Solid Tumor, Adult Clinical Trial
Official title:
A Phase 1, Open-Label, Multi-Center, Dose Escalation and Expansion Study Evaluating the Safety, Tolerability and Clinical Activity of DECOY20 in Patients With Advanced Solid Tumors
INDP-D101 is a Phase 1, open-label, multi-center, dose escalation and expansion study evaluating the safety, tolerability and clinical activity of Decoy20 in patients with locally advanced or metastatic solid tumors.
Decoy20, is a novel, systemically administered multiple Toll-like receptor (TLR) agonist-based cancer immunotherapy. INDP-D101 is a Phase 1, open-label, multi-center, 3+3 dose escalation and expansion study evaluating the safety, tolerability and clinical activity of Decoy20 in subjects with advanced solid tumors. The study will include 3 parts: In Part 1, Subjects will receive a single dose of Decoy20 at one of up to seven assigned dose levels on Week 1 Day 1 (SAD). Subjects will be observed for 28 days for dose limiting toxicity. Safety will be assessed by a safety review committee (SRC), comprised of investigators and the study sponsor, and subsequently will recommend the dose of Decoy20 to take forward. Part 2 will begin when the single dose recommended from Part 1 is identified and it will confirm the safety of weekly administration of Decoy20 in approximately 54 to 90 subjects. More than one dose may be studied in Part 2 that is at or below the MTD determined in Part 1. Eligible subjects must have one of the following locally advanced or metastatic tumor types: hepatocellular carcinoma (HCC), colorectal cancer (CRC) with liver metastasis, urothelial cancer, squamous cell carcinoma of the head and neck (SCCHN), adenocarcinoma of the pancreas, non-small cell lung cancer (NSCLC). Part 2 is further divided into 2 parts a Safety Run-In (Part 2a) and a Dose Expansion (Part 2b). Part 2a will enroll 6 subjects in a staggered manner, and each subject will receive 4 weekly doses of Decoy20 identified in Part 1. Safety data for each of these subjects will be collected for 4 weeks after the subjects' 4th Decoy20 dose for acute and delayed toxicity. This data will be reviewed by the SRC and the determination of the Decoy20 dose for Part 2b made. Part 2b will further evaluate and confirm the safety and preliminary efficacy of continuous weekly Decoy20 administration for up to 1 year. The SRC will continue to meet and review data on an ongoing or ad-hoc basis during Part 2b of the study to ensure that there are no undue risks to study subjects and to confirm the RP2D and regimen. ;
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