Otwock

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 how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

Researchers are evaluating Risvutatug rezetecan (Ris-Rez), a new medicine that targets specific proteins called B7-H3 on cancer cells to reduce the cancer's ability to grow and spread. This study focuses on participants with relapsed extensive-stage small cell lung cancer (ES-SCLC) who have previously received platinum-based systemic therapy combined with a PD-(L)1 inhibitor. The trial aims to compare how well Ris-Rez works versus the standard treatment topotecan in shrinking tumors or making them disappear, and whether Ris-Rez helps participants live longer. The study also assesses the safety and tolerability of Ris-Rez compared to topotecan and gathers information on side effects of both treatments. Participants will be randomly assigned to receive either Ris-Rez, administered as a biological treatment, or topotecan, given as a drug treatment. The study is a phase 3, multicenter, randomized, open-label clinical trial. Both treatments will be provided according to the study protocol, and participants will be monitored carefully throughout the treatment period. During the study, participants will undergo assessments to monitor tumor response using RECIST 1.1 criteria and overall survival for up to approximately 113 weeks. Researchers will also evaluate participants' organ function, performance status, and side effects. Safety monitoring includes checking for cardiovascular health, infections, bleeding, and lung conditions. The study requires participants to provide informed consent and comply with study procedures and restrictions throughout their involvement.

Researchers are evaluating the safety and effectiveness of Ifinatamab Deruxtecan (I-DXd) compared to treatment chosen by physicians for adults with relapsed extensive-stage small cell lung cancer (ES-SCLC). The study aims to find out if I-DXd can improve the objective response rate, meaning the proportion of patients whose cancer shrinks or disappears, and extend overall survival time compared to other treatments. Secondary goals include assessing safety, patient-reported outcomes, immune response to I-DXd, B7-H3 protein levels, and how the drug is processed in the body. Participants will receive either I-DXd at a dose of 12 mg/kg given intravenously on the first day of each 21-day treatment cycle or one of the physician's choice treatments including Topotecan, Amrubicin, or Lurbinectedin, administered according to local standards of care. The study is randomized and open-label, meaning treatments are assigned by chance and both patients and doctors know which treatment is given. During the study, participants will be closely monitored with tumor assessments to evaluate response and detect disease progression, safety evaluations, and quality of life questionnaires. The main outcomes measured are the objective response rate assessed by a blinded independent review and overall survival time, tracked for up to approximately five years after randomization. Researchers will also monitor for any adverse effects and collect health economics data to understand the broader impact of treatments.

Researchers are conducting a phase 1, multicenter, nonrandomized, open-label, first-in-human study to evaluate YL201 in patients with advanced solid tumors. The study is taking place in China and the United States and consists of two parts: a dose escalation phase to determine the maximum tolerated dose and recommended dose, followed by a dose expansion phase to further assess safety and efficacy. This study targets patients whose tumors are unresponsive to current therapies or who have no standard treatment options available. Participants will receive YL201 through intravenous infusion once every three weeks as a treatment cycle. In some groups, YL201 is administered alone, while in others it is combined with atezolizumab on the first day of each 21-day cycle. The dose escalation phase involves careful monitoring to identify dose-limiting toxicities. The dose expansion phase will enroll patients at the established dose to better define safety and evaluate responses, including in prostate cancer and other solid tumors. Throughout the study, participants will undergo regular assessments including laboratory tests, evaluation of tumor response using RECIST criteria, and monitoring of adverse events. Researchers will track the occurrence of dose-limiting toxicities during the first treatment cycle and overall safety up to approximately 36 months. They will also measure prostate-specific antigen response rates in prostate cancer patients and objective response rates in other solid tumors. Participants must comply with scheduled visits and procedures during the study period.

