Metastatic Cancer

This trial studies neuroendocrine tumors, paraganglioma, pheochromocytoma, and other SSTR-positive tumors that are not currently approved for lutetium therapy called LUTATHERA. It aims to evaluate the effectiveness and safety of a similar treatment called lutetium (177Lu) edotreotide or 177Lu-DOTATOC in patients who have these diseases but are outside the standard indications for LUTATHERA. The study focuses on expanding knowledge about this therapy's role in controlling disease and managing side effects. Participants receive treatment with 177Lu-DOTATOC given by slow intravenous infusion over 30 minutes using a pump system. The dose depends on patient risk factors: those with fewer than two risk factors receive 7.4 GBq per cycle, while those with two or more risk factors receive 5.5 GBq per cycle. Each participant will receive 4 cycles of treatment. Risk factors include kidney impairment, previous toxicities, uncontrolled diabetes or hypertension, prior therapies, and disease burden. During the study, participants will have regular assessments over several months, including scans to measure disease control at 32 months and ongoing monitoring up to 44 months for progression-free survival, overall survival, safety, and quality of life. Researchers will check blood tests, organ function, and side effects. This non-randomized phase 2 study allows patients with measurable or evaluable disease and progressive tumors confirmed by imaging to be included, with follow-up to evaluate response and safety.

Researchers are evaluating the efficacy and safety of Thymalfasin combined with targeted immunotherapy drugs Regorafenib and Tislelizumab compared to Regorafenib and Tislelizumab alone in patients with advanced mismatch repair-proficient (pMMR) or microsatellite stable (MSS) colorectal cancer who have not responded to standard treatments. This Phase II randomized controlled study aims to compare progression-free survival between these two treatment approaches. The study will enroll 52 subjects across multiple centers with specific statistical assumptions guiding enrollment and analysis. Participants will be randomly assigned to one of two groups: a triple therapy group receiving Thymalfasin subcutaneously twice weekly along with oral Regorafenib and intravenous Tislelizumab, or a double therapy group receiving only Regorafenib and Tislelizumab. Regorafenib will start at 80 mg orally daily for two weeks followed by a one-week break, with an increase to 120 mg daily if tolerated. Tislelizumab is given by intravenous infusion once every 21 days. Treatment continues until disease progression according to iRECIST criteria or unacceptable side effects occur. During the study, participants will be monitored for disease progression and adverse events with regular assessments including imaging to measure tumor response. The primary outcome is progression-free survival at 48 weeks. Secondary outcomes include 18-week progression-free survival rate, objective response rate, disease control rate, and overall survival up to three years. Safety and tolerability will also be assessed throughout the trial. The total study duration includes enrollment over 9 months and follow-up for up to 15 months.

Researchers are evaluating the safety of a radiation therapy method called image-guided stereotactic ablative radiation therapy (IG-SABR) for patients with high-risk centrally located non-small cell lung cancer (NSCLC) tumors or a single pulmonary oligometastatic lesion. This phase II, non-randomized study focuses on patients whose disease cannot be treated with surgery and aims to assess side effects by monitoring the number and severity of treatment-related toxicities. Patients must meet specific criteria related to tumor and normal tissue radiation doses to be eligible. Treatment involves delivering radiation in 8 sessions (fractions), each with a dose of 7.5 Gy, using IG-SABR techniques that carefully target the tumor while respecting dose limits for surrounding normal tissues. The planning allows a minimum dose coverage between 75% and 95% of the planning target volume (PTV) and 75% to 99% of the gross tumor volume (GTV). Respiratory monitoring will be used during treatment, which employs photon beams of 6-10 MV energy. Optional translational sub-studies involve biomarker discovery and protein analysis and are available only at participating centers. Participants will be assessed weekly during treatment and at multiple time points after treatment, including 2, 4, 8 weeks, and then at 3, 6, 9, 12, 18, 24 months, followed by annual visits up to 5 years. These evaluations include toxicity monitoring and survival assessments. The main outcome measured is the rate of severe treatment-related toxicity within one year after treatment. The study aims to include 60 evaluable patients and will stop enrolling if excessive severe side effects occur. The study period includes up to 5 years of follow-up for long-term safety and effectiveness outcomes.

