Decoy20 for Solid Tumors

Recruiting at 13 trial locations

Overseen By Indaptus Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Indaptus Therapeutics, Inc

Must not be taking: Corticosteroids, Chemotherapy, Immunotherapy, others

Disqualifiers: Pregnancy, Active infection, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of a new treatment called Decoy20, which may benefit people with advanced solid tumors. Researchers are testing Decoy20 alone and in combination with another drug, tislelizumab, to evaluate its effectiveness against these challenging cancers. Individuals diagnosed with solid tumors such as liver, colorectal, or lung cancer, who have exhausted all other available treatments, might be suitable candidates for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Decoy20 appears promising in early studies. Safety data from one study found that most side effects were mild and brief. Among 11 patients who received Decoy20, the common side effects were mild and short-lived.

When combined with another treatment called tislelizumab, safety data from other studies of tislelizumab indicate it has a consistent safety profile. This means it typically behaves predictably and rarely causes severe side effects, whether used alone or with other treatments.

Since this trial is in the early stages, it primarily focuses on assessing the safety and tolerability of Decoy20 in humans. While much remains to be learned, initial data suggest that the treatment is generally safe. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for solid tumors?

Unlike the standard treatments for solid tumors, which often include chemotherapy, radiation, and immunotherapy targeting PD-1 or PD-L1, Decoy20 stands out with its innovative mechanism. Decoy20 is an experimental therapy that mimics certain tumor signals to "decoy" and neutralize cancer-promoting factors, potentially disrupting tumor growth more directly. Researchers are particularly excited about combining Decoy20 with the immunotherapy drug tislelizumab, which could enhance the immune response against tumors. This combination might offer a more targeted approach, potentially leading to more effective treatments with fewer side effects.

What evidence suggests that Decoy20 might be an effective treatment for solid tumors?

Research has shown that Decoy20 has promising results in early studies. In this trial, participants may receive Decoy20 alone or with other treatments. Early results demonstrated that Decoy20 broadly activated the immune system, and some patients achieved stable disease after just one dose. In one trial arm, Decoy20 is combined with the drug tislelizumab to enhance the effects of current cancer treatments. Tislelizumab helps some cancer patients, though not everyone benefits from it. Together, these treatments could provide new options for people with advanced solid tumors. ^{1 2 3 6 7}

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

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.

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.

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?

Group I: Parts 2a and 2b Experimental Treatment 1 Intervention

Decoy20 administered weekly at a dose of 3 x 10\^7 KB or 7 x 10\^7 KB

Group II: Part 2c Experimental Treatment 2 Interventions

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.

Group III: Part 1 Experimental Treatment 1 Intervention

A single dose of Decoy20 at a dose of 3 x 10\^7 KB or 7 x 10\^7 KB

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

In a study of 19 ovarian cancer patients treated with olaparib over a median duration of 12 months, 95% experienced adverse events (AEs), with the most common being fatigue, nausea, and anemia, indicating that while AEs are prevalent, they are often manageable.

The study found that dose modifications for managing AEs were effective, with eight patients requiring dose adjustments and five successfully re-escalating their doses, suggesting that olaparib can be safely administered with careful monitoring and management of side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Olaparib dose re-escalation in ovarian cancer patients who experienced severe and/or uncommon adverse events: A case series. Ngu, SF., Tse, KY., Chu, MMY., et al.[2021]

In the PELICAN trial involving 210 patients with metastatic breast cancer, pegylated liposomal doxorubicin (PLD) and capecitabine showed similar efficacy, with a median time-to-disease progression of 6.0 months for both treatments.

However, capecitabine was associated with a higher incidence of serious adverse events compared to PLD, suggesting that PLD may have a better safety profile, especially for patients with prior anthracycline exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized phase III study evaluating pegylated liposomal doxorubicin versus capecitabine as first-line therapy for metastatic breast cancer: results of the PELICAN study. Harbeck, N., Saupe, S., Jäger, E., et al.[2018]

Antibody-drug conjugates (ADCs) can potentially treat solid tumors more effectively due to a phenomenon called the bystander effect, where the drug can diffuse from targeted cancer cells to neighboring cells that do not express the target antigen.

Preclinical studies show promising evidence for the bystander effect, suggesting that certain drug characteristics, like a hydrophobic payload or cleavable linker, enhance this effect, but more clinical research is needed to confirm its importance in achieving effective treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bystander effect of antibody-drug conjugates: fact or fiction? Giugliano, F., Corti, C., Tarantino, P., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recurrent ovarian cancer: treatment with pegylated liposomal doxorubicin; a Westmead Cancer Care Centre experience. Dear, RF., Gao, B., Harnett, P.[2018]

In a study involving 1738 patients with advanced solid tumors treated with avelumab, a PD-L1 antibody, only 10.2% experienced grade ≥3 treatment-related adverse events (TRAEs), indicating a generally well-tolerated safety profile.

