Osteosarcoma

Researchers are evaluating a new PET imaging tracer called [18F]FAPI-74 to detect cancer by targeting the fibroblast-activation protein (FAP) found in cancer-associated fibroblasts. This study aims to compare [18F]FAPI-74 PET scans to the standard [18F]-FDG PET scans and other imaging methods like CT or MRI across several cancers including pancreatic ductal adenocarcinoma, cholangiocarcinoma, hepatocellular carcinoma, gastric, bladder, ovarian cancers, pheochromocytoma/paraganglioma, small cell lung cancer, neuroendocrine cancer, mesothelioma, and sarcoma. The study is a phase 2 interventional trial conducted by the National Cancer Institute (NCI). Participants will receive an intravenous dose of [18F]FAPI-74 before undergoing PET/CT imaging about one hour later. They will also have a baseline FDG PET scan within one week. If tumors are detected by [18F]FAPI-74, additional scans using this tracer and FDG may be repeated during routine treatment and if cancer progresses within two years. Those with negative baseline [18F]FAPI-74 scans will not have repeated scans but remain in follow-up. The study involves a single arm where participants undergo both types of PET imaging. During the study, participants will have scans at baseline and potentially at subsequent treatment or progression points. Safety monitoring includes observation for reactions to the tracer up to three days after injection. Researchers will measure the mean number of lesions, standardized uptake values at baseline, post-treatment, and recurrence. Follow-up calls will continue for two years to assess progression-free survival and overall survival. The total participation duration includes imaging visits and two years of follow-up monitoring.

Researchers are evaluating the imaging agent 64Cu-LNTH-1363S in patients with sarcomas or gastrointestinal tract (GIT) cancers to assess its safety, determine the best imaging dose and timing, and compare the imaging results with fibroblast activation protein (FAP) expression in tumor samples. This Phase 1/2a open-label study is divided into two parts and aims to better understand how this radiolabeled agent behaves in the body and how well it highlights tumors that express FAP. In Part 1, six patients with metastatic sarcomas will receive a fixed dose of 64Cu-LNTH-1363S to evaluate its distribution, radiation dose, and optimal imaging window during a one-day intervention, followed by a safety follow-up. In Part 2, approximately 20 patients with non-metastatic, operable sarcomas or GIT cancers scheduled for surgery will receive the optimal dose determined in Part 1 to study the correlation between imaging results and tissue FAP expression. Both parts include detailed cardiac monitoring to assess any changes in heart activity related to the agent. Participants will undergo screening before receiving the imaging agent, followed by serial PET/CT scans at multiple timepoints on the intervention day to measure biodistribution and image quality. Tissue samples collected during surgery will be analyzed to compare with imaging findings. Safety and tolerability will be monitored through follow-up visits, ECGs, and phone contact. The total study duration varies from about three weeks for Part 1 to up to 11 weeks for Part 2, including surgery and post-surgery sample collection.

Researchers are studying the use of the TRUMATCH Graft Cage to repair large segmental defects in long bones such as the humerus, femur, and tibia. This observational case series includes patients aged 18 and older who have these critical-sized bone defects requiring surgical fixation. The goal is to collect data over three years to better understand the healing process, complications, and recovery outcomes associated with this device. Participants who agree to join will receive the TRUMATCH Graft Cage during surgery to repair their long bone defects. The study focuses on collecting information about healing rates, complication rates, reoperation rates, pain levels, and the time it takes to return to normal activities. Data collection will occur over two years following the procedure to evaluate early outcomes of using the graft cage. During the study, participants will be monitored regularly to track their healing progress and any complications. Researchers will assess pain scores, need for additional surgeries, and functional recovery. The study will analyze this information after three years of data collection to provide insights on the graft cage's usefulness for managing complex long bone injuries. Participation involves follow-up visits and evaluations related to their surgical repair and recovery.

