Chicago Ridge

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 zanidatamab, a drug administered through intravenous infusion, for its safety and effectiveness in treating adults with solid tumors that overexpress the HER2 protein. This includes various cancers such as breast, gastric, esophageal, colorectal, lung, ovarian, and pancreatic cancers. The study is a Phase 2, open-label, multicenter trial focusing on participants who have previously received treatment but have limited options available. Participants will receive zanidatamab and be monitored for its effects on their tumors. To be eligible, participants must have HER2 overexpression confirmed by a central lab, measurable tumors, and meet specific health criteria including performance status and organ function. The study excludes those with certain infections, prior treatments with HER2 therapies in some groups, or serious medical conditions. The trial allows participants with treated and stable brain metastases under defined conditions. During the study, researchers will regularly assess tumor response using imaging reviewed centrally, following RECIST 1.1 criteria, over a period of up to 2.5 years. Additional evaluations include health status, safety monitoring, and laboratory tests. Participants must agree to pregnancy prevention measures if applicable. The study aims to measure the confirmed objective response rate to zanidatamab and monitor safety throughout the treatment period.

This research aims to evaluate the effects and safety of ASP5541, a new form of abiraterone acetate given as a muscle injection, in men with advanced prostate cancer. The study focuses on men with metastatic hormone-sensitive prostate cancer (mHSPC) and metastatic castration-resistant prostate cancer (mCRPC), including Japanese men. It compares ASP5541, with or without the steroid prednisone/prednisolone, to the standard oral abiraterone acetate with prednisone/prednisolone. The goal is to see how well ASP5541 works and its safety profile compared to current treatments. Participants are divided into three groups. Group 1 includes men with mCRPC not previously treated with androgen receptor pathway inhibitors (ARPIs), receiving either ASP5541 with prednisone/prednisolone or abiraterone acetate with prednisone/prednisolone. Group 2 includes men with mHSPC not previously treated with ARPIs, receiving either ASP5541 alone or abiraterone acetate with prednisone/prednisolone. Group 3 includes Japanese men with mCRPC or mHSPC who may have prior ARPI treatment, receiving ASP5541 with prednisone/prednisolone. ASP5541 is given as an injection every 12 weeks, prednisone/prednisolone is taken orally once or twice daily depending on cancer type, and abiraterone acetate is taken as daily tablets. All groups continue standard androgen deprivation therapy. During the study, men will visit clinics regularly for health checks, cancer scans, and safety monitoring. Some men in Group 2 will monitor blood pressure weekly at home. Researchers will track prostate specific antigen (PSA) levels, adverse events, vital signs, and lab tests for up to 37 months. The study evaluates how well ASP5541 lowers PSA compared to abiraterone acetate and monitors for side effects and overall health status throughout treatment and follow-up.

Researchers are investigating whether treating children with amblyopia using spectacles and patching at the same time leads to similar vision improvement compared to treating first with spectacles alone and then adding patching if needed. This randomized Phase 3 trial focuses on children aged 3 to under 13 years who have not been treated for amblyopia before. The study looks at amblyopia caused by differences in eye focusing (anisometropia), eye misalignment (strabismus), or both. At the start, children's vision will be tested with trial glasses based on a recent eye exam. Eligible children will receive new glasses and return for a baseline visit after wearing them for at least 10 minutes to confirm eligibility. Then they will be randomly assigned to either the sequential group (glasses first, patching added if needed) or the simultaneous group (glasses and patching together). Follow-up visits will happen every 8 weeks for up to 56 weeks, with vision tested each time to track improvement or stability. Patching will be monitored using an occlusion dose monitor (ODM). Throughout the study, vision in the amblyopic eye will be regularly measured to assess changes. Participants will be categorized as improving or stable/worsening at each visit. Those with stable or worsening vision and remaining amblyopia in the sequential group will begin patching and continue follow-up visits. Treatment adjustments will be made based on investigator judgment. The main outcome is the average change in distance visual acuity in the amblyopic eye after 56 weeks of treatment. The study ends after the final 56-week visit.

Researchers are evaluating the safety and effectiveness of divarasib combined with pembrolizumab compared to pembrolizumab with pemetrexed and either carboplatin or cisplatin. The study focuses on adults with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has a specific KRAS G12C mutation. This is a Phase III trial aiming to improve first-line treatment options for these patients. Participants will receive one of two treatment combinations. One group will take divarasib orally once daily along with pembrolizumab given through an intravenous infusion every three weeks. The other group will receive pembrolizumab with pemetrexed and either carboplatin or cisplatin, all administered by intravenous infusion every three weeks. Treatment schedules and dosages are carefully monitored during the study. Throughout the study, participants will be regularly assessed for progression-free survival and overall survival, with follow-up lasting up to approximately five years. Researchers will perform various evaluations including tumor measurements and safety monitoring. This long-term observation helps to understand the treatments' effects and safety over time, supporting informed decisions for future lung cancer therapies.

