Margate

Researchers are conducting a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rilzabrutinib in adults with active Immunoglobulin G4-related disease IgG4-RD. The study aims to measure the time to the first adjudicated disease flare and assess other important outcomes such as flare-free rates, disease activity control, glucocorticoid use, and safety parameters including adverse events, laboratory tests, and electrocardiograms ECG. Participants will be assigned to one of two groups one receiving rilzabrutinib tablets and the other receiving placebo tablets, both administered orally. The treatment period lasts 52 weeks in a double-blind manner, preceded by a 4 to 6 week screening period. After treatment, there is a 2-week follow-up, with an optional open-label extension lasting up to 108 weeks. The study includes a total of 16 visits during the main period and up to 9 additional visits during the optional extension. During their participation, adults diagnosed with IgG4-RD will undergo repeated imaging procedures such as CT, MRI, PET, or ultrasound to assess disease status. Researchers will monitor disease flares, remission status, glucocorticoid dosage, clinical activity scores, laboratory values, vital signs, and ECG results. Safety monitoring continues up to week 160 to capture treatment-emergent adverse events. Overall, participation lasts up to 60 weeks, with possible extension for those continuing in the optional phase.

Researchers are studying LAT010, a new human IL-2 based immunocytokine, in patients with advanced solid tumors to assess its safety, immune response, how the body processes the drug, and its potential antitumor effects. This Phase 12, open-label, multicenter study aims to find an effective dose and evaluate initial efficacy in patients with cancers that have limited treatment options. LAT010 is designed to activate immune cells that fight tumors without causing some of the severe side effects seen with other IL-2 therapies. In Phase 1, patients with locally advanced or metastatic solid tumors will receive intravenous LAT010 once a week in 4-week cycles using a dose-escalation approach to find the maximum tolerated dose or recommended dose for Phase 2. Phase 2 will expand to include patients with specific tumor types receiving LAT010 alone or in combination with a PD-1 inhibitor at doses determined from Phase 1. The study includes up to seven dose groups in Phase 1 and multiple cohorts in Phase 2 to further evaluate safety and antitumor activity. Participants will undergo regular evaluations including lab tests, imaging scans, and monitoring for side effects throughout treatment cycles lasting up to 24 months or longer. Researchers will closely track adverse events, drug levels in the blood, immune responses, and tumor responses following RECIST 1.1 criteria. Safety follow-up will continue for up to 15 months after treatment to assess long-term effects. The total study duration includes initial dose finding and cohort expansion to better understand LAT010s potential in advanced cancer treatment.

Researchers are evaluating the long-term safety and effectiveness of APG777 in adults with moderate-to-severe atopic dermatitis who have completed treatment in a previous APG777 study. This phase 2 extension study involves participants who, according to their doctors, would benefit from continued treatment with APG777. The study is designed as a multicenter, double-blind trial to assess ongoing treatment outcomes and safety over several years. Participants in this study will continue receiving APG777 through three main periods a screening visit coinciding with the last visit of the prior studys maintenance period, an extended treatment period, and a post-treatment follow-up period. Participants who met certain skin improvement criteria and did not use topical rescue medication during the prior study will maintain their previous dose and injection frequency. Those who did not meet these criteria or used rescue medication will receive APG777 according to a specific dosing plan in an open-label escape arm. During the study, participants will be closely monitored for treatment-emergent adverse events up to 3 years. The research team will also measure skin improvements using tools such as the Eczema Area and Severity Index EASI and the Investigator Global Assessment for Atopic Dermatitis vIGA-AD, as well as tracking itch severity, use of rescue therapy, and serum drug concentrations. The overall participation time includes up to 3 years of follow-up to evaluate long-term safety and efficacy outcomes.