Researchers are studying the safety and initial effects of T3011, given directly into tumors, alone and combined with the intravenous drug pembrolizumab. This Phase 1/2a open-label study focuses on adults with advanced or metastatic solid tumors, including melanoma, head and neck squamous cell carcinoma (HNSCC), sarcoma, cutaneous squamous cell carcinoma (cSCC), and non-small cell lung cancer (NSCLC). The study aims to find safe dose levels and assess how well these treatments are tolerated and work in these cancer types. The study involves several groups: Phase 1 tests increasing doses of T3011 alone to determine a recommended dose. Phase 2a Part 1 evaluates T3011 alone in participants with melanoma, HNSCC, sarcoma, and cSCC. Phase 2a Part 2 studies T3011 with pembrolizumab in NSCLC patients. A rollover arm allows participants whose cancer progresses on T3011 alone to receive the combination treatment. T3011 is given as an intratumoral injection every two weeks, and pembrolizumab is given intravenously every three weeks when combined. Participants will have tumor biopsies, imaging, and laboratory tests to monitor safety, drug levels, and cancer response. Researchers will track side effects and measure outcomes like tumor response and survival for up to two years after the first dose. Safety and tolerability are closely followed throughout, with additional monitoring for immune responses and drug presence in bodily fluids. Participants may be followed for up to one year after their last treatment dose to assess overall survival and long-term effects.

Researchers are investigating the tumor necrosis rate in patients with osteosarcoma treated with a neoadjuvant regimen combining surufatinib and chemotherapy. This phase II, prospective, multicenter, controlled study aims to assess the efficacy and safety of surufatinib, a drug that inhibits colony-stimulating factor 1 receptor, which may have tumor-inhibiting effects on sarcoma. The study includes 160 participants divided into two groups to compare surufatinib plus chemotherapy versus chemotherapy alone. Participants in the study receive treatment cycles lasting 30 days. One group receives surufatinib combined with chemotherapy, while the other receives chemotherapy only. The surufatinib dose varies by age and body surface area, with specific chemotherapy drugs administered in a set schedule over the cycle. After two cycles of neoadjuvant therapy, the tumor necrosis rate is evaluated to measure treatment impact. During the study, participants undergo evaluations including tumor assessments, blood tests, and monitoring for adverse events. The primary outcome is the tumor cell necrosis rate after 12 months. Secondary outcomes include progression-free survival at one year and safety assessments over 24 months according to standard criteria. Participants are monitored for organ function, tumor response, and treatment side effects throughout the treatment and follow-up periods.

Researchers are evaluating the safety and effectiveness of a modified herpes simplex virus called recombinant oncolytic herpes simplex virus type 1 (R130) in patients with advanced solid tumors. This early phase 1, open, single-arm clinical trial aims to study the treatment in people with various cancers such as sarcoma, carcinoma, digestive cancer, breast cancer, lung cancer, brain cancer, melanoma, gynecologic cancer, head and neck cancer, and kidney cancer. The study focuses on patients who have not responded to standard treatments or who choose not to receive other antitumor therapies. Participants will receive injections of 1 to 2 milliliters of R130 at a concentration of 1x10^8 plaque-forming units per milliliter into their tumors or abdominal cavity every 7 to 14 days. This approach allows the virus to be delivered directly to the cancer site. The study involves only one treatment group receiving the R130 virus, and no placebo or comparison group is used. During the trial, researchers will monitor participants for adverse events and laboratory abnormalities up to 6 months and assess their immune response. Disease control and response duration will be evaluated every 10 weeks for up to 12 months, while quality of life assessments will occur every 6 weeks for the same period. Participants will undergo regular laboratory tests and clinical evaluations to track safety and treatment impact. The total study duration for each participant may extend up to one year with ongoing monitoring.

Researchers are studying the safety and effectiveness of a modified herpes simplex virus called R130 for treating advanced bone and soft tissue tumors, including osteosarcoma and sarcoma. This early-phase, open-label clinical trial aims to learn how this oncolytic virus works in patients who have relapsed or refractory tumors and have not responded to standard treatments or choose not to receive other therapies. Participants will receive injections of 1 to 2 ml of R130, containing 1x10^8 plaque-forming units per milliliter, directly into their tumors every 7 to 14 days. The treatment focuses on patients with measurable lesions suitable for direct injection. This single-arm study does not include a comparison group and is sponsored by Shanghai Yunying Medical Technology. During the study, patients will be closely monitored for adverse events and laboratory changes up to 6 months after treatment. Researchers will assess immune responses, disease control, duration of response, and quality of life over a 12-month period with scheduled evaluations every 6 to 10 weeks. Participants must meet certain health and organ function requirements and will be followed for safety and outcomes throughout the trial.

