Trials / Active Not Recruiting

Active Not RecruitingNCT05651022

Study of DECOY20 With or Without Tislelizumab in Patients With Advanced Solid Tumors

A Phase 1/2, Open-Label, Multi-Center, Dose Escalation and Expansion Study Evaluating the Safety, Tolerability and Clinical Activity of DECOY20 as Monotherapy and in Combination With Tislelizumab in Patients With Advanced Solid Tumors

Status: Active Not Recruiting
Phase: Phase 1 / Phase 2
Study type: Interventional
Enrollment: 120 (estimated)

Sponsor: Indaptus Therapeutics, Inc · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

INDP-D101 is a Phase 1/2, open-label, multi-center, dose escalation and expansion study evaluating the safety, tolerability and clinical activity of Decoy20 as monotherapy and in combination with tislelizumab in patients with locally advanced or metastatic solid tumors.

Detailed description

Decoy20, is a novel, systemically administered multiple Toll-like receptor (TLR) agonist-based cancer immunotherapy. INDP-D101 is a Phase 1/2, 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 2 parts: In Part 1, Subjects will receive a single dose of Decoy20 at one of up to three 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 began when a single dose recommended from Part 1 was identified to 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 3 parts a Safety Run-In (Part 2a), a Dose Expansion (Part 2b) and a Combination with a PD-1 inhibitor, tislelizumab (Part 2c). Part 2a enrolls 6 subjects in a staggered manner, and each subject receives 4 weekly doses of Decoy20 identified in Part 1. Safety data for each of these subjects is collected for 4 weeks after the subjects' 4th Decoy20 dose for acute and delayed toxicity. This data is reviewed by the SRC and a determination of one or more tolerable doses of Decoy20 for Part 2b is made. Part 2b further evaluates and confirms the safety and preliminary efficacy of continuous weekly Decoy20 administration for up to 1 year. The SRC continues to meet and reviews 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 one or more tolerable doses for Phase 2. Part 2c will evaluate the safety and tolerability of Decoy20 in combination with tislelizumab. The SRC will continue to meet and review data on an ongoing or ad-hoc basis during Part 2c of the study to ensure that there are no undue risks to study subjects and to confirm one or more tolerable Phase 2 doses and sequencing.

Conditions

Interventions

Type	Name	Description
DRUG	Decoy20	Decoy20 is a novel, systemically administered multiple Toll-like receptor (TLR) agonist-based cancer immunotherapy.
DRUG	Tislelizumab	Tislelizumab is a PD-1 inhibitor.

Timeline

Start date: 2023-02-28
Primary completion: 2027-06-30
Completion: 2027-09-30
First posted: 2022-12-14
Last updated: 2026-01-13

Locations

12 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT05651022. Inclusion in this directory is not an endorsement.