Skorzewo

Researchers are studying advanced renal cell carcinoma (RCC) that has returned after prior adjuvant therapy. The trial aims to find out if treatment with belzutifan and zanzalintinib helps patients live longer and delays disease progression compared to treatment with cabozantinib. This is a Phase 3 randomized study focusing on participants with recurrent advanced RCC who have previously received anti-PD-1/L1 therapy. Participants are randomly assigned to receive one of two oral drug regimens: either belzutifan combined with zanzalintinib, both taken once daily, or cabozantinib alone, also taken once daily. The study compares these treatments to assess their effects on disease control and overall survival. During the study, participants will be monitored for progression-free survival and overall survival for up to approximately 73 months. Researchers will evaluate how well the cancer responds to treatment and track any changes in health status over time. Safety and effectiveness of the treatments will be closely followed throughout the study period.

Researchers are evaluating the effect of vipoglanstat on reducing non-menstrual pelvic pain related to endometriosis in women. This phase 2 trial focuses on women who have moderate to severe pain caused by endometriosis, aiming to see how well vipoglanstat works compared to a placebo. The study is designed to measure changes in pain over a period of about four months. Participants in this trial will receive either vipoglanstat capsules or matching placebo capsules taken orally for approximately four menstrual cycles during the treatment period. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the active drug or placebo until the study ends. Two different doses of vipoglanstat are being tested to assess safety and effectiveness. During the study, women will be monitored for changes in their endometriosis-related non-menstrual pelvic pain, with the primary measure being the percentage of participants who meet a specific pain response criterion from the start of the study to the fourth month of treatment. The trial includes careful tracking of symptoms and safety over the treatment duration to evaluate how well vipoglanstat manages pain in this population.

Researchers are evaluating the safety and effectiveness of HLX22 combined with trastuzumab and chemotherapy as the first treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 2, double-blind, randomized, and multiregional study compares this combination against trastuzumab and chemotherapy with or without pembrolizumab. The study aims to measure how well the treatments work in controlling the disease and improving survival for up to five years. Participants will be randomly assigned to one of two groups. One group receives HLX22 at 15 mg/kg every three weeks along with trastuzumab, chemotherapy (XELOX regimen), and possibly a placebo for pembrolizumab. The other group receives a placebo for HLX22 plus trastuzumab, chemotherapy (XELOX), and possibly pembrolizumab every three weeks. Treatment continues until the disease worsens, unacceptable side effects occur, withdrawal of consent, or other protocol-specified reasons. Throughout the study, participants will undergo regular assessments including tumor scans reviewed by an independent committee to evaluate progression-free survival and overall survival over up to five years. Other evaluations include safety monitoring and organ function tests. The study tracks how long patients live without disease progression and overall survival, aiming to better understand the benefits and risks of HLX22 combined with current standard treatments.

Researchers are evaluating the effectiveness and safety of pirtobrutinib in adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study focuses on two parts: Part 1 tests three different doses of pirtobrutinib in participants who have had 1 to 3 prior treatments, including a covalent Bruton tyrosine kinase (BTK) inhibitor. Part 2 evaluates pirtobrutinib alone in participants who have not received prior treatment but have a specific genetic deletion called 17p. This is a phase 2, open-label, randomized study. Pirtobrutinib is given orally to participants in both study parts. Participants in Part 1 receive one of three dose levels, while those in Part 2 receive pirtobrutinib monotherapy. Part 1 participation lasts about 3 years, and Part 2 participation can last up to 2 years. The study compares the effects of different doses and treatment histories to better understand pirtobrutinib’s impact on CLL/SLL. Throughout the study, researchers monitor participants' overall response to treatment from the start up to 3 years. They assess safety and side effects, and participants are required to be able to swallow oral medication and have a performance status that allows them to participate. The study includes regular evaluations to determine how well the treatment controls the disease and to track any adverse events over the course of the study periods.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Multiple myeloma is a cancer affecting plasma cells in the bone marrow. Researchers are evaluating how well Immune Globulin Infusion (human), 10% (IGI, 10%) can help prevent infections in adults with multiple myeloma receiving B-cell maturation antigen (BCMA) x CD3-directed bispecific antibody therapy. This phase 3 study aims to compare primary infection prevention using IGI, 10% versus secondary infection prevention in this patient group. Participants will be randomly assigned to one of two groups: the primary infection prevention group will receive IGI, 10% infusions for 12 months, while the secondary infection prevention group will receive IGI, 10% only if they develop a serious infection during the 12-month study period. The IGI, 10% is given intravenously. The study includes a screening period of up to 8 weeks, followed by treatment and monitoring. During the study, participants will attend 15 clinic visits if on a 4-week dosing schedule or 19 visits if on a 3-week dosing schedule, with total participation lasting up to 14 months. Researchers will monitor the time to first serious infection over 12 months. Participants will undergo evaluations to assess infection status and treatment safety throughout the study.