Researchers are investigating the study drug OKN4395 alone and in combination with pembrolizumab in patients with advanced solid tumors. The study aims to assess the safety, tolerability, blood levels of OKN4395 and its metabolites, and the antitumor activity of these treatments. This phase 1 study focuses on patients whose tumors involve a COX2-associated immunosuppressive pathway and includes various cancer types such as sarcoma, pancreatic adenocarcinoma, non-small cell lung cancer, colorectal cancer, and head and neck squamous cell carcinoma. The study consists of two parts. Part 1a involves dose escalation of OKN4395 alone or with pembrolizumab given on day 1 of each 21-day cycle to determine the optimal dose, with doses ranging from 10 mg twice daily up to 450 mg twice daily. Part 1b includes five cohorts with specific cancer types receiving OKN4395 alone or combined with pembrolizumab to evaluate treatment effects and explore factors like food and gastric pH on OKN4395 blood levels. Participants continue treatment until disease progression or for other reasons. Participants will undergo safety and response assessments including monitoring of dose-limiting toxicities, treatment-emergent adverse events, laboratory tests, ECGs, and vital signs over up to 27 months in Part 1a and up to 12 months in Part 1b. Researchers will also evaluate overall response rates, disease control, progression-free survival, and pharmacokinetics of OKN4395. The study involves multiple visits for treatment and evaluations, with careful observation of side effects and tumor responses throughout the trial period.

Researchers are evaluating the safety and anti-tumor activity of OMO-103, a Myc inhibitor, in patients with advanced high-grade osteosarcoma. This phase 2 pilot study aims to provide proof-of-concept data on the drug's effects and tolerability. The study includes patients aged 12 years and older with disease progression after standard chemotherapy. Participants receive OMO-103 intravenously at a dose of 6.5 mg/kg once weekly in 28-day cycles. Treatment continues until the cancer progresses or intolerable side effects occur. Additional safety monitoring will be conducted for patients aged 12 to 15 years. The study plans to enroll ten evaluable patients, with at least 30% under 18 years of age. During the study, patients undergo tumor biopsies, imaging scans, and assessments to measure tumor response and drug pharmacokinetics. Quality of life and safety are monitored throughout treatment, with evaluations continuing up to 24 months or until withdrawal. The primary outcome is the anti-tumor activity after 16 weeks of treatment, with ongoing follow-up for safety, tolerability, and treatment effects.

Researchers are conducting an open, single-arm Phase I clinical trial to evaluate the safety, tolerability, viral distribution, shedding patterns, pharmacodynamics, immunogenicity, and initial antitumor effects of the GC001 oncolytic vaccinia virus injection in patients with advanced solid tumors. The study aims to identify dose-limiting toxicities, maximum tolerated dose, or maximum administered dose of the treatment in this population. This trial includes patients with various advanced solid tumors for which standard treatments are ineffective or unavailable. The study involves a dose escalation design with up to six dose groups ranging from 3 x 10^6 to 1 x 10^9 plaque-forming units (PFU). Each participant receives a single intratumoral injection of GC001, up to 4 mL based on lesion size, targeting up to two measurable extracranial lesions. A Safety Monitoring Committee oversees dose escalation decisions based on safety, tolerability, and preliminary efficacy data. The study carefully monitors viral biodistribution, shedding, pharmacodynamics, and immune responses alongside antitumor activity. Participants will be observed closely for 28 days post-injection to assess safety and dose-limiting toxicities. Follow-up includes evaluations of tumor response, duration of response, and progression-free survival for up to two years. Assessments include imaging scans, viral monitoring, and immunologic tests. The study also includes ongoing safety monitoring, with adjustments to dosing, administration schedules, and biospecimen collection times as needed. Total participation duration varies based on individual follow-up requirements.