DECOY20 Study in Patients With Advanced Solid Tumors

Summary

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.