120 Participants Needed

Decoy20 for Solid Tumors

Recruiting at 12 trial locations
IT
Overseen ByIndaptus Therapeutics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

There is no specific safety data available for Decoy20 in the provided research articles.12345

What data supports the effectiveness of the drug Decoy20 for treating solid tumors?

Research on similar treatments, like doxorubicin-loaded platelet decoys, shows potential in enhancing cancer therapy by combining chemotherapy with immune system activation, which might suggest a similar approach could be effective for Decoy20 in solid tumors.678910

Who Is on the Research Team?

IT

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

My organs are working well, according to recent tests.
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as defined by tumor type
I will use reliable birth control during and for 30 days after Decoy20 treatment.
See 8 more

Exclusion Criteria

I have not had major uncontrolled bleeding or blood clot issues recently.
I don't have any health or mental conditions that could make this study riskier for me.
I am currently fighting an infection that needs treatment.
See 19 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

4 weeks
1 visit (in-person) for dosing, followed by observation

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.

8 weeks
4 visits (in-person) for dosing, followed by observation

Dose Expansion (Part 2b)

Continuous weekly administration of Decoy20 for up to 1 year to evaluate safety and preliminary efficacy.

up to 52 weeks

Combination Therapy (Part 2c)

Evaluation of Decoy20 in combination with tislelizumab, with ongoing safety and tolerability assessments.

up to 52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment completion.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Decoy20
Trial Overview The DECOY20 Study is testing the safety and effectiveness of a new treatment called Decoy20 for patients with advanced solid tumors. This Phase 1 trial involves gradually increasing doses to find the right balance between safety and potential benefits.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Parts 2a and 2bExperimental Treatment1 Intervention
Group II: Part 2cExperimental Treatment2 Interventions
Group III: Part 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Indaptus Therapeutics, Inc

Lead Sponsor

Trials
1
Recruited
120+

Translational Drug Development

Collaborator

Trials
19
Recruited
1,000+

Published Research Related to This Trial

A new ex vivo 3D screening platform using patient-derived tumor cells and immune cells effectively predicts patient responses to treatments like chemotherapy and immunotherapy in high-grade serous ovarian cancer (HGSOC).
Epigenetic priming significantly enhances the effectiveness of immune checkpoint blockade (ICB) therapies by increasing the activation of immune cells and the secretion of key cytokines, suggesting a promising strategy for personalized cancer treatment.
Development of a Patient-Derived 3D Immuno-Oncology Platform to Potentiate Immunotherapy Responses in Ascites-Derived Circulating Tumor Cells.Gerton, TJ., Green, A., Campisi, M., et al.[2023]
In a retrospective study of 45 patients with recurrent ovarian cancer treated with pegylated liposomal doxorubicin (PLD), the overall response rate was only 14%, indicating limited efficacy, especially in platinum-resistant cases.
The median overall survival was 296 days (about 10.6 months), with a notable difference in survival between platinum-sensitive (13 months) and platinum-resistant (9 months) groups, highlighting the need for further research on treatment benefits and quality of life.
Recurrent ovarian cancer: treatment with pegylated liposomal doxorubicin; a Westmead Cancer Care Centre experience.Dear, RF., Gao, B., Harnett, P.[2018]
In a Phase I trial involving 22 patients with advanced malignancies, the maximum tolerated dose (MTD) for pegylated liposomal doxorubicin (PEG-LD) and docetaxel was determined to be 20 mg/m² and 40 mg/m², respectively, when administered on Days 1 and 15 of a 28-day cycle.
The study found that the combination treatment was generally well tolerated, with dose-limiting toxicities including Grade 3 skin toxicity and thrombocytopenia, and it showed some efficacy with one partial response and stable disease in three patients.
Phase I dose and sequencing study of pegylated liposomal doxorubicin and docetaxel in patients with advanced malignancies.Fracasso, PM., Rodriguez, LC., Herzog, TJ., et al.[2018]

Citations

Development of a Patient-Derived 3D Immuno-Oncology Platform to Potentiate Immunotherapy Responses in Ascites-Derived Circulating Tumor Cells. [2023]
Recurrent ovarian cancer: treatment with pegylated liposomal doxorubicin; a Westmead Cancer Care Centre experience. [2018]
Phase I dose and sequencing study of pegylated liposomal doxorubicin and docetaxel in patients with advanced malignancies. [2018]
A randomized phase III study evaluating pegylated liposomal doxorubicin versus capecitabine as first-line therapy for metastatic breast cancer: results of the PELICAN study. [2018]
Doxorubicin-Loaded Platelet Decoys for Enhanced Chemoimmunotherapy Against Triple-Negative Breast Cancer in Mice Model. [2023]
Safety profile of avelumab in patients with advanced solid tumors: A pooled analysis of data from the phase 1 JAVELIN solid tumor and phase 2 JAVELIN Merkel 200 clinical trials. [2020]
Bystander effect of antibody-drug conjugates: fact or fiction? [2022]
Strategies for Mitigating Antibody-Drug Conjugate Related Adverse Events for Precision Therapy. [2022]
Efficacy, safety and tolerability of drugs studied in phase 3 randomized controlled trials in solid tumors over the last decade. [2021]
Olaparib dose re-escalation in ovarian cancer patients who experienced severe and/or uncommon adverse events: A case series. [2021]
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