Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Decoy20 · 1 trial · 8 indications
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.
The count and percentage of subjects with AEs and Treatment Emergent Adverse Events (TEAEs) will be assessed for all subjects.
The MTD is defined as the highest dose level at which no more than 1 out of 6 subjects experiences Dose Limiting Toxicity during the first 28 days after dosing of Decoy20.
The highest dose level that is declared to be safe and tolerable by the investigators and the sponsor.
| Arm | Type | Description |
|---|---|---|
| Part 1 | EXPERIMENTAL | A single dose of Decoy20 at a dose of 3 x 10\^7 KB or 7 x 10\^7 KB |
| Parts 2a and 2b | EXPERIMENTAL | Decoy20 administered weekly at a dose of 3 x 10\^7 KB or 7 x 10\^7 KB |
| Part 2c | EXPERIMENTAL | Decoy20 administered weekly at either 3 x 10\^7 KB or 7 x 10\^7 KB. Both will be administered with tislelizumab at 200mg Q3W. |
| Name | Type | Description |
|---|---|---|
| Decoy20 | DRUG | Decoy20 is a novel, systemically administered multiple Toll-like receptor (TLR) agonist-based cancer immunotherapy. |
| Tislelizumab | DRUG | Tislelizumab is a PD-1 inhibitor. |
Inclusion Criteria: 1. Males or females, age 18 years or older. 2. 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...
Decoy20 is an investigational small molecule being studied for the treatment of advanced solid tumors in adults, including hepatocellular carcinoma, colorectal cancer, pancreatic adenocarcinoma, non-small cell lung cancer, squamous cell cancer of the head and neck, urothelial cancer, and MSI-H cancer. It is currently in Phase 1 clinical development.
Decoy20 targets PD-1, a protein involved in immune checkpoint regulation. By targeting PD-1, Decoy20 is designed to modulate the immune response against tumor cells. It is being evaluated in combination with tislelizumab in a clinical trial for advanced solid tumors.
Decoy20 is being developed by Indaptus Therapeutics, Inc., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol INDP. Indaptus Therapeutics is conducting clinical trials to evaluate the safety and efficacy of Decoy20 in patients with advanced solid tumors.
Decoy20 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is active but not recruiting participants, and it is designed to assess the drug's safety, tolerability, and preliminary efficacy in advanced solid tumors.
Decoy20 is being studied in a Phase 1 clinical trial with the identifier NCT05651022. The trial is titled 'Study of DECOY20 With or Without Tislelizumab in Patients With Advanced Solid Tumors' and is being conducted in the United States. The trial enrolls adults aged 18 years and older with various advanced solid tumors.
Yes, Decoy20 and DECOY20 refer to the same investigational drug. The drug name is presented in different capitalizations, but both names identify the same small molecule being developed by Indaptus Therapeutics. In clinical trial records, it is referred to as DECOY20.