West Palm Beach

Researchers are evaluating the long-term safety and tolerability of LB-102 in adults with stable schizophrenia who have had inadequate responses, side effects, or issues with their current antipsychotic medications, or who have completed prior LB-102 studies. This Phase 3, open-label, multicenter trial focuses on patients aged 18 to 65 years with stable disease and aims to provide extended monitoring of this treatment. Participants will receive LB-102 with flexible dosing ranging from 50 mg to 100 mg. This single-group study involves administering the drug openly over 52 weeks to assess how well patients tolerate it and to monitor safety during this period. Throughout the study, participants will undergo evaluations including monitoring adverse events and treatment-emergent events. Effectiveness will be assessed using the Positive and Negative Syndrome Scale PANSS. The study lasts up to 52 weeks, during which safety and tolerability are carefully observed and recorded.

Researchers are studying treatments for locally advanced or metastatic colorectal cancer mCRC that cannot be removed by surgery and has a specific KRAS G12C gene mutation. This trial aims to evaluate if adding the targeted therapies calderasib and cetuximab to the standard chemotherapy regimen mFOLFOX6 can provide better outcomes compared to mFOLFOX6 with or without bevacizumab. The study focuses on the safety and tolerability of these combinations and whether they can help people live longer without their cancer growing or spreading. Participants will be assigned to one of two groups. One group will receive calderasib orally, cetuximab every two weeks, and mFOLFOX6 chemotherapy including oxaliplatin, leucovorin or levofolinate calcium, and 5-fluorouracil every two weeks. The other group will receive mFOLFOX6 chemotherapy with or without bevacizumab every two weeks, based on the investigators decision. Treatments will continue until certain stopping criteria are met. During the study, participants will be monitored for side effects and treatment tolerance, with regular assessments of cancer progression. Researchers will measure outcomes such as dose-limiting toxicities, adverse events, progression-free survival, and overall survival. Quality of life will also be evaluated through questionnaires. The study may last up to several years, with monitoring continuing for safety and effectiveness throughout the treatment period and follow-up.

Researchers are evaluating new treatment options for people living with HIV-1 Human Immunodeficiency Virus Type 1 who have not been treated before. The current standard treatment, antiretroviral therapy ART, involves taking multiple medicines daily and may cause other health problems. This study aims to compare a new study ART combining two medicines, islatravir and ulonivirine, taken once a week, against the standard daily ART to see if it works as well and is safe and tolerable. Participants will receive one of several treatments for 96 weeks the study ART with islatravir and ulonivirine taken once weekly, the standard ART with bictegraviremtricitabinetenofovir alafenamide BICFTCTAF taken once daily, or combinations involving placebos matching these treatments. The study includes two phases Phase 2 which is open-label, and Phase 3 which is double-blind and randomized. During the study, participants will have regular assessments including measuring the amount of HIV-1 RNA in their blood and monitoring for adverse events and medication tolerance. Researchers will evaluate how well the treatments control the virus and affect immune cells over 24, 48, and 96 weeks. Safety monitoring will continue for about 102 weeks. The total study duration for participants is up to 96 weeks of treatment plus follow-up.

Researchers are investigating new treatments for metastatic cervical cancer, which is cancer that has spread beyond the cervix, the lower part of the uterus. This study evaluates the safety and effectiveness of the antibody drug conjugate sacituzumab tirumotecan sac-TMT combined with pembrolizumab and bevacizumab. The goal is to find out if these treatments, given together or with some variations, help patients live longer or delay cancer progression compared to standard care. The study has two parts. In Part 1, participants receive sac-TMT, pembrolizumab, and bevacizumab together to assess safety. In Part 2, all participants first get standard induction treatment with pembrolizumab, paclitaxel, and cisplatin or carboplatin, possibly with bevacizumab. Those whose cancer does not worsen then enter maintenance treatment, where they are randomly assigned to receive either pembrolizumab alone or sac-TMT plus pembrolizumab, with optional bevacizumab. Participants are involved for up to about 20 months during maintenance treatment after up to 4 months of induction. The study monitors safety by tracking side effects and treatment discontinuations. Effectiveness is measured by progression-free survival and overall survival up to several years. Quality of life and physical functioning are also assessed through questionnaires. Treatments and evaluations occur through regular intravenous infusions and periodic monitoring visits.

Researchers are evaluating the effect of Xeomin injections compared to placebo injections for preventing chronic migraine. This Phase 3, randomized, double-blind, placebo-controlled trial includes an extension period and aims to measure changes in the number of monthly migraine days. Participants have chronic migraine and meet specific criteria related to headache frequency and migraine history. Participants receive Xeomin or placebo injections into muscles of the head and neck at pericranial and cervical points. The study includes two Xeomin dose groups and a placebo group during the controlled period, with all groups receiving Xeomin in the extension phase. Four treatments are given approximately 12 weeks apart over a total study duration of 52 to 55 weeks. Participants take part in 14 visits over the study period, with the first, last, and four treatment visits conducted in person and the remaining eight visits by phone or video call. Researchers collect headache and migraine data from diaries and assess changes in monthly migraine days as the primary outcome. Safety is monitored by tracking treatment-related adverse events throughout the trial.

