El Segundo

Researchers are evaluating the safety, tolerability, and overall survival of an experimental therapy called E-EDV-D682/GC combined with gemcitabine and nab-paclitaxel in participants with metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed after first-line therapy. This randomized, blinded Phase I/IIa trial focuses on participants whose cancer expresses the epidermal growth factor receptor (EGFR) and who have failed prior 5-fluorouracil-based treatments. The study aims to assess whether adding the investigational nanocell therapy improves outcomes compared to standard chemotherapy alone. The investigational treatment includes E-EDV-D682, which packages a chemotherapy drug (PNU-159682) inside targeted nanocells designed to deliver the drug directly to cancer cells expressing EGFR. It is combined with EDV-GC, another nanocell product carrying an immune-stimulating agent (alpha-galactosylceramide). Participants are randomized to receive either E-EDV-D682/GC with gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel with placebo. Treatment cycles involve bi-weekly and weekly visits with intravenous infusions, tumor assessments by imaging at week 8, and continued treatment until disease progression or unacceptable side effects occur. The study includes an initial safety run-in phase followed by a randomized expansion phase. Participants will be involved for about 6 months during active treatment, including screening, two 7-week treatment cycles with treatment-free weeks for tumor evaluation, and a safety follow-up visit about 30 days after the last dose. Researchers will monitor adverse events continuously from enrollment until 30 days after treatment ends, as well as overall survival from first dose through treatment and for at least 12 months after discontinuation. Assessments include imaging scans, laboratory tests, performance status, and compliance with treatment protocols to evaluate safety and effectiveness.

Researchers are evaluating the safety and early effectiveness of a combination treatment involving M-CENK adoptive cell therapy, N-803, and gemcitabine in women with platinum-resistant high-grade ovarian cancer. This phase 2, single-arm study focuses on participants whose cancer has returned despite prior platinum-based chemotherapy and aims to assess survival rates, response to treatment, and disease control over up to two years. Participants will first undergo a procedure to collect mononuclear cells for manufacturing M-CENK therapy. Starting with Cycle 1, gemcitabine will be given intravenously on Days 1, 8, and 15 of each 4-week cycle. From Cycle 2 onward, participants will receive M-CENK infusions intravenously on Day 1 of each cycle as long as cells are available, along with fixed doses of N-803 administered subcutaneously on Days 1 and 15. After the last M-CENK dose, additional N-803 doses are given to complete a total of five doses. Treatment continues until cell supply ends or disease progression is confirmed. Throughout the study, participants will be closely monitored with assessments including disease progression, survival, response rates, and biomarker evaluations like CA-125 levels. After treatment completion or discontinuation, follow-up visits will occur every 12 weeks for up to 12 months to track survival and disease status. The total study period includes initial treatment cycles and extended follow-up to evaluate long-term outcomes and safety.

Researchers are evaluating the safety and effectiveness of Anktiva, a drug being studied for treating patients with Long COVID, a condition where symptoms persist after a COVID-19 infection has cleared. This Phase 2 trial focuses on adults aged 18 to 70 years who have confirmed history of SARS-CoV-2 infection and ongoing symptoms that affect their quality of life and daily functioning. The study aims to better understand how Anktiva may impact these persistent symptoms and overall health. Participants will receive a subcutaneous injection of 600 micrograms of Anktiva. This is a single-arm study, meaning all participants receive the same treatment without a comparison group. The treatment period lasts approximately 75 days, during which participants are closely monitored for safety and any changes in their symptoms or health status. Throughout the study, participants will undergo regular assessments including vital signs (temperature, heart rate, blood pressure, respiratory rate, oxygen saturation), laboratory tests such as blood counts and metabolic panels, and monitoring for any side effects or serious adverse events. The primary focus is on identifying any treatment-related adverse effects up to 30 days after the final dose. Participants will be followed for a total duration that covers the treatment period and an additional safety monitoring phase to ensure well-being and collect comprehensive safety data.