Researchers are evaluating the effectiveness of Saruparib (AZD5305) compared to placebo when added to a standard radiation therapy (RT) and androgen deprivation therapy (ADT) regimen in men with high-risk and very high-risk localized or locally advanced prostate cancer who have a BRCA gene mutation. This phase III study aims to assess whether Saruparib can improve metastasis-free survival in this population. About 700 adult male participants will be randomly assigned to receive either Saruparib or placebo along with ADT. There are two groups: Cohort A includes 400 participants with newly diagnosed high-risk or very high-risk prostate cancer treated with primary RT or with high-risk biochemical recurrence after radical prostatectomy receiving salvage RT. Cohort B includes 300 participants with very high-risk locally advanced prostate cancer receiving primary RT combined with ADT and abiraterone. Saruparib and placebo will be given orally, and standard ADT and abiraterone with prednisone/prednisolone will be administered as per the regimen. Participants will be followed for up to about 93 months to monitor metastasis-free survival and overall safety. Assessments include imaging scans like CT, MRI, bone scans, and PSMA-PET to confirm disease status. The study also monitors organ function, performance status, and treatment adherence. An independent committee will review safety and efficacy data throughout the trial to ensure participant well-being and study integrity.

Researchers are comparing the effectiveness of two treatments for participants with stage IV or recurrent non-squamous non-small cell lung cancer (NSCLC) who have PD-L1 expression of 1% or higher. This phase 3, randomized, open-label study focuses on first-line treatment options and aims to evaluate overall survival over up to five years for participants with PD-L1 levels between 1% and 49%. The trial involves participants with measurable disease and good performance status who have not received prior systemic therapy for advanced disease. The study compares a combination of Nivolumab and Relatlimab plus chemotherapy against Pembrolizumab plus chemotherapy. Chemotherapy drugs include Carboplatin, Pemetrexed, and Cisplatin, administered at specified doses on scheduled days. Participants are randomly assigned to receive either the Nivolumab and Relatlimab combination with chemotherapy or Pembrolizumab with chemotherapy as their initial treatment. Treatment schedules and doses are defined but not detailed here. Participants will be closely monitored throughout the study, which may last up to five years. Researchers will assess overall survival as the primary outcome, along with regular imaging tests like CT or MRI to measure disease status. Eligibility screening includes assessing PD-L1 levels, performance status, and other health factors. Safety monitoring and follow-up will continue to evaluate treatment effects and participant well-being during and after treatment.

Researchers are comparing the length of time participants survive without signs of cancer returning after treatment for high-risk non-muscle-invasive bladder cancer (HR-NMIBC). This Phase 3 study focuses on patients who have received Bacillus Calmette-Guérin (BCG) treatment and have specific FGFR mutations or fusions. The study aims to evaluate and compare disease-free survival between those treated with TAR-210 and those receiving intravesical chemotherapy chosen by the investigator. Participants will receive either TAR-210, a drug administered directly into the bladder, or one of two chemotherapy drugs, Mitomycin C or Gemcitabine, also given intravesically. All visible tumors must be fully removed before randomization. The study includes patients who are either unresponsive to BCG, experienced with BCG, or intolerant to BCG treatment. Participants must not be eligible for or must refuse radical cystectomy surgery. During the study, participants will be monitored for disease-free survival for up to five years. Researchers will perform assessments including urine testing, tumor tissue analysis, and biopsies as needed to confirm eligibility and monitor disease status. Safety, treatment adherence, and patient health status will be regularly evaluated to ensure ongoing suitability for the study.

Researchers are evaluating the safety and effectiveness of combining JSB462 (luxdegalutamide) at doses of 100 mg and 300 mg once daily with abiraterone, compared to an androgen receptor pathway inhibitor (ARPI) such as abiraterone or enzalutamide in adult men with metastatic hormone-sensitive prostate cancer (mHSPC). This Phase II study aims to select the recommended dose of the combination for further Phase III trials by assessing overall efficacy, safety, tolerability, and pharmacokinetics in participants. Participants receive JSB462 orally every day at either 100 mg or 300 mg doses continuously from randomization until disease progression, unacceptable side effects, death, or decision to stop treatment. Alongside this, abiraterone (1000 mg daily) or enzalutamide (160 mg daily) is also given continuously under the same conditions. The study includes a 28-day screening period, followed by the treatment period and then a 30-day post-treatment safety follow-up. After this, a long-term follow-up phase collects ongoing safety, efficacy, and survival data until the study ends. Throughout the study, participants undergo monitoring for prostate specific antigen (PSA) response, adverse events, dose adjustments, and duration of treatment exposure. Safety visits occur 30 days after treatment stops, and long-term follow-up tracks participant health until study completion. The total participation duration varies depending on individual treatment response and follow-up schedules, with assessments continuing for up to approximately 75 months from randomization.

Researchers are investigating the safety and effectiveness of TYRA-300 in adults with low-grade, intermediate-risk non-muscle invasive bladder cancer (NMIBC) that has specific FGFR3 gene changes. This Phase 2, open-label, multicenter study focuses on participants whose tumors have FGFR3 mutations or fusions and who have residual visible bladder tumors after prior surgery. It aims to assess how well TYRA-300 works in this group at 3 months after treatment begins. Participants will self-administer oral TYRA-300 tablets daily, with doses of 50mg or 60mg or a dose to be determined. The study does not include a placebo or other comparator groups. Treatment continues while participants are monitored for response and safety. The study includes careful eligibility screening to ensure participants meet specific tumor and health criteria, including no recent bladder cancer treatments or certain infections. During the study, participants will undergo regular evaluations including laboratory tests, imaging, and clinical assessments to monitor tumor response and safety. Researchers will track treatment effects and adverse events throughout the study. Participants must be able to swallow tablets and commit to contraception requirements if of childbearing potential. The total duration and follow-up details are based on treatment and safety monitoring schedules defined by the study protocol.