Researchers are investigating better treatments for people with advanced non-small cell lung cancer (NSCLC) that has specific genetic changes called HER2 mutations. Advanced NSCLC refers to lung cancers that have spread or are unlikely to be controlled with current treatments. HER2 is a protein that helps cells grow, and mutations cause abnormal HER2 leading to cancer growth. This Phase 3 study aims to compare the safety and effectiveness of a new drug, sevabertinib, against standard treatment in patients with this type of lung cancer. Participants will be randomly assigned to receive either sevabertinib tablets twice daily by mouth or standard treatment consisting of cycles of intravenous infusions including drugs like pembrolizumab, cisplatin, carboplatin, and pemetrexed every 21 days. Treatments continue as long as participants benefit without severe side effects or until they or their doctors decide to stop. Participants on standard treatment whose disease worsens may switch to sevabertinib and continue until progression, intolerable side effects, or decision to stop. During the study, participants will undergo imaging scans such as CT, PET, MRI, and X-rays to monitor cancer spread. Health checks include blood and urine tests, heart monitoring with ECG, and pregnancy tests for women. Researchers will ask about participants’ well-being and record any medical problems or side effects experienced. The main outcome measured is progression-free survival over up to about two years.

Researchers are evaluating the safety and potential anti-cancer activity of OATD-02, given orally as a single treatment, in people with advanced or metastatic colorectal, ovarian, renal, or pancreatic cancers. This early-phase (Phase I) trial aims to see if OATD-02 can safely increase arginine levels or directly fight tumors in these patients who have already tried standard treatments. Participants will receive OATD-02 starting at a dose of 2.5 mg once daily, with dose levels adjusted using a Modified Bayesian Optimal Interval design based on the occurrence of dose-limiting toxicities. The treatment period can last up to 6 months. The study plans to enroll 30 patients, with additional replacements if some patients' toxicity data cannot be evaluated. During the study, participants will be closely monitored for side effects and any signs of tumor response. Researchers will assess the frequency and severity of adverse events and track dose-limiting toxicities over 6 months. Patients will need to meet certain health and cancer criteria to join, and they will provide informed consent before starting. This study will help determine the safety and potential benefits of OATD-02 in these advanced cancers.

Researchers are evaluating the effectiveness, safety, and long-term outcomes of a biocomposite implant called FlexiOss4 for bone regeneration in patients with primary acute trauma bone defects. This study compares FlexiOss4 to the current standard care, which involves allogenic human bone grafting, to see how well each treatment supports bone healing and patient recovery. The study follows patients over a period of 24 months to assess both clinical and radiological results. Participants receive treatment with either the FlexiOss4 biocomposite implant or implantation of allogenic human bone graft during an orthopedic procedure for bone defects in the lower extremity or foot. The study includes follow-up visits scheduled at 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months to monitor progress. The intervention focuses on bone reconstruction using these two different materials to evaluate their comparative effectiveness. During the study, participants undergo regular assessments including clinical evaluations, radiological imaging, and questionnaires to measure load-bearing capacity, lower extremity function, and quality of life. Researchers track adverse events and serious adverse events throughout the 24-month period. The study requires participants to attend all follow-up visits to monitor their recovery and the long-term safety and efficacy of the implanted materials.

This is an observational study designed to reflect real life clinical practice as closely as possible. Thus, clinicians are free to choose the method to implant and total hip arthroplasty in accordance with the current local Delta Revision acetabular cup Indication for Use and current clinical practice.

This research aims to evaluate the impact of two different types of stabilization, stem versus sleeve, in the second stage of knee reimplantation surgery for patients who have a knee infection after primary knee replacement due to osteoarthritis. The study is prospective and randomized, focusing on whether the mechanical stability provided by sleeves can better support infection treatment compared to stems. Participants must meet specific infection criteria and will have undergone a two-stage treatment protocol for their knee infection. All participants first undergo a two-stage protocol involving debridement and spacer implantation, followed by 6 weeks of antibiotic treatment. When no signs of reinfection are present, the second stage of surgery is performed, where patients are randomly assigned to receive a revision knee endoprosthesis stabilized either with a stem or with a sleeve. After surgery, all patients receive targeted antibiotics for 3 weeks. The study compares these two stabilization methods. Participants will be evaluated before surgery and during periodic follow-ups using the Knee Society Score, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Visual Analogue Scale for pain. Their clinical condition, laboratory markers, and signs of reinfection will be monitored over a 2-year period to assess reinfection rates. The study collects detailed clinical and laboratory data to support its findings on treatment outcomes.