Malvern

Researchers are evaluating MK-2214, a study treatment designed to slow brain changes in people with early Alzheimers disease AD. AD is a form of dementia that causes memory loss, communication difficulties, and challenges in decision-making, affecting daily tasks. This phase 2 trial aims to determine if MK-2214 slows the spread of tau protein in the brain compared to a placebo, as well as to assess the safety and tolerability of MK-2214. Participants will be randomly assigned to receive either MK-2214 or a placebo through intravenous IV infusion every 4 weeks during the study. The study uses a parallel design with quadruple masking to compare the effects of the study drug versus placebo over a period of up to approximately 23 months. Both groups receive infusions on the same schedule to maintain the studys integrity. During the study, participants will undergo brain scans including positron emission tomography PET to measure tau protein levels and other assessments such as cognitive and daily living function tests. Researchers will monitor adverse events and treatment discontinuations throughout the study, which lasts up to about 26 months. These assessments help determine the impact of MK-2214 on disease progression and safety in individuals with early AD.

Researchers are evaluating BG-C137, an antibody-drug conjugate targeting FGFR2b, in people with advanced solid tumors. This study aims to assess the safety, tolerability, how the drug moves and acts in the body, and early antitumor effects. It is a phase 1ab trial involving participants with tumors expressing FGFR2b or FGFR2 gene amplification who have received prior cancer treatments. The study is sponsored by BeOne Medicines and includes two main phases dose escalation and dose expansion. The trial has three parts Phase 1a evaluates increasing doses of BG-C137 alone and then in combination with other anticancer agents to establish safe dose levels. Phase 1b further explores the recommended dose in selected patient groups. BG-C137 and anticancer agents are given intravenously or orally depending on the treatment. Participants undergo dose escalation, safety expansions, and dose confirmations to determine the best dosing for further study. Participants will be monitored regularly for side effects and response to treatment for up to about two years. Assessments include measuring adverse events, drug levels in the blood, tumor response, and immune reactions to the drug. Safety follow-up visits occur after treatment ends. Researchers will measure outcomes such as maximum tolerated dose, overall response rate, disease control, and progression-free survival. The trial involves frequent visits for treatment and assessments throughout the study period.

Researchers are studying BG-C0979, a drug being evaluated alone or combined with tislelizumab in adults with advanced solid tumors. The study includes early phases to test safety, dosage, how the drug moves in the body, and initial anti-tumor effects. Participants have advanced, metastatic, or unresectable tumors, with some having prior treatments and others being treatment-naive depending on the study phase. Participants receive BG-C0979 through intravenous infusion in different doses during Phase 1a dose escalation and safety expansion. Later, Phase 1b includes dose optimization and expansion of BG-C0979 alone, as well as combination therapy with tislelizumab for select tumor types. The study evaluates increasing doses, determines recommended doses for future studies, and compares monotherapy with combination therapy. Participants undergo regular assessments including tumor measurements using RECIST criteria, performance status evaluation, blood tests, and monitoring for side effects over up to 24 months. Researchers track how the drug is processed in the body, adverse events, tumor response, progression, and survival. This includes frequent safety and laboratory monitoring during treatment to understand tolerability and impact on tumors.

Researchers are evaluating D3S-003, an oral drug, in a first-in-human Phase 1 trial for people with advanced solid tumors that have a KRAS p.G12D mutation. This open-label, multicenter study aims to assess the drugs safety, tolerability, how the body processes it, and early signs of effectiveness in this group of patients who have already tried standard therapies without success or for whom standard options are unsuitable. The trial includes two parts of dose escalation Part 1a with once daily dosing and Part 1b with twice daily dosing of D3S-003. Participants will receive the drug orally, and the study will determine the maximum tolerated dose and recommended Phase 2 dose by monitoring dose-limiting toxicities over cycles lasting 21 days each. This trial will continue for up to approximately 7 months, with the dose adjusted to evaluate safety and preliminary efficacy. Participants will be closely monitored from screening through treatment and up to 30 days after the last dose for adverse events. Assessments include measuring drug levels in the blood at various times, evaluating tumor response according to RECIST v1.1 criteria, and tracking progression-free survival. The study is sponsored by D3 Bio Wuxi Co., Ltd and will last until January 2028, with participants undergoing regular evaluations to ensure their safety and to measure how well the drug works against their tumors.

Researchers are studying a treatment approach for adult men with PSMA-positive metastatic castration resistant prostate cancer mCRPC who have previously received one androgen receptor pathway inhibitor ARPI and may or may not have had taxane chemotherapy. This phase IbII trial aims to first evaluate the safety, tolerability, and how the body processes the drug AMO959 combined with lutetium 177Lu vipivotide tetraxetan AAA617 and ARPI. Then, it will assess the preliminary effectiveness of this combination in patients who have not yet been treated with taxane chemotherapy for mCRPC. The study includes two phases Phase Ib with small groups receiving escalating doses of AMO959 alone, then combined with AAA617 and ARPI abiraterone or enzalutamide to determine the recommended dose and Phase II where participants are assigned to treatment arms receiving AMO959 with AAA617 and ARPI, AAA617 with ARPI, or other dosing regimens. Treatments involve taking AMO959 twice daily for 14 days followed by combinations with AAA617 every six weeks for up to six cycles, along with continuous ARPI therapy. Participants will undergo safety monitoring for side effects and dose adjustments during treatment lasting up to about two years. The study measures include biochemical responses like PSA levels, progression-free survival, overall response rates, and quality of life assessments. Blood samples will track drug levels and radiation doses. Follow-up continues to monitor adverse events and disease progression for up to nearly four years from treatment start, with regular visits during treatment cycles.

