Chondrosarcoma

Researchers are evaluating a new PET imaging tracer called 18FFAPI-74 to detect cancer by targeting the fibroblast-activation protein FAP found in cancer-associated fibroblasts. This study aims to compare 18FFAPI-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, pheochromocytomaparaganglioma, 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 18FFAPI-74 before undergoing PETCT imaging about one hour later. They will also have a baseline FDG PET scan within one week. If tumors are detected by 18FFAPI-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 18FFAPI-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 12a 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 PETCT 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 safety and initial effects of T3011, given directly into tumors, alone and combined with the intravenous drug pembrolizumab. This Phase 12a 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 drug OKN4395, alone and combined with pembrolizumab, in adults with advanced solid tumors. This Phase 1 study aims to assess the safety, tolerability, blood levels, and anti-tumor activity of OKN4395 both as a single treatment and alongside pembrolizumab. The study focuses on tumors with a COX2-associated immunosuppressive pathway and includes multiple cancer types such as sarcoma, non-small cell lung cancer, colorectal cancer, and gastric cancer. The study is divided into two main parts. Part 1a includes dose escalation of OKN4395 alone or with pembrolizumab every 21 days, increasing doses based on safety evaluations, and a substudy testing how food and stomach acid affect OKN4395 blood levels. Part 1b evaluates OKN4395 alone or combined with pembrolizumab in four cancer cohorts. Participants receive oral OKN4395 twice daily, with pembrolizumab given intravenously every three weeks where applicable. The substudy involves dosing under fasting, fed, and high stomach pH conditions using famotidine. Participants will be monitored through regular visits lasting up to 27 months for Part 1a and up to 12 months for Part 1b. Assessments include safety checks for side effects, blood tests for drug levels and lab abnormalities, ECGs, tumor measurements, and evaluation of treatment response and progression. The study tracks dose adjustments, adverse events, and survival outcomes to understand the drugs effects and tolerability in solid tumor patients.

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 106 to 1 x 109 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.

Researchers are evaluating a new medicine called Risvutatug Rezetecan Ris-Rez for adolescents and adults with certain cancers, specifically osteosarcoma a type of bone cancer and soft tissue sarcoma cancer in soft tissues like muscle, fat, or nerves. These cancers must have been previously treated but have returned or spread and cannot be removed by surgery. The study aims to assess the safety, tolerability, and how the body processes this medicine. Participants will receive Ris-Rez in one of three groups receiving Ris-Rez alone, Ris-Rez combined with Granulocyte-Colony Stimulating Factor G-CSF, or Ris-Rez alone in a separate cohort. The study is randomized and involves monitoring how well participants tolerate the medicine and how it affects their cancer. Dosage, administration details, and schedules are managed per the study protocol over an extended period. During the study, participants will undergo various assessments including monitoring of disease progression, adverse events, vital signs, body weight, laboratory tests such as blood counts and chemistry, heart function via electrocardiogram, and performance status. Researchers will also measure responses to treatment and collect data on drug levels and immune reactions. Participant experiences with the study treatment are recorded. The study includes long-term follow-up for safety and effectiveness over several weeks, with some outcome measures tracked up to approximately 179 weeks.

Researchers are studying cabozantinib as a maintenance treatment to prevent progression or recurrence in children and young adults with ultra-high-risk pediatric solid tumors. These tumors include neuroblastoma, Ewing sarcoma, osteosarcoma, rhabdomyosarcoma, Wilms tumor, and other rare tumors that express targets of cabozantinib or show preclinical evidence of response. The study aims to improve progression-free survival and overall survival while maintaining quality of life in patients who have achieved their best response to prior therapy. Participants will receive cabozantinib tablets at a dose of 40 mgm2 per day, up to a maximum of 420 mg per week, given in 28-day cycles for up to one year. This approach targets the critical period within 12 months after last therapy when recurrence risk is highest. The study expands current research by evaluating cabozantinib in a wider range of pediatric solid tumors and testing its use as a maintenance therapy during remission to potentially extend disease control. Throughout the study, patients will be monitored for progression-free survival at one year as the primary outcome, with additional assessments of overall survival, duration of response, and safety over several years. Participants must meet strict eligibility criteria including age, performance status, organ function, and recovery from prior treatments. The study involves regular clinical evaluations, laboratory tests, imaging, and assessment of adverse events to ensure safety and measure treatment effects over time.