Researchers are studying CTX-8371, a new drug given as a monotherapy to patients with advanced cancers that have spread or cannot be removed by surgery. This Phase 1 open-label trial aims to evaluate the safety, tolerability, immune response, and how the drug behaves in the body. It also looks at early signs of the drugs effect on tumors. The study involves patients with several cancer types including non-small cell lung cancer, triple negative breast cancer, Hodgkin lymphoma, head and neck squamous cell carcinoma, and malignant melanoma. Participants are divided into two groups a Dose Escalation group and a Dose Expansion group. In the Dose Escalation group, patients receive increasing doses of CTX-8371 through intravenous infusion every two weeks, testing doses from 0.1 to 10.0 mgkg. The Dose Expansion group receives either 3.0 mgkg or 10.0 mgkg of CTX-8371, also by intravenous infusion every two weeks, allocated evenly between doses. This approach helps find the best dose to study further and assess safety at different levels. During the study, participants receive infusions every two weeks and undergo regular evaluations including tumor assessments using recognized criteria, blood tests to monitor drug levels and immune response, and safety checks. These assessments continue during treatment and for up to two years after the last dose to monitor disease progression, response duration, survival, and drug effects. The study also carefully tracks side effects and overall tolerability, with participation lasting about six months for dose escalation patients and up to two years for dose expansion patients.

Researchers are evaluating the safety and tolerability of DB-1303BNT323 in adults with advanced or metastatic solid tumors that express HER2. This Phase 12a trial focuses on patients with tumors that are advanced, unresectable, recurrent, or metastatic and have limited or no standard treatment options. The study aims to identify the best dose and explore early signs of effectiveness in a variety of HER2-expressing cancers. The trial has two parts an initial dose-escalation phase using an accelerated titration followed by a classic 33 design to find the maximum tolerated dose MTD or recommended Phase 2 dose RP2D, and a dose-expansion phase to further assess safety, tolerability, and potential effects at the established dose. Participants receive DB-1303BNT323 by intravenous infusion once every three weeks Q3W at various dose levels. Some groups are randomized to receive different dose levels or combinations with other drugs like Pertuzumab, Ritonavir, or Itraconazole to study drug interactions and responses. During the study, participants will have regular assessments including monitoring for dose-limiting toxicities, adverse events, and serious adverse events using standard criteria up to about one year after treatment. Researchers will also evaluate tumor responses using RECIST 1.1 criteria and collect pharmacokinetic and pharmacodynamic data. Other evaluations include heart function tests, organ function, and overall health status. The study duration varies per participant, with follow-up visits extending up to one year post-treatment to monitor safety and treatment effects.

Researchers are studying DB-1311BNT324 in adults with advanced solid tumors that have progressed after standard treatments or have no standard options available. This Phase 12a trial aims to evaluate the safety, tolerability, and early effectiveness of DB-1311BNT324, including its use alone or combined with new hormone therapies in prostate cancer. The study also investigates drug interactions with lopinavirritonavir and itraconazole. Participants receive intravenous doses of DB-1311BNT324 every three weeks at different dose levels to identify the best tolerated dose and recommended dose for further study. The trial includes various groups with specific tumor types, such as small cell lung cancer, non-small cell lung cancer, esophageal cancer, prostate cancer, melanoma, liver cancer, cervical cancer, ovarian cancer, head and neck cancer, and rare tumors. Some groups receive DB-1311BNT324 alone, while others receive it combined with oral hormone therapies or other drugs. During the study, participants undergo regular safety checks including vital signs, blood tests, heart function tests, and cancer status assessments. Researchers monitor side effects, serious adverse events, and tumor responses up to about one year after treatment. The main goal is to find the maximum tolerated dose and assess the drugs safety and preliminary antitumor activity. Participants health and cancer are closely followed throughout and after treatment.