Researchers are evaluating the use of Xeomin injections to prevent episodic migraine. This Phase 3 clinical trial compares Xeomin to placebo injections in the muscles of the head and neck to measure changes in the number of monthly migraine days. Participants have episodic migraine with or without aura, and the study aims to assess the efficacy and safety of different Xeomin doses over time. Participants receive a series of four Xeomin or placebo injections spaced about 12 weeks apart. The study includes two experimental groups receiving different Xeomin doses and a placebo group, followed by an extension period where some participants receive Xeomin. Injections are given at specific points around the head and neck. The trial lasts approximately 52 to 55 weeks, starting with a 4 to 5 week screening period. Participants attend about 14 visits, including the first and last visits and four treatment visits conducted on-site, with other visits done remotely by phone or video call. Researchers monitor changes in monthly migraine days, headache days, and medication use, as well as any treatment-related side effects throughout the study.

Researchers are evaluating the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma LA-HNSCC who have not progressed after receiving definitive concurrent chemoradiotherapy cCRT. This phase III, randomized, open-label global study aims to assess whether volrustomig can improve outcomes in this patient population. Participants are randomly assigned to one of two groups those who receive volrustomig as sequential therapy, and those who undergo observation without additional treatment. The study compares these two approaches following prior curative concurrent chemoradiotherapy. The trial includes long-term follow-up to monitor patient outcomes. During the study, participants will be regularly assessed for progression-free survival, overall survival, physical functioning, and quality of life. Researchers will also monitor for the presence of anti-drug antibodies and adverse events related to volrustomig. Follow-up evaluations may continue for up to approximately eight years to fully understand the treatment impact and safety profile.

Researchers are evaluating the safety, tolerability, how the body processes pharmacokinetics, how the body responds pharmacodynamics, and effectiveness of TERN-701, a selective inhibitor targeting BCR-ABL1, in adults with chronic phase chronic myeloid leukemia who have received prior treatment. This Phase 12 trial focuses on participants with treatment challenges such as resistance or intolerance to previous therapies. The study is sponsored by Terns, Inc. and aims to better understand TERN-701s impact in this patient group. The trial has two main parts. Part 1 involves dose escalation where participants receive increasing doses of TERN-701 once daily to determine safe and effective dose levels. Part 2 includes randomized dose expansion cohorts to further assess safety and efficacy at two selected doses from Part 1, and an additional mutation cohort Part 2m evaluating a specific 500 mg dose in participants with certain resistance mutations. Treatment is given continuously in 28-day cycles with scheduled clinic visits at specified days during the first cycle and then on Day 1 of subsequent cycles. Participants will be closely monitored through regular visits for safety, tolerability, and response to treatment. Researchers will evaluate dose-limiting toxicities, adverse events, hematologic and molecular responses, and changes in BCR-ABL1 transcript levels over up to three years. Approximately 180 participants are expected to enroll, contributing to comprehensive data collection on TERN-701s performance and safety in this chronic leukemia population.

Researchers are evaluating zanidatamab for treating adults with previously treated solid tumors that overexpress the HER2 protein at a high level IHC 3. This Phase 2 study focuses on participants whose tumors have progressed after at least one prior systemic treatment and who have no other confirmed beneficial treatment options. The study excludes certain cancers like biliary tract cancer and considers prior HER2 therapy differently across tumor cohorts. Participants receive zanidatamab through intravenous infusion. The study includes a single treatment group with no placebo comparison. Treatment continues as per protocol with monitoring for responses and safety. The study collects tumor samples centrally to confirm HER2 status and requires measurable disease for evaluation. Various cohorts have specific prior treatment requirements. During the study, participants undergo assessments including tumor response evaluation by independent review and investigators using standard criteria RECIST 1.1. The trial monitors treatment safety, side effects, drug levels in the blood, and immune reactions to the drug. Participants will be followed for up to 2.5 years for response and safety, and overall survival is tracked for up to 3.5 years, with regular visits to assess health status and treatment effects.

Researchers are evaluating zelquistinel, a drug aimed at reducing symptoms of major depressive disorder in adults aged 18 to 64 years. This Phase 2 clinical trial compares the effects and safety of zelquistinel to a placebo in participants diagnosed with major depressive disorder. The study will focus on changes in depression severity and monitor any medical issues that arise during treatment. Participants will take one tablet of either zelquistinel or placebo once a week for six weeks. The trial includes a screening period of up to 28 days, followed by a 42-day treatment phase, and then a four-week follow-up period. During treatment, participants will visit the clinic weekly to receive their dose and have their depression symptoms assessed using the Hamilton Depression Rating Scale-17. Throughout the study, participants will have their depression severity regularly evaluated, along with monitoring for adverse events or side effects. The study lasts up to 98 days, including screening, treatment, and follow-up. Researchers will measure changes in depression scores from the beginning to the end of treatment and monitor overall safety during this time.