Beverly Hills

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 Phase I/II, multi-site, open-label study to evaluate the safety, effectiveness, and optimal dosing of the investigational treatments BNT323 combined with BNT327 in adults with advanced breast cancer. This includes those with hormone receptor-positive or negative types, HER2-positive, HER2-low, HER2-ultralow, HER2-null breast cancer, or triple-negative breast cancer. The study aims to understand how these treatments work alone and together in this patient population. The study has two parts: Part 1 involves dose escalation where participants with chemotherapy-pretreated advanced breast cancer receive BNT323 and BNT327 together to find the recommended Phase 2 dose. Part 2 is an expansion phase that tests the safety and effectiveness of the chosen dose, including randomized comparisons of combination therapy at different doses and monotherapies. Participants may be assigned to one of four treatment arms, with dosing administered via intravenous infusion. Participants will be monitored for dose-limiting toxicities during the first 21 days of treatment, as well as adverse events up to 90 days after the last dose. Tumor response will be assessed for up to 36 months. Evaluations include heart function tests, tumor imaging, safety assessments, and tracking of side effects. The study carefully monitors treatment safety, effectiveness, and participant health throughout the trial duration.

Researchers are evaluating a combination therapy using BNT324, a B7-H3 antibody-drug conjugate, with BNT327, a bispecific antibody targeting PD-L1 and VEGF, in people with advanced or relapsed small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). This two-part Phase Ib/II trial aims to find safe and effective dose levels and to assess the therapy's safety and clinical effects in different lung cancer groups, including treatment-nave and relapsed patients. The study uses a dose escalation design in Part 1 to establish two safe combination dose levels of BNT324 and BNT327. In Part 2, participants receive either the higher or lower recommended dose to determine the optimal dose for further study. Some groups are randomized to one of the two doses, while others receive the highest dose based on prior results. Both drugs are given by intravenous infusion during the treatment period. Participants undergo screening before starting treatment, followed by treatment and safety monitoring. Researchers track dose-limiting toxicities, adverse events, dose adjustments, and treatment discontinuations up to 90 days after treatment ends or until new anticancer therapy starts. They also evaluate objective response rates up to 87 months after the first dose. Ongoing survival follow-up is included to assess long-term outcomes and safety.

Researchers are conducting a Phase 1B open-label dose escalation study to evaluate AV-380 in cancer patients experiencing cachexia, a condition involving severe weight loss and muscle wasting. AV-380 is a monoclonal antibody designed to bind to the growth differentiation factor 15 (GDF-15), a protein involved in cancer-related cachexia. The study aims to assess the safety, how the drug moves through and affects the body (pharmacokinetics and pharmacodynamics), and its potential immune response effects in patients actively receiving standard cancer treatments. Participants will receive increasing doses of AV-380 alongside their standard of care chemotherapy to determine appropriate dosing and monitor for any adverse effects. AV-380, a biological therapy, targets GDF-15 to potentially impact cachexia symptoms. The study involves treatment periods lasting up to four months, with careful observation during drug administration and follow-up visits. Throughout the study, participants will be closely monitored for adverse events, toxicity, and laboratory abnormalities from the time of enrollment through approximately 60 days after the last dose. Safety assessments and laboratory tests will be regularly conducted to evaluate the body's response to AV-380. The study involves active cancer patients with cachexia, with various evaluations to understand the drug's safety profile and effects over the study duration.

Researchers are evaluating the safety and effectiveness of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as initial treatments for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC) whose tumors express PD-L1. This Phase III, randomized, double-blind, global study focuses on patients whose tumors meet the PD-L1 expression threshold of 1% or higher and do not have certain genetic mutations or rearrangements that would require other targeted therapies. Participants receive either rilvegostomig or pembrolizumab intravenously on the first day of each 21-day treatment cycle. Both groups also receive platinum-based chemotherapy drugs such as carboplatin or cisplatin, administered intravenously up to four cycles, along with pemetrexed given intravenously on Day 1 of each cycle. The study monitors these treatments as first-line therapy for metastatic non-squamous NSCLC. During the study, participants undergo regular assessments including imaging scans to measure tumor size and response, as well as evaluations of organ and bone marrow function. Researchers track overall survival and progression-free survival for up to approximately five years. Safety is closely monitored throughout, and patients are followed long-term to assess outcomes related to treatment effectiveness and tolerability.