Infusion-related reactions (IRRs) were common, occurring in 25.3% of patients, primarily at the first infusion, but serious IRRs (grade ≥3) were rare, suggesting that while some patients may experience reactions, they are typically manageable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Kelly, K., Infante, JR., Taylor, MH., et al.[2020]

The study developed doxorubicin-loaded platelet decoys (PD@Dox) that not only deliver chemotherapy but also induce immunogenic cell death (ICD) in triple-negative breast cancer (TNBC), enhancing the immune response against tumors.

Combining PD@Dox with PD-1 antibody therapy significantly improved treatment efficacy by blocking tumor immune escape and activating T cells, suggesting a promising new approach for TNBC therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Doxorubicin-Loaded Platelet Decoys for Enhanced Chemoimmunotherapy Against Triple-Negative Breast Cancer in Mice Model. Dong, H., Gao, M., Lu, L., et al.[2023]

In a meta-analysis of 143 phase 3 randomized controlled trials involving 88,603 patients with advanced cancers, experimental drugs showed improved progression-free survival (PFS) and overall survival (OS) compared to control groups, with hazard ratios of 0.80 and 0.87, respectively.

However, these experimental treatments were associated with higher rates of toxic deaths, treatment discontinuations without progression, and severe adverse events, indicating that while they may be more effective, they also come with increased safety risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, safety and tolerability of drugs studied in phase 3 randomized controlled trials in solid tumors over the last decade. Ribnikar, D., Goldvaser, H., Veitch, ZW., et al.[2021]

Antibody-drug conjugates (ADCs) are a promising cancer treatment that combines targeted monoclonal antibodies with cytotoxic agents to deliver drugs directly to cancer cells, minimizing harm to healthy cells.

Despite their targeted approach, ADCs can still cause adverse events due to early payload release or target expression in normal cells, highlighting the need for careful monitoring and dose adjustments to optimize their safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for Mitigating Antibody-Drug Conjugate Related Adverse Events for Precision Therapy. Gouda, MA., Subbiah, V.[2022]

Citations

1. jitc.bmj.com jitc.bmj.com/content/12/Suppl_3/A1726

1497 Preliminary results of a phase 1 study of Decoy20, an ... Decoy20 produced pre-clinical single-agent and combination-mediated anti-tumor activity including innate/adaptive immune-mediated eradication of ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.2583

Preliminary results of a phase 1 study of Decoy20, an ... Broad systemic immune activation and preliminary evidence of stable disease were observed with only one infusion of Decoy20. These observations ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05651022

NCT05651022 | Study of DECOY20 With or Without ... A Phase 1/2, open-label, multi-center, dose escalation and expansion study evaluating the safety, tolerability and clinical activity of Decoy20 as monotherapy.

4. biospace.com biospace.com/indaptus-therapeutics-announces-new-positive-data-from-ongoing-phase-1-trial-of-decoy20

Indaptus Therapeutics Announces New Positive Data from ... Indaptus Therapeutics, Inc today announced updated data from its ongoing Phase 1 clinical trial of Decoy20 in patients with solid tumors.

5. indaptusrx.com indaptusrx.com/wp-content/uploads/2024/11/preliminary-results-of-a-phase-1-study-of-decoy20-an-intravenous-killed-multiple-immune-receptor-agonist-bacterial-product-in-patients-with-advanced-solid-tumor.pdf

Preliminary results of a Phase 1 study of Decoy20, an ... Weekly administration of Decoy20 3x107 (n = 6) revealed mostly grade (G) 1-2 adverse events (AEs). The most commonly observed AE (Table 3) ...

6. georgiacancerinfo.org georgiacancerinfo.org/clinical-trials/detail/5369

DECOY20 Study in Patients With Advanced Solid Tumors Phase 0: The first clinical trials done among people. · Phase I: Tests the safety of a drug in healthy volunteers or subjects with indications. · Phase II:

7. indaptusrx.com indaptusrx.com/wp-content/uploads/2024/06/Indaptus-ASCO-2024-Poster.pdf

Preliminary results of a Phase 1 study of Decoy20, an ... Safety Summary: Safety data reveal limited high-grade and short-duration AEs. The most commonly observed related AEs (see Table 2) among 11 ...