metastatic left-sided colorectal cancer. It compares the length of time participants remain free from disease progression when treated with amivantamab combined with chemotherapy regimens (mFOLFOX6 or FOLFIRI) versus cetuximab combined with the same chemotherapy regimens. The study is a randomized, open-label Phase 3 clinical trial designed to evaluate progression-free survival over a period of up to 4 years and 2 months. Participants receive either amivantamab with chemotherapy drugs including 5-fluorouracil, leucovorin calcium or levoleucovorin, oxaliplatin, or irinotecan hydrochloride, or cetuximab with the same chemotherapy regimens (mFOLFOX6 or FOLFIRI). Treatments are administered as first-line therapy for their colorectal cancer. The trial assesses how these treatments affect disease progression and survival. During the study, participants will be monitored regularly through assessments and evaluations to measure progression-free survival. Researchers will gather data via blinded independent central review to ensure unbiased assessment of disease status. Participants are followed up for safety and treatment efficacy over the study duration, which may last over four years.

Researchers are assessing the safety and effectiveness of Pumitamig combined with chemotherapy compared to Nivolumab combined with chemotherapy in adults with untreated advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. This phase 2/3 study focuses on participants with specific tumor characteristics, including PD-L1 status and HER2-negative cancer, aiming to provide new treatment options for this serious condition. Participants receive either Pumitamig along with chemotherapy drugs Folfox or Capox, or Nivolumab combined with chemotherapy, each given at specified doses on set days. The study is randomized and blinded, involving two parts: phase 2 and phase 3, with treatment tailored based on PD-L1 expression levels. During the study, researchers monitor tumor response using RECIST v1.1 criteria, track progression-free survival up to about 33 months, and overall survival up to approximately 47 months after randomization. Assessments include imaging and clinical evaluations to measure treatment effects and safety over the course of participation, which may last up to 2 years or more for certain outcomes.

The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months.

Researchers are investigating a treatment approach for patients hospitalized with community-acquired pneumonia (CAP), a condition with high rates of illness and death. This phase 3 trial compares therapeutic-dose heparin versus usual care pharmacological thromboprophylaxis to see if it improves patient outcomes. The study focuses on preventing complications caused by blood clots and inflammation that can worsen respiratory and organ function in CAP patients. Previous findings in COVID-19 pneumonia suggest heparin might reduce disease progression and mortality, but its effects in non-COVID-19 CAP are unknown. Participants will receive either therapeutic-dose heparin, preferably a low molecular weight heparin (LMWH) like enoxaparin, dalteparin, or tinzaparin, dosed by patient weight unless contraindicated. Intravenous unfractionated heparin (UFH) may be used instead, especially for those with kidney issues, with dosing adjusted to specific blood clotting targets. The trial is open-label and randomized, with adaptive rules to monitor progress. Usual care pharmacological thromboprophylaxis is the comparator. Treatment and monitoring occur during hospital admission, anticipated to last at least 72 hours after randomization. During the study, patients are assessed for survival at 30 days and monitored for complications related to CAP. Researchers collect clinical data including oxygen use, laboratory tests, and adverse events, tracking safety and effectiveness. The study excludes patients with active COVID-19, recent bleeding, contraindications to anticoagulation, or those receiving critical care interventions. Overall participation depends on hospital stay length and clinical status, with follow-up to evaluate the primary outcome of survival within a month.

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.

Researchers are evaluating two different consolidation chemotherapy regimens following neoadjuvant chemoradiation therapy (nCRT) in patients with distal rectal cancer. This study aims to compare fluoropyrimidine-alone chemotherapy with fluoropyrimidine plus oxaliplatin chemotherapy to determine their effects on primary tumor response and the possibility of organ preservation through a Watch and Wait (WW) approach. The trial is a multi-center, prospective randomized controlled study focused on patients with magnetic resonance (MR)-defined distal rectal tumors classified as mrT2-3N0-1 and located no more than 1 cm above the anorectal ring.

