Germantown

Researchers are evaluating the safety and effectiveness of ifinatamab deruxtecan (I-DXd) alone or combined with other treatments in people with metastatic castration-resistant prostate cancer (mCRPC). This study aims to understand how well patients tolerate the treatment, find a safe dose for combining I-DXd with other drugs, and measure prostate-specific antigen (PSA) levels during treatment. The study is part of a larger master screening protocol and includes patients with confirmed prostate adenocarcinoma who have progressive disease despite prior therapies. Participants receive treatments including I-DXd given through intravenous infusion, sometimes combined with other drugs such as docetaxel (IV), MK-5684, abiraterone, or enzalutamide (all oral). Before each I-DXd dose, patients take premedication to prevent nausea and vomiting. The study includes both a safety lead-in phase and an efficacy phase, with ongoing monitoring for side effects and tolerability. The combination therapies are carefully dosed and scheduled according to the study protocol. During the study, participants undergo regular assessments to monitor side effects, measure PSA response, and track any dose-limiting toxicities. Safety is closely followed, particularly during the first 21 days for combination treatments, and throughout up to 54 months for long-term outcomes. Researchers also observe if participants discontinue treatment due to adverse events. The study requires ongoing visits and evaluations to ensure participant health and collect data on treatment effects over time.

Researchers are evaluating new treatments for people with high-risk non-muscle invasive bladder cancer (HR NMIBC), a type of bladder cancer that has not spread to the muscle but has a high chance of worsening or returning. This cancer type may include carcinoma in situ (CIS), which is a flat, surface-level bladder cancer. The study aims to learn whether adding intismeran autogene (V940), a treatment designed to boost the immune system's attack on cancer, to the standard Bacillus Calmette-Guerin (BCG) immunotherapy can help people live longer without the cancer growing, spreading, or coming back. Participants will receive either the combination of V940 with BCG or BCG alone. BCG is given as a bladder instillation, while V940 is given as an intramuscular injection. The study is phase 2, open-label, and randomized. As of a 2026 amendment, outcome measures for a monotherapy arm of V940 are no longer primary or secondary. Treatment is focused on Cohort A, which includes people with high-risk non-muscle invasive bladder cancer who are BCG-naïve or meet specific recurrence criteria. During the study, participants will be monitored for event-free survival for up to approximately 5 years. Researchers will assess how long participants live without the cancer worsening or returning. The study includes regular evaluations, imaging, and safety monitoring. The total duration of participation depends on individual outcomes and follow-up but includes long-term observation to assess treatment effects and safety.

Researchers are evaluating the safety and effectiveness of Alpha DaRT-224, a novel treatment for patients with recurrent cutaneous squamous cell carcinoma who have not responded to standard therapies and are not candidates for surgery or standard radiation. This multicenter, pivotal, single-arm, open-label clinical study aims to determine the objective response rate and duration of response following treatment, as well as assess progression-free survival, overall survival, local tumor control, and quality of life. The treatment involves placing DaRT seeds, which contain a radium-224 source that releases alpha-emitting atoms, directly into the tumor. These seeds remain in the tumor for 14 to 21 days before being removed. The procedure is planned using radiotherapy parameters and monitored with volumetric imaging to ensure proper placement and coverage of the tumor. Participants will undergo evaluations including CT scans and blood tests before and during the study. Researchers will measure tumor response from day 14 through 52 weeks after treatment and monitor safety by tracking adverse events related to the device. The study also includes assessments of quality of life and long-term outcomes over several months. Participants are followed closely to document tumor changes, side effects, and overall health during the study period.

Researchers are evaluating the safety and effectiveness of the FloStent, a medical device designed to treat men experiencing symptoms of Benign Prostatic Hyperplasia (BPH). This clinical study compares the FloStent to a sham procedure, which involves flexible cystoscopy without deploying the device. The purpose is to assess how well the FloStent improves urinary symptoms in men with BPH. Participants will undergo a flexible cystoscopy. Those assigned to the treatment group will have the FloStent deployed during the procedure, while those in the control group will have the cystoscopy without device deployment. The study is designed as a prospective, multicenter, double-blind, randomized trial ensuring unbiased results. During the 12-month study period, researchers will monitor changes in participants' International Prostate Symptom Score (IPSS) to measure symptom improvement. Participants must complete all study visits and protocols as part of their involvement. Safety and effectiveness outcomes will be carefully tracked throughout the trial.

Researchers are conducting a large international, randomized, controlled study to assess the safety and effectiveness of the DurAVR4 biomimetic valve system compared to commercially available Transcatheter Heart Valve (THV) devices from the SAPIEN and Evolut series. This study involves adults with severe native calcific aortic stenosis who are candidates for Transcatheter Aortic Valve Replacement (TAVR). Additionally, a separate group of high surgical risk patients with failed surgical bioprosthetic valves needing valve-in-valve (ViV) TAVR will be enrolled and followed to evaluate the DurAVR4 THV. Participants will be randomized to receive either the DurAVR4 THV or a commercially approved THV device for native valve replacement. Subjects in the ViV registry cohort will receive only the DurAVR4 THV. The randomized native valve cohorts will be followed for up to 10 years, while the ViV cohort will be followed for 5 years. The study will compare clinical outcomes between these treatments over the long term. During the study, participants will undergo regular clinical evaluations including monitoring for death, stroke, and cardiovascular hospitalizations over one year as primary outcomes. The research team will also assess valve function and safety through imaging and other clinical assessments. Written informed consent is required, and participants will be closely monitored throughout the study duration to collect comprehensive safety and effectiveness data.

