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NCT05651022 · ClinicalTrials.gov registry record · Phase 1
Study of DECOY20 With or Without Tislelizumab in Patients With Advanced Solid Tumors
A Phase 1 study of Solid Tumor, Adult and Pancreatic Adenocarcinoma, sponsored by Indaptus Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
- 12
- Study locations
NCT05651022: Active Phase 1 study of Solid Tumor, Adult and Pancreatic Adenocarcinoma, sponsored by Indaptus Therapeutics.
NCT05651022 is a Phase 1 study of Solid Tumor, Adult and Pancreatic Adenocarcinoma that is active but no longer recruiting, run by Indaptus Therapeutics. The registered enrollment target is 120 participants, below the 189-participant average among 72 other Solid Tumor, Adult trials with a reported enrollment target (37% lower). The trial reports 12 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05651022, a Phase 1 study of Solid Tumor, Adult and Pancreatic Adenocarcinoma, is active but no longer recruiting, sponsored by Indaptus Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
- 12
- Study locations
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.
Primary Outcome
A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medication. The relatedness and severity of treatment emergent adverse events will utilize the National Cancer Institute Common Toxicity Criteria for adverse events (NCI-CTCAE) for assessment.
Conditions Studied
Interventions
- DRUG Tislelizumab
- DRUG Decoy20
Study Locations (12)
Ohio
- Gabrail Cancer & Research Center - Canton
- UH Seidman Cancer Center - Cleveland
- Cleveland Clinic Taussig Cancer Center - Cleveland
California
- University of Southern California- Norris Cancer Center - Los Angeles
- Hoag Memorial Hospital Presbyterian - Newport Beach
Georgia
- Winship Cancer Institute of Emory University - Atlanta
Michigan
- The Barbara Ann Karmanos Cancer Institute - Detroit
Missouri
- Washington University, Siteman Cancer Center - St Louis
New Jersey
- Atlantic Health System - Morristown
New York
- Roswell Park Comprehensive Cancer Center - Buffalo
Pennsylvania
- Fox Chase Cancer Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-02-28 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 1 |
What the registry record for NCT05651022 still lists
NCT05651022 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 189-participant average among 72 other Solid Tumor, Adult trials with a reported enrollment target (37% lower).
The record links to 8 conditions, with Solid Tumor, Adult appearing as the primary indexed condition, and to 2 interventions - of which Tislelizumab is the first listed.
NCT05651022 lists 12 locations in 9 states (Ohio, California, Georgia).
Frequently Asked Questions
What is clinical trial NCT05651022 about?
NCT05651022 is a clinical study titled "Study of DECOY20 With or Without Tislelizumab in Patients With Advanced Solid Tumors". 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.
What is the current status of trial NCT05651022?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2023-02-28. Estimated completion is 2027-09-30.
What conditions does trial NCT05651022 study?
This clinical trial studies the following conditions: Solid Tumor, Adult, Pancreatic Adenocarcinoma, NSCLC (Non-small Cell Lung Cancer), CRC, Colorectal Cancer, MSI-H Cancer.
What interventions are being tested in trial NCT05651022?
The interventions under investigation include: Tislelizumab (DRUG), Decoy20 (DRUG).
Who is sponsoring clinical trial NCT05651022?
This trial is sponsored by Indaptus Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05651022 being conducted?
This trial has 12 study locations across California, Georgia, Michigan, Missouri, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05651022's enrollment target sits among peer trials
120 36th of 72 higher than 37 of 72 other Solid Tumor, Adult trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumor, Adult trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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