ASND0029: IL Believe: A Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study to Investigate the Safety and Tolerability of TransCon IL-2 / Alone or in Combination with Pembrolizumab, Standard of Care Chemotherapy, or TransConTLR7/8 Agonist, or in Combination with Pembrolizumab and Standard of Care Chemotherapy, in Adult Participants with Locally Advanced or Metastatic Solid Tumor Malignancies
Study of TransCon IL-2 / vs. TransCon TLR7/8 Agonist in Patients with Gynecologic Cancer
Sponsor: Ascendis Pharma
Enrolling: Female Patients Only
IRB Number: AAAU5021
U.S. Govt. ID: NCT05081609
Contact: Reena Vattakalam: 212-342-6895 / rmv2110@cumc.columbia.edu
Additional Study Information: The purpose of this research is to learn about what effects, both good and/or bad, an experimental drug called TransCon IL-2 / has when given by itself SOC chemotherapy, or experimental drug called TransCon TLR7/8 Agonist, or in combination with SOC chemotherapy. TransCon IL-2 / works by blocking the reproduction and spread of cancer cells. The study drugs TransCon IL-2 / and TransCon TLR7/8 Agonist (TLR7/8) have not been approved by the Food and Drug Administration FDA for your type of cancer. We also want to find a dose of TransCon IL-2 / that is safe and tolerable for adult patients who have advanced cancers, whose cancer came back after standard treatment, or whose disease has not responded to standard cancer treatment. We are also trying to decide on the best dose that patients can take safely for use in future studies. This is a first in human study. We are also studying the effect of the study drug on your cancer. To do this, biomarker, immune cell characterization and circulating tumor DNA (ctDNA) studies will be included in this trial. Biomarkers are important biological indicators that can be measured from blood and tumor tissues. ctDNA in your blood will be assessed to monitor the status of your disease and mutation in your cancer cells. Since TransCon IL-2 / may boost your own immune system to fight cancer, immune cell characterization labs will be drawn to measure the function of your immune cells in response to taking the drug. Biomarker, immune cell characterization and ctDNA samples will be collected before you start your treatment with the study drug(s) in this trial and then at various times while you are on the study treatment. With these samples, researchers can make a comparison to assess whether the study drugs are having an effect on your cancer and what effects, if any, are happening.
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Have you been diagnosed with ovarian, fallopian, cervical or primary peritoneal cancer (PPC)? Yes No
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For more information, please contact:
Reena Vattakalam
rmv2110@cumc.columbia.edu
212-342-6895