Researchers are investigating new treatments for advanced ovarian cancer, specifically in patients who do not have homologous recombination deficiency (non-HRD positive). This Phase 3 study aims to assess whether maintenance treatment with sacituzumab tirumotecan (sac-TMT), alone or combined with bevacizumab, can improve progression-free survival compared to the current standard care after initial platinum-based chemotherapy and surgery. Participants receive sacituzumab tirumotecan through intravenous infusion at a dose of 4 mg/kg. Some also receive bevacizumab intravenously at 15 mg/kg as part of their maintenance treatment. Before sac-TMT infusion, participants are given prophylactic steroid mouthwash and recommended rescue medications including histamine-1 and histamine-2 receptor antagonists, acetaminophen or equivalent, and dexamethasone or equivalent. The study compares these treatments to standard care or observation following first-line chemotherapy. During the study, participants are monitored for progression-free survival for up to approximately 49 months. Researchers will assess how long participants live without their cancer getting worse. Throughout the trial, safety and response to treatment are evaluated. The study includes women aged 18 years and older who have completed surgery and first-line chemotherapy with specific responses and meet certain health criteria.

This research aims to learn about the safety and dosing of COM503, a drug being studied alone or combined with zimberelimab, in people with advanced solid tumors. It is a first-in-human Phase 1 clinical trial focused on participants with advanced or recurrent metastatic solid malignancies who have progressed despite standard treatments. The study seeks to assess safety, tolerability, and determine the best doses for future research. Participants will receive COM503 either alone or together with zimberelimab through intravenous infusions. The trial has two parts: dose escalation to find the maximum tolerated or administered dose, and dose expansion to further evaluate safety and dosing at identified levels. Both treatments are given as infusions, and the study monitors how well participants tolerate these therapies. During the study, participants will have their tumors measured by CT or MRI scans and will be closely monitored for safety from the first dose until 90 days after the last dose or start of a new cancer therapy. Researchers will evaluate side effects, tolerability, and other safety outcomes. Participation involves regular assessments and follow-up to understand the effects of COM503 alone or with zimberelimab in advanced cancer settings.

Researchers are evaluating the experimental antibody COM701 in participants with relapsed platinum sensitive ovarian cancer (PSOC). This trial aims to find out if COM701, given as a maintenance treatment, can delay the progression of ovarian cancer, delay the need for new anti-cancer treatments, and to assess its safety. The study is part of an adaptive-platform trial with multiple sub-studies, focusing initially on COM701 alone compared to a placebo. Participants are randomly assigned in a 1:2 ratio to receive either a placebo or COM701 via intravenous infusion every 3 weeks. The trial includes a double-blind, randomized, placebo-controlled design for the first sub-study. Future sub-studies will explore COM701 combined with other anti-cancer drugs. During the study, participants will visit the clinic every three weeks for treatment and monitoring. Health checks include physical exams, vital signs, ECGs, blood and urine tests, and pregnancy tests if applicable. Disease response will be assessed with CT or MRI scans and tumor marker tests using tumor tissue samples. The primary measure is progression-free survival, tracking time from randomization until disease progression or death, assessed up to two years.

Researchers are evaluating intravitreal EYE103 in participants with neovascular age-related macular degeneration (NVAMD) or macular edema following branch retinal vein occlusion (BRVO). This Phase 2, randomized, dose-masked study includes four patient cohorts: treatment-naive NVAMD participants, incomplete responder (IR) NVAMD participants as monotherapy, IR NVAMD participants receiving EYE103 combined with aflibercept 2.0 mg, and treatment-naive BRVO participants. The study aims to assess safety and efficacy of different doses of EYE103 in these conditions. Participants in each cohort will be randomly assigned to receive either a low or high dose of EYE103 via intravitreal injection. All participants will receive three injections spaced four weeks apart. IR NVAMD participants in the combination therapy cohort will also receive an injection of aflibercept 2.0 mg on Day 1. The timing of enrollment into each cohort is determined by the Sponsor. Participants will undergo safety and efficacy assessments at each injection visit, with some cohorts returning two weeks after injections for further evaluations. Assessments include measuring best-corrected visual acuity using the ETDRS chart, slit-lamp biomicroscopy, fundoscopy, and spectral domain optical coherence tomography (SD-OCT) to measure central subfield thickness. The study concludes at Week 12, which is the end-of-study visit for all participants.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of IMP1734, a PARP1 selective inhibitor, in participants with advanced solid tumors. The study aims to assess preliminary efficacy and find the best dosing for future clinical development. This first-in-human trial is conducted in two parts, focusing on patients with recurrent, advanced, or metastatic solid tumors including metastatic prostate, ovarian, breast, and other solid tumors with specific genetic mutations. The trial has two main phases: Part 1 involves dose escalation of IMP1734 as a monotherapy to determine the maximum tolerated or achievable dose in solid tumors. Part 2 focuses on dose optimization to select the optimal dose for further clinical use. Treatment involves oral administration of IMP1734, with dose escalation steps and combination dose escalations in specific cancers like metastatic prostate cancer, ovarian, and breast cancer. Participants will undergo regular assessments to monitor safety through adverse event tracking, pharmacokinetic and pharmacodynamic evaluations, and tumor response measurements using criteria like RECIST1.1, CA125, or PSA. The study includes monitoring for serious adverse events from consent until 30 plus 7 days after the last dose. Dose-limiting toxicities are assessed during the first treatment cycle. Participants are expected to have adequate organ function, a life expectancy of at least 12 weeks, and will be followed closely during the trial to evaluate the drug's safety and potential anti-tumor activity.