Researchers are evaluating HMBD-001, an anti-HER3 antibody, in combination with cetuximab with or without docetaxel for people with advanced squamous cell cancers. This Phase IbII, open-label, multi-center study focuses on various types of advanced or metastatic squamous cell carcinomas, including lung, head and neck, esophageal, cervical, cutaneous, and nasopharyngeal cancers. The study aims to assess the safety and effectiveness of these treatments in participants who have limited standard care options. Participants receive HMBD-001 intravenously once a week alongside cetuximab weekly, with or without docetaxel administered every three weeks. There are three treatment arms one with HMBD-001 plus docetaxel, one with HMBD-001 plus docetaxel and cetuximab both closed to recruitment, and one with HMBD-001 plus cetuximab. The trial evaluates different combinations to understand their effects on advanced squamous cell cancers. During the study, participants are monitored for adverse events and dose-limiting toxicities. Researchers track progression-free survival up to six months and measure tumor response using established criteria. Blood samples are collected to study the drugs behavior in the body and immune response. The study includes repeated treatment cycles and safety follow-up, with assessments continuing up to 48 months. Participants undergo tumor biopsies and organ function tests to ensure safety and gather comprehensive data.

Researchers are evaluating the safety and preliminary effectiveness of THN391 in people with diabetic macular edema DME related to non-proliferative diabetic retinopathy. This Phase 1b study focuses on how different doses of THN391 affect vision and retinal swelling in this eye condition. Participants will be enrolled into three groups receiving escalating doses of THN391 through intravitreal IVT injections. Each participant will receive three monthly injections of THN391 at low, medium, or high doses. The study is open-label and sequential, meaning all participants and researchers know the treatment given, and dosing increases with each group. During the study, participants will be monitored for adverse events for up to 16 weeks after their first injection. Researchers will also measure changes in visual acuity and retinal edema to assess treatment effects. Participation involves multiple visits for injections and assessments over approximately 4 months.

Researchers are evaluating ATG-022 in patients with advanced or metastatic solid tumors in this Phase I, multi-center, open-label clinical trial. The study aims to find the best dose of ATG-022 and to assess its safety and how well it is tolerated. The trial includes patients whose tumors have progressed despite standard treatments or who cannot undergo standard therapies, with a focus on solid tumors and those expressing Claudin 18.2 in the Dose Expansion Phase. The study consists of two main parts a Dose Escalation Phase and a Dose Expansion Phase. In the Dose Escalation Phase, patients receive ATG-022 in cycles of 21 days, starting with a low dose of 0.3 mgkg every three weeks, increasing through defined dose levels to find the maximum tolerated dose. The Dose Expansion Phase enrolls up to 120 patients with Claudin 18.2-positive tumors at the recommended dose to further evaluate safety and efficacy. Participants will undergo biopsies if recent tumor samples are unavailable and must have measurable tumors per RECIST v1.1 criteria. Researchers will monitor side effects and dose-limiting toxicities within 21 days and assess progression-free survival, overall response rate, and duration of response up to 12 months after the last patient is enrolled. Women of childbearing potential and men must use contraception during and after the study. The total participation time varies depending on treatment and follow-up schedules.

Researchers are evaluating the safety, tolerability, how the body processes and responds to BG-75098 alone and combined with BGB-43395 and fulvestrant in adults with advanced solid tumors. This Phase 1a1b study aims to understand these effects and preliminary antitumor activity in participants with advanced, metastatic, or unresectable solid tumors, including those who have progressed after other treatments. The study has two phases Phase 1a involves dose escalation where increasing doses of BG-75098 are tested alone and in combination with BGB-43395 and fulvestrant. Phase 1b involves dose expansion where participants receive BG-75098 at the recommended dose from Phase 1a either alone or combined with the other drugs. BG-75098 and BGB-43395 are given orally, while fulvestrant is given by injection. Participants will be monitored for adverse events, drug levels in the blood, and tumor response up to approximately two years. Assessments include pharmacokinetics, pharmacodynamics, and measuring tumor shrinkage or control. Safety and tolerability will be followed from the first dose through 30 days after the last dose, with ongoing evaluations during treatment cycles and follow-up periods up to two years.

Researchers are evaluating BMS-986340 alone and combined with nivolumab, docetaxel, or pumitamig in people with advanced solid tumors. This first-in-human study aims to assess the safety, tolerability, and recommended doses of BMS-986340 in participants with various advanced cancers who have progressed after standard treatments. This study includes different phases and treatment parts to explore dosing and effects. Participants receive BMS-986340 either as monotherapy or combined with nivolumab, docetaxel, or pumitamig at specified doses on scheduled days. The study includes dose escalation and expansion phases for each treatment combination. The treatments are given sequentially, with participants assigned randomly to different parts of the study to evaluate safety and dosing. During the trial, participants undergo tumor biopsies for biomarker analysis and have measurable disease per standard criteria. Researchers monitor adverse events, serious side effects, and dose-limiting toxicities up to 120 weeks. Pharmacokinetics, immune responses, and tumor responses are regularly assessed. Participants are followed for safety, disease control, and progression-free survival for up to 120 weeks.