Researchers are evaluating the safety and effects of a study drug called CRD3874-SI in adults with advanced or metastatic malignant solid tumors, including types such as sarcoma, Merkel Cell Carcinoma, head and neck squamous cell carcinoma, adenoid cystic carcinoma, uveal melanoma, mucosal and acral melanoma, and non-small cell lung cancer. The study aims to find the highest dose of CRD3874-SI that causes only mild or manageable side effects and to learn more about how the drug is processed by the body and how the immune system responds to it. Participants receive weekly intravenous infusions of CRD3874-SI starting at a dose of 0.1 mgkg, with dose levels increasing in phases to find the recommended dose for further study. The treatment cycles vary, with the first two cycles consisting of four weekly infusions each over 28 days, and later cycles providing three weekly infusions if the treatment is well tolerated. The trial also includes a dose expansion phase where the recommended dose and one additional active dose are tested in selected tumor types. Blood tests and tumor biopsies are performed during the study to help assess the drugs effects. During the trial, participants undergo regular evaluations including tumor biopsies when feasible, blood tests for immune cells, and assessments of tumor response. Safety is closely monitored through side effect tracking and organ function tests. The studys main outcomes include determining the maximum tolerated dose over one year and measuring tumor response rates during dose expansion up to 48 weeks. Participation may last several months depending on treatment tolerance and disease progression, with ongoing monitoring to understand the drugs safety and activity.

Researchers are studying MGC026, a drug designed to target advanced solid tumors that are relapsed, refractory, unresectable, locally advanced, or metastatic. This Phase 11b study aims to evaluate the safety, tolerability, how the body processes the drug, immune response, and preliminary antitumor effects. The study includes a dose escalation phase followed by a cohort expansion phase to better understand MGC026s effects in different groups of patients. Participants will receive MGC026 through intravenous infusion every three weeks. The dose will be assigned at enrollment. They may continue treatment for up to 35 cycles as long as there are no severe side effects and the cancer does not worsen. The drug is a topoisomerase 1 inhibitor-based antibody-drug conjugate targeting B7-H3. The study monitors participants for side effects, cancer progression, and collects blood samples for routine lab testing and research. During the study, participants will have regular monitoring for adverse events and cancer status over a period of up to 135 weeks. Blood samples will be taken at scheduled times for pharmacokinetic and immunogenicity analyses. Researchers will assess the number and severity of side effects, response rates, duration of response, and development of antibodies against MGC026. Participants health and safety will be closely observed throughout the trial period.

Researchers are evaluating pembrolizumab as a treatment option for people with ultra-rare sarcomas, a group of uncommon cancers. The study aims to find out if pembrolizumab is effective and causes only mild or few side effects. It also investigates how the immune system responds to this drug, which works by blocking a protein called PD-1 to help the immune system target cancer cells. Participants will receive pembrolizumab through an intravenous infusion every 6 weeks, up to 8 doses. The study includes different sarcoma types such as pleomorphic liposarcoma, PEComa, epithelioid sarcoma, CIC-rearranged sarcoma, and sclerosing epithelioid fibrosarcoma. Treatment will continue for about 48 weeks or fewer based on dosing schedule. During the study, participants will be monitored for treatment response at 12 weeks and assessed for side effects over 2 years. Researchers will collect medical information and tumor details, and participants will undergo regular evaluations to track health status and immune response. The total participation may last up to 2 years with ongoing safety assessments.