Researchers are evaluating dotinurad, an oral drug, to lower serum uric acid levels in adults with gout who cannot tolerate xanthine oxidase inhibitors XOI or whose uricase treatment has failed. This Phase 2 randomized, double-blind, placebo-controlled study aims to assess the drugs effectiveness and safety in this specific population. The primary goal is to see how many participants achieve a serum uric acid level below 6.0 mgdL at 24 weeks. Participants will be divided into two groups. One group will take dotinurad for 36 weeks, split into a 24-week initial period followed by a 12-week continuation. The other group will take a placebo for the first 24 weeks and then switch to dotinurad for the final 12 weeks. Dotinurad is given as an oral tablet, while the placebo capsules contain inactive ingredients. This design allows comparison of the drug against placebo and later observation of dotinurads effects. During the study, participants will have their serum uric acid measured at various points, especially at weeks 16, 20, 24, and up to week 40. Researchers will monitor treatment-emergent adverse events throughout the study period. Participants will be followed from screening through treatment and safety assessments, with the primary focus on uric acid levels at week 24. The total study duration for each participant covers screening and up to 40 weeks of follow-up.

Researchers are studying UGN-104, a new formulation of UGN-101 also known as JELMYTO, to evaluate its effectiveness and safety in treating patients with low-grade upper tract urothelial cancer LG-UTUC. This phase 3, single-arm study focuses on patients with this specific type of cancer affecting the upper urinary tract, aiming to assess how well the treatment works and its safety profile. Participants will receive UGN-104 once a week for six weeks, with each dose administered directly into the upper urinary tract via a ureteral catheter or nephrostomy tube. The dose consists of 4 mg mitomycin per 1 mL sterile hydrogel. After the initial treatment period, patients who have no detectable disease at the primary disease evaluation visit about three months after the first dose may enter a follow-up phase where they could receive monthly maintenance doses for up to 11 months, depending on the investigators decision. During the study, participants will have evaluations every three months to check for disease response or recurrence. These assessments include urine cytology, visual inspection via ureteroscopy, and biopsies if needed. Researchers will monitor the complete response rate at three months as the primary outcome and track the duration of response, durable complete response rate, and any treatment-related side effects for up to 15 months. The total participation time varies depending on response and disease status.

Researchers are evaluating changes in bone mineral density in premenopausal women with heavy menstrual bleeding caused by uterine fibroids or moderate-to-severe pain from endometriosis. This Phase 3B, open-label study looks at the effects of continuous treatment with a relugolix combination tablet for up to 48 months 4 years, followed by a 1-year period to monitor bone health after stopping treatment. Participants will take a daily oral relugolix combination tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg for 4 years. Bone mineral density will be measured every 6 months using dual-energy X-ray absorptiometry DXA. Some women who have completed a previous related study may join to complete 3 years of treatment. After treatment ends, bone density will be checked again at 6 months and 12 months during the follow-up year. Women in the study will have regular visits for bone density scans and health assessments, including physical and gynecological exams, lab tests, and vital signs. Researchers will track changes in bone density at the spine, hip, and femoral neck throughout treatment and follow-up. They will also monitor for any fractures or adverse events during the 4 years of treatment and the 1-year post-treatment period. Total participation can last up to 5 years including the follow-up.

Researchers are conducting a multicenter, randomized, double-blind, parallel-controlled phase I clinical study to compare HLX17 and US-sourced Keytruda in patients with resected non-small cell lung cancer, melanoma, or renal cell carcinoma. The study aims to evaluate how similar the pharmacokinetic profiles, efficacy, safety, and immune responses are between these two treatments in this patient population. Participants will receive either HLX17 or US-sourced Keytruda. Those in the HLX17 group will get 200 mg on Day 1 of every 3-week cycle for up to 12 months or until disease recurrence, death, new anti-tumor therapy, unacceptable toxicity, consent withdrawal, or study end. The Keytruda group will receive 200 mg every 3 weeks for 8 cycles 24 weeks, then switch to HLX17 on the same schedule until 12 months or similar conditions occur. During the study, participants will undergo various assessments including pharmacokinetic measurements such as drug concentration over time and at steady state, disease-free survival evaluation for up to 12 months, and monitoring for adverse events and laboratory abnormalities for up to 15 months. Safety follow-up includes vital signs, physical exams, ECGs, and immunogenicity evaluation. The total study duration includes treatment and safety monitoring phases.