Researchers are evaluating treatments for adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have developed resistance to immune checkpoint inhibitor therapy. This phase 3, randomized, two-cohort clinical trial compares the safety and effectiveness of N-803 combined with tislelizumab and docetaxel (cohort A), or prior failed immune checkpoint inhibitor therapy plus docetaxel (cohort B), against docetaxel alone. The study aims to understand if adding these treatments improves overall survival in participants with stage IV NSCLC who have specific genomic alterations or prior treatment histories. Participants will be divided into two groups (cohorts A and B) based on their prior treatment and genomic status. Each cohort is randomized 2:1 to receive the experimental combination or docetaxel monotherapy. Treatments involve N-803 given as a 1.2 mg subcutaneous injection, tislelizumab at 200 mg intravenously, and docetaxel at 75 mg/m2 intravenously. Cohort B includes participants who previously failed an approved checkpoint inhibitor therapy. Randomization accounts for factors like geographic region, tumor type, and genomic alterations. The study is open-label, so both participants and researchers know which treatment is given. During the study, participants will attend regular visits for treatment administration and monitoring. Researchers will assess tumor size using RECIST v1.1 criteria, track overall survival over approximately 12 months, and monitor safety. Assessments include clinical evaluations, laboratory tests, and imaging to measure tumor response and side effects. Participants must be able to follow-up as required and agree to contraception guidelines if applicable. The study excludes individuals with active infections, autoimmune diseases requiring treatment, recent major surgery, or inadequate organ function, ensuring safety and compliance throughout the trial.

Researchers are evaluating the safety and effectiveness of combination therapies involving NAI, PD-L1 t-haNK, bevacizumab, and Tumor Treating Fields (TTFields) in adults with recurrent or progressive glioblastoma (GBM). The study includes two parts: a phase 2 open-label, single-arm portion and a phase 2B open-label, randomized portion. The phase 2B portion compares two experimental treatment arms to assess their safety and efficacy in this patient population. During phase 2, participants receive repeated 28-day treatment cycles for up to 76 weeks, with infusions given every two weeks on Days 1 and 15. In phase 2B, participants are randomized to one of two treatment arms and receive repeated 8-week cycles for up to 80 weeks. Treatments include intravenous bevacizumab and PD-L1 t-haNK, subcutaneous N-803, and continuous use of the TTFields device, which delivers alternating electrical fields to disrupt cancer cell division. The TTFields device is portable and designed for daily use without disrupting normal activities. Participants undergo regular assessments including blood tests for metabolic, hematologic, and urinary changes; 12-lead ECGs; vital signs monitoring; neurological evaluations for neurotoxicity; and cytokine level measurements. These are conducted at baseline, throughout treatment cycles, and at the end of study visits. Safety and adverse events are closely monitored. After treatment discontinuation, participants are followed for up to five years to collect survival data, post-treatment therapies, and medical history information.

Researchers are evaluating AT-1965, an investigational drug, in a Phase 1/2 open-label study involving patients with advanced, refractory, or recurrent solid tumors, including metastatic triple-negative breast cancer. The study aims to find the maximum tolerated dose and recommended Phase 2 dose while assessing safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of AT-1965. This study includes patients whose tumors cannot be removed by surgery and who have few treatment options left. Participants will receive AT-1965 liposome injection intravenously once weekly for the first three weeks of each 4-week treatment cycle. The trial has two parts: a dose escalation phase to identify dose-limiting toxicities during the first 28-day treatment cycle, and a dose expansion phase to evaluate objective response rate and duration of response at 3, 6, and 9 months. The dose expansion specifically includes patients with metastatic triple-negative breast cancer who have had prior treatments. Throughout the study, participants will be monitored with assessments including safety evaluations, tumor measurements based on RECIST criteria, pharmacokinetic and pharmacodynamic testing, and adverse event tracking. Female participants of childbearing potential will have pregnancy tests and must use effective contraception. The trial also involves regular laboratory tests to check organ function and ongoing evaluations to detect any toxicities or side effects. Participation duration depends on treatment cycles and response assessments over several months.