This research aims to understand how patients with cancer respond to COVID-19 vaccination by studying the levels of protective antibodies over time. The focus is on individuals with solid organ malignancies receiving various anti-cancer treatments such as chemotherapy, targeted therapy, and immunotherapy, as well as those who have been disease-free for at least six months. Since cancer patients were excluded from initial vaccine trials, this study seeks to fill knowledge gaps about vaccine safety and effectiveness in this group. Participants include cancer patients who are either undergoing active treatment or are disease-free for six months or more. They are grouped based on their treatment type: chemotherapy, targeted therapy, immunotherapy, or disease-free status. The study involves monitoring antibody trends related to COVID-19 infection and vaccination at multiple time points over a 12-month period. During the study, researchers will collect blood samples to measure neutralizing and spike antibody levels every three months for up to one year. Participants will be followed to track their immune response depending on their cancer treatment and biological aging status. The study will also assess how antibody levels change over time and correlate with different treatments and patient characteristics. Safety and consent are carefully monitored throughout the trial.

This research evaluates (Z)-endoxifen as a potential treatment for premenopausal women with estrogen receptor positive (ER+) and HER2-negative breast cancer. The study is open-label and includes two parts: a pharmacokinetic (PK) part to understand how the body processes the drug, and a treatment part to assess the drug's effect on tumor growth by measuring the biomarker Ki-67. The trial is sponsored by Atossa Therapeutics, Inc. and aims to determine if (Z)-endoxifen can slow or stop tumor growth in this patient group. Participants in the PK part receive daily (Z)-endoxifen capsules at doses of 20 mg, 40 mg, or 80 mg, with some also receiving a monthly injection of goserelin, which temporarily stops estrogen production by the ovaries. The treatment part uses a combination of (Z)-endoxifen at 40 mg daily plus monthly goserelin injections. After 4 weeks, tumor tissue is sampled via biopsy to measure Ki-67 levels. If Ki-67 is 10% or less, participants may continue treatment for up to 24 weeks; if greater than 10%, they proceed to surgery earlier. Participants attend regular visits for treatment and assessments, including blood tests and breast biopsies to monitor drug levels and tumor response. The main outcomes measured include (Z)-endoxifen blood concentrations and tumor Ki-67 reduction after 4 weeks, along with tumor response after 24 weeks. Study participation lasts up to 6 months, followed by surgery and a one-month follow-up to evaluate safety and treatment effects.

This trial investigates treatment options for patients with microsatellite stable (MSS) or proficient mismatch repair (pMMR) metastatic colorectal cancer who do not have active liver metastases. It is a phase II, prospective, randomized, open-label study conducted across multiple centers. The study aims to evaluate the effectiveness of Fruquintinib combined with Tislelizumab compared to a control treatment in this specific patient group. Participants will be randomly assigned to one of two groups. One group will receive Fruquintinib orally once daily for 21 days in a 28-day cycle along with Tislelizumab given intravenously every 42 days. The other group will receive Trifluridine/tipiracil orally twice daily on specific days of a 28-day cycle plus Bevacizumab intravenously every 14 days. Treatment will continue until disease progression, unacceptable side effects, patient choice, or a maximum of 15 months. During the study, patients will undergo regular assessments including imaging scans to monitor disease status, evaluations of side effects, and quality of life measures. Follow-up will continue for up to 18 months after the last patient begins treatment or until death, withdrawal, or loss to follow-up. Researchers will primarily measure the efficacy of the Fruquintinib and Tislelizumab combination, along with overall survival, response rates, safety, and quality of life.

Researchers are evaluating a combination treatment for men with prostate cancer that has spread to other parts of the body and continued to grow despite treatments that lower male hormones. This phase I trial compares the effects of a radioactive drug called lutetium Lu 177 (177^Lu)-PSMA-617 alone and combined with a vaccine therapy called Sipuleucel-T. The goal is to see if the combination can better stimulate the immune system and control the cancer. Participants are randomly assigned to one of two groups. One group receives 177^Lu-PSMA-617 intravenously every 6 weeks for up to 6 cycles, while the other group receives the same radioactive drug plus Sipuleucel-T starting at week 8, given every 2 weeks for up to 3 doses. Both groups undergo various imaging scans such as PET/CT, bone scans, MRI, and blood tests to monitor response and safety throughout the study. During the trial, patients have blood samples taken and may undergo leukapheresis (removal of certain blood cells for vaccine preparation). They are followed closely with scans and clinical visits during treatment and after completion. Follow-up visits occur at 30 days, then every 3 months for up to a year, and every 6 months until disease progression. Researchers measure immune response, safety, tumor response, progression-free survival, and overall survival over up to 3 years of observation.

