Decoy20 for Solid Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot have received chemotherapy, targeted therapy, or immunotherapy within 28 days before starting the trial, and you should not be on systemic corticosteroids above a certain dose.
What safety data exists for Decoy20 in solid tumors?
What data supports the effectiveness of the drug Decoy20 for treating solid tumors?
Who Is on the Research Team?
Indaptus Therapeutics
Principal Investigator
Indaptus Therapeutics, Inc
Are You a Good Fit for This Trial?
Adults with advanced metastatic solid tumors who have had 1-3 prior treatments and progressed or were intolerant. They must have measurable disease, be in good physical condition (ECOG 0 or 1), not pregnant, using effective contraception, and have a life expectancy of at least 3 months. Participants need proper heart function (LVEF ≥45%) and adequate organ function.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation (Part 1)
Subjects receive a single dose of Decoy20 at one of up to three assigned dose levels and are observed for 28 days for dose limiting toxicity.
Safety Run-In (Part 2a)
Subjects receive 4 weekly doses of Decoy20 identified in Part 1, with safety data collected for 4 weeks after the 4th dose.
Dose Expansion (Part 2b)
Continuous weekly administration of Decoy20 for up to 1 year to evaluate safety and preliminary efficacy.
Combination Therapy (Part 2c)
Evaluation of Decoy20 in combination with tislelizumab, with ongoing safety and tolerability assessments.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion.
What Are the Treatments Tested in This Trial?
Interventions
- Decoy20
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indaptus Therapeutics, Inc
Lead Sponsor
Translational Drug Development
Collaborator