DECOY20 Study in Patients With Advanced Solid Tumors
Colon/Rectal Cancer
Liver Cancer / Hepatoblastoma
Lung Cancer
18 Years and older, Male and Female
INDP-D101 (primary)
NCI-2022-10991
Summary
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.
Objectives
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.
Eligibility
- Males or females, age 18 years or older.
- Histologically confirmed diagnosis of locally advanced or metastatic solid tumor. For Part 2, 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).
- Subject must have exhausted all available therapy or have declined treatment or treatment is contraindicated. Subjects with tumors that have known actionable molecular alteration such as EGFR, ALK, ROS-1, BRAF, RET, MET, and KRAS must have progressed on directed molecular therapy.
- Measurable disease (at least 1 measurable lesion) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as defined by tumor type.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of at least 3 months.
- Female subjects must be of non-childbearing potential (surgically sterile or at least 2 years postmenopausal) or agree to use a highly effective contraception method while receiving treatment with Decoy20 and for 30 days after the last dose of Decoy20.
- Male subjects must utilize reliable contraceptive precautions for the duration of Decoy20 treatment and 30 days after the last dose of Decoy20.
- Adequate organ function as demonstrated by baseline laboratory assessment
- Left ventricular ejection fraction (LVEF) = 45% by echocardiogram (ECHO) or multi gated acquisition scan (MUGA).
- Recovered from toxicities due to prior therapies.
- Willing and able to comply with all scheduled visits, laboratory tests, and other study procedures including mandatory pre-treatment and on-treatment biopsies for subjects enrolled to Part2.
Treatment Sites in Georgia
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