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

Researchers are evaluating the effects of pelacarsen (TQJ230), given as a monthly injection under the skin, in people with mild to moderate calcific aortic valve stenosis. This study aims to see if pelacarsen can safely slow the progression of this heart valve condition compared to a placebo. The trial is a phase 2, randomized, double-blind, placebo-controlled study conducted at multiple centers. Participants will receive either pelacarsen 80 mg or a matching placebo once a month. Before starting the treatment, they must have elevated lipoprotein(a) levels and be optimally treated for existing cardiovascular risk factors. The study focuses on those aged 50 to under 80 years with mild or moderate calcific aortic valve stenosis. During the 36 months of participation, researchers will monitor changes in peak aortic jet velocity and aortic valve calcium score to assess disease progression. Safety, tolerability, and the impact of the treatment will be evaluated. Participants will undergo regular assessments, including laboratory tests and clinical evaluations, to track heart valve condition and overall health throughout the study.

Researchers are evaluating VENT-03 to see if it can treat adults with active cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). The study also aims to learn about the safety of VENT-03 and how the body processes it. Participants will be compared to those receiving a placebo to determine if VENT-03 affects disease activity and severity, as well as to monitor any side effects. Participants will take either VENT-03 tablets or placebo tablets for 4 weeks in a double-blind phase. After this, all participants will switch to taking VENT-03 for an additional 8 weeks in an open-label extension. The study involves monthly clinic visits for checkups and tests throughout the treatment periods. During the study, researchers will assess the effect of VENT-03 on the interferon gene signature in the skin from baseline to the end of the double-blind treatment (up to Day 28). Participants will have regular evaluations including clinical assessments and safety monitoring to track how the treatment affects their condition and to watch for any side effects or adverse events over the total duration of the study.

Researchers are evaluating CTIM-76, a Claudin-6 directed bispecific antibody, in a Phase 1a/1b open-label study involving people with platinum-refractory or resistant ovarian cancer and other advanced CLDN6-positive solid tumors such as testicular and endometrial cancers. The study aims to assess the safety, tolerability, and effectiveness of CTIM-76, as well as to identify the best dose for further testing. This first-in-human trial includes a dose escalation phase and a dose expansion phase to explore treatment responses and side effects. In the Phase 1a dose escalation phase, participants receive CTIM-76 once weekly on days 1, 8, 15, and 22 of each 28-day cycle. Participants continue treatment until disease progression, unacceptable side effects, or a decision to stop treatment. The Phase 1b dose expansion phase will test CTIM-76 at one or two dose levels or schedules in groups of about 20 participants each, focusing on ovarian, testicular, or endometrial cancer. The recommended dose for further study will be selected based on safety, drug levels, biological effects, and early signs of benefit. Participants will be closely monitored for safety and treatment effects throughout the study. Researchers will assess dose-limiting toxicities up to 28 days after the first dose and measure overall response rates up to 24 months. Evaluations include tumor measurements using RECIST 1.1 criteria, organ function tests, and regular health assessments. The study requires participants to have a good performance status and a minimum life expectancy, with ongoing review to ensure safety and treatment suitability.

Researchers are evaluating the drug OKN4395 given alone and combined with pembrolizumab in patients with advanced solid tumors. This Phase 1 study aims to determine how safe and tolerable OKN4395 is, both by itself and with pembrolizumab, while also measuring drug levels in the blood and the drug's cancer-fighting effects. The study includes patients with various solid tumors, including sarcoma, pancreatic adenocarcinoma, non-small cell lung cancer, colorectal cancer, and head and neck squamous cell carcinoma, especially when other treatments have failed or are not suitable. The study has two parts. Part 1a tests increasing doses of OKN4395 alone or with pembrolizumab given on day 1 every 21-day cycle, with doses rising after safety reviews, ranging from 10 mg twice daily up to 450 mg twice daily. Part 1b involves five groups focusing on specific cancers, with some receiving OKN4395 alone and others combined with pembrolizumab. In Part 1b, some groups will explore how food or stomach pH affects the drug's blood levels. Treatments include oral OKN4395, intravenous pembrolizumab every three weeks, and some participants may receive famotidine or food before dosing. Participants will be closely monitored for side effects, including dose-limiting toxicities, treatment-emergent adverse events, serious adverse events, ECG abnormalities, and lab test changes over up to 27 months in Part 1a and about 12 months in Part 1b. Tumor response will also be measured. Regular blood tests, biopsies, and imaging will be done, and participants must be able to swallow the oral drug and comply with study requirements. The study plans to enroll about 166 participants across multiple countries including the US, Australia, UK, and EU.