This research aims to evaluate the safety and effectiveness of iza-bren, a bi-specific antibody-drug conjugate targeting EGFR and HER3 with a topoisomerase inhibitor, compared to the treatment of physician's choice (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, or capecitabine). The study focuses on patients with previously untreated, locally advanced, recurrent inoperable, or metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, HER2-negative breast cancer who are not eligible for anti-PD(L)1 or endocrine therapies. The trial is conducted in two phases, phase 2 and phase 3, to thoroughly assess these treatments.

Researchers are evaluating the safety, effectiveness, and how the body processes LY4584180 in adults with previously treated blood cancers such as non-Hodgkin's lymphoma, diffuse large B-cell lymphoma, and follicular lymphoma. This phase 1a/1b, first-in-human study focuses on patients who have undergone at least two prior treatments or who are not eligible for available therapies. The goal is to understand the drug's impact and how well it works in this population. Participants receive LY4584180 orally, and some may also be given rituximab through intravenous infusion. The study tracks the number of toxicities related to the drug during the first 28 days and continues to monitor serious side effects related to the treatment for up to three years. The treatment period includes measuring the drug's pharmacokinetics, safety, tolerability, and preliminary antitumor activity. Throughout the study, participants undergo regular evaluations including safety assessments, disease measurements, and monitoring for adverse events. Researchers assess the objective response rate to determine how the disease responds to the treatment. The overall participation time can last about 9 months or longer, including initial screening and follow-up visits to ensure safety and efficacy over time.

Researchers are evaluating NX-5948, a treatment for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously been treated with both a Bruton's Tyrosine Kinase inhibitor (BTKi) and a B-cell Lymphoma-2 inhibitor (BCL-2i). NX-5948 works by destroying the BTK protein, which differs from BTK inhibitors that only block part of its action. This phase 2, open-label study aims to assess how well NX-5948 works, its safety, and how long patients can take it. All participants will receive NX-5948 orally once daily in continuous 28-day cycles until their cancer worsens or other reasons require stopping treatment. During treatment, patients will have regular cancer and health check-ups. If treatment stops without cancer progression, monitoring will continue until disease worsening occurs. Participation in the study could last up to five years or longer if the disease remains stable. Throughout the study, researchers will regularly evaluate patients' cancer status and overall health. They will monitor the response to NX-5948, including the objective response rate without partial response with lymphocytosis, as assessed by an independent committee for up to approximately five years. Safety and drug levels in the bloodstream will also be tracked, ensuring comprehensive long-term monitoring of patients in the trial.

Researchers are evaluating the safety and anti-cancer activity of NX-5948, an oral Bruton's Tyrosine Kinase (BTK) degrader, in adults with advanced B-cell malignancies. This Phase 1a/1b open-label study focuses on patients with relapsed or refractory B-cell cancers who have received prior therapies and for whom no other beneficial treatments are known. The study includes multiple types of B-cell cancers such as Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Diffuse Large B-cell Lymphoma (DLBCL), Mantle Cell Lymphoma (MCL), and others, including those with central nervous system involvement. In Phase 1a, the study escalates doses of NX-5948 to assess its safety and tolerability in patients with various B-cell malignancies who have specific prior treatment histories. Phase 1b Part 1 expands safety and evaluates anti-tumor activity at selected doses across up to 17 patient groups with different B-cell cancers. Part 2 further explores anti-tumor effects in an additional group of CLL/SLL patients at the selected dose. Treatment involves oral administration of NX-5948, with patients possibly randomized to different dose levels to find the optimal dosing. Participants will undergo regular assessments including monitoring for side effects, tumor response evaluations through clinical and laboratory tests, and tracking of adverse events over months to years. Key measures include dose-limiting toxicities, overall response rates, and safety outcomes such as serious adverse events and treatment discontinuations. The study aims to establish maximum tolerated doses and long-term safety while observing the drug's activity against B-cell cancers over up to six years of follow-up.