Researchers are evaluating the safety and therapeutic response of a new drug called 177Lu-AB-3PRGD2 in patients with tumors that test positive for Integrin αVβ3. This drug is designed to target these specific tumors, which express this integrin highly, making it a promising option for diagnosis and treatment. The study is an early phase 1, open-label, non-controlled, and non-randomized trial focused on measuring the radiation absorbed dose and therapeutic effects in patients whose tumors show high uptake of the drug. Participants receive a single intravenous dose of 1.48 GBq (40 mCi) of 177Lu-AB-3PRGD2 within one week after a whole-body 68Ga-RGD PET/CT scan to confirm tumor suitability. After treatment, blood samples are collected at multiple time points to measure drug radioactivity. Patients undergo serial whole-body planar and SPECT/CT imaging at several intervals to monitor the radiation distribution and assess the treatment response. During the study, participants will be closely monitored with repeated imaging and blood tests at scheduled times up to 168 hours post-injection. Researchers will analyze the internal radiation dose absorbed by normal organs and tumors and collect data on any adverse events for up to two months. The primary outcome is the standardized uptake value of the drug in both tumors and normal tissues over a one-year period. The study involves adults aged 18 to 80 years with integrin-positive tumors that have not responded to standard treatments.

Researchers are evaluating 177Lu-BetaBart, a 177Lu-labeled anti-B7-H3 monoclonal antibody, in patients with various relapsed or refractory solid tumors that are locally advanced, inoperable, or metastatic. This Phase 1/2a study aims to understand the safety, tolerability, how the drug moves through and affects the body, and early signs of anti-tumor activity. Eligible participants include adults 18 and older with cancers such as castration-resistant prostate cancer, colorectal cancer, lung cancers, head and neck cancer, ovarian, cervical, endometrial, triple negative breast cancer, and esophageal squamous cell carcinoma who have shown disease progression after recent treatments. The study has two main parts: a Phase 1 dose escalation phase to find the maximum tolerated or recommended dose using a Bayesian design, and a Phase 2a dose expansion phase at that recommended dose to confirm safety and observe preliminary anti-tumor effects. Participants receive 177Lu-BetaBart through intravenous infusions every six weeks. Each phase includes a screening period, treatment and imaging period, and a safety and long-term follow-up period to closely monitor outcomes and side effects. During the study, participants undergo assessments including imaging for disease evaluation, laboratory tests for organ function and drug effects, and monitoring of side effects for up to 30 weeks. Key outcomes include determining the suitable dose for future studies, tracking adverse events, and measuring anti-tumor activity through objective response rates and biochemical responses in prostate cancer. Pharmacokinetics, radiation dosimetry, and biokinetics of the drug are also measured at specified time points. Safety and tolerability are evaluated continuously, with follow-up to monitor long-term effects and overall health.

Researchers are evaluating how well 177Lu-DOTATATE works to treat patients with stage IV or recurrent breast cancer that shows evidence of a protein called SSTR2. This phase II study explores whether this targeted therapy can shrink or destroy tumors and circulating cancer stem cells in the blood. 177Lu-DOTATATE combines a radioactive agent with DOTATATE, which attaches to tumor cells with SSTR2 to deliver targeted treatment. Participants receive 177Lu-DOTATATE intravenously over 30 to 40 minutes during weeks 1, 8, 16, and 24 if their disease does not progress and they do not experience unacceptable side effects. Before treatment, patients undergo imaging with gallium 68-DOTATATE PET/CT scans and biopsies as needed. Throughout the study, patients have CT or MRI scans and blood samples collected to monitor disease and treatment effects. After completing the treatment phase, participants are followed every 3 months for up to 5 years. The research team measures tumor response, disease control, duration of treatment effect, progression-free survival, and treatment safety. Blood tests, imaging, and biopsies help track how well the therapy works and any side effects, supporting long-term monitoring of patient health.