Researchers are investigating the requirements for four essential amino acids—Isoleucine, Leucine, Valine, and Tryptophan—in neonates who are fed total parenteral nutrition (TPN). The study is conducted at two hospitals in Brazil and uses the Carbon Oxidation method to measure how these amino acids are processed in the body. It is expected that the needed amounts of these amino acids may be at least 50% lower than what is currently provided in commercial TPN solutions for neonates. Each baby will participate in a protocol where they receive one or two levels of the amino acid being studied over two days. On the first day, babies get a standard pediatric amino acid solution along with a labeled bicarbonate to measure carbon dioxide production. On the second day, they receive a TPN test solution with varied amounts of the specific amino acid plus a small labeled amount of phenylalanine to track amino acid oxidation. Breath and urine samples will be collected, and small blood samples will be taken alongside routine clinical blood work. Participants will be stable preterm neonates on TPN, and the study will collect breath, urine, and blood samples to analyze amino acid oxidation and plasma concentrations. The main outcome is measuring amino acid oxidation over 48 hours. The total participation period includes two consecutive days of intervention and monitoring, with careful clinical assessments to ensure safety and stability throughout the study.

Researchers are evaluating the long-term safety and effectiveness of pembrolizumab (MK-3475) in participants with advanced solid tumors or blood cancers who have previously taken part in other pembrolizumab-based studies. This phase 3 study includes participants who are either currently on treatment or in follow-up from prior parent studies. It aims to understand how well pembrolizumab works over an extended period, up to approximately 10 years, by observing overall survival and safety outcomes. The study has three phases: First Course Phase, Survival Follow-up Phase, and Second Course Phase. Participants who were receiving pembrolizumab, pembrolizumab-based combinations, or lenvatinib in their parent studies will continue treatment in the First Course Phase, completing up to 35 doses every 3 weeks or 17 doses every 6 weeks. Those in the Follow-up Phase will enter the Survival Follow-up Phase without additional treatment but will be monitored. Participants eligible for a Second Course Phase, who have not received other anticancer treatments since their prior pembrolizumab dose and meet health criteria, may receive up to 17 doses every 3 weeks or 8 doses every 6 weeks of pembrolizumab or its combinations. Some may also receive other study drugs such as olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Participants will be involved in regular treatment visits, safety checks, and long-term monitoring for up to about 10 years to assess overall survival. Researchers will evaluate clinical outcomes, monitor any side effects, and check organ function and physical health status. The study includes detailed eligibility screening, including physical assessments and adherence to contraception requirements for women of childbearing potential. Safety follow-up is ongoing to ensure participant well-being throughout the study.

Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and early anti-tumor effects of trastuzumab deruxtecan (T-DXd) alone or combined with chemotherapy and/or immunotherapy in adults with HER2-expressing advanced or metastatic gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma. This Phase 1b/2 study tests whether these combinations at the recommended phase 2 dose show manageable safety and promising anti-tumor activity to support further clinical testing. Participants receive T-DXd either as monotherapy or combined with drugs such as fluorouracil (5-FU), capecitabine, durvalumab, oxaliplatin, trastuzumab, cisplatin, pembrolizumab, volrustomig, or rilvegostomig. Most drugs are given by intravenous infusion, except capecitabine which is taken orally. The study includes dose escalation and expansion parts and covers multiple treatment arms based on HER2 status and prior therapy, with treatment details tailored per study part. During the study, participants undergo regular safety assessments including monitoring for adverse events, dose-limiting toxicities, laboratory tests, vital signs, and electrocardiograms up to approximately 24 months. Efficacy is measured by confirmed tumor response per RECIST criteria over about 12 months. Researchers also collect pharmacokinetic and immunogenicity data to understand drug behavior and immune response. This comprehensive monitoring supports evaluation of safety and preliminary effectiveness in this patient population.