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

NCT05651022 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-01-13

No results posted yet for this study

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.

Conditions

  • Solid Tumor, Adult
  • HCC - Hepatocellular Carcinoma
  • CRC (Colorectal Cancer)
  • Pancreatic Adenocarcinoma
  • NSCLC Non-small Cell Lung Cancer
  • Squamous Cell Cancer of the Head and Neck
  • UC (Urothelial Cancer)
  • MSI-H Cancer

Interventions

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.

Sponsors & Collaborators

  • Translational Drug Development

    collaborator OTHER

  • Indaptus Therapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • Indaptus Therapeutics · Indaptus Therapeutics, Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2027-06-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05651022 on ClinicalTrials.gov