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Solid Tumor, AdultPhase 1/2NCT05651022

Study of DECOY20 With or Without Tislelizumab in Patients With Advanced Solid Tumors

A Phase 1/2 study testing Decoy20 and Tislelizumab in people with Solid Tumor, Adult and HCC - Hepatocellular Carcinoma, run by Indaptus Therapeutics, Inc at 12 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Decoy20 and Tislelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
12 sitesUnited States
Study dates
28 Feb 2023to 30 Sep 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males or females, age 18 years or older.
  • 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) with liver metastasis, urothelial cancer, squamous cell carcinoma of the head and neck (SCCHN), adenocarcinoma of the pancreas, non-small cell lung cancer (NSCLC), dMMR/MSI-High tumor (Part 2c only).
  • Subject must have exhausted all available therapy or have declined treatment or treatment is contraindicated. Subjects with tumors that have known actionable molecular alteration such as EGFR, ALK, ROS-1, BRAF, RET, MET, and KRAS must have progressed on directed molecular therapy. For Part 2c, participants with a tumor type for which a CPI has been approved must have received a CPI during one or more lines of therapy.
  • Measurable disease (at least 1 measurable lesion) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as defined by tumor type.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy of at least 3 months.
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  • Female subjects must be of non-childbearing potential (surgically sterile or at least 2 years postmenopausal) or agree to use a highly effective contraception method while receiving treatment with Decoy20 and for 30 days after the last dose of Decoy20.
  • Male subjects must utilize reliable contraceptive precautions for the duration of Decoy20 treatment and 30 days after the last dose of Decoy20.
  • Adequate organ function as demonstrated by baseline laboratory assessment.
  • Left ventricular ejection fraction (LVEF) ≥ 45% by echocardiogram (ECHO) or multi-gated acquisition scan (MUGA).
  • Recovered from toxicities due to prior therapies.
  • Willing and able to comply with all scheduled visits, laboratory tests, and other study procedures including mandatory pre-treatment and on- treatment biopsies for subjects enrolled to Part2.

Who cannot join

  • Pregnant or lactating females.
  • Has an active systemic (viral, bacterial, or fungal) infection or requiring treatment.
  • Received radiotherapy within 28 days of the first dose of Decoy20. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
  • Received prior chemotherapy, targeted therapy or immunotherapy within 28 days or 5 half-lives from W1D1, whichever is shorter.
  • Received systemic corticosteroid therapy > 5 mg/day of prednisone or equivalent dose of another corticosteroid within 1 week or 5 half-lives (whichever is shorter) from the start of study drug or is expected to require it during the course of the study (topical and inhaled steroids are permitted).
  • Has radiographically detected primary central nervous system (CNS) metastases or symptomatic CNS involvement (including leptomeningeal carcinomatosis, cranial neuropathies or mass lesions that cause spinal cord compression). Participants with brain metastases (either treated or deemed unnecessary to treat) that have been stable by neuroimaging for at least 4 weeks will be eligible.
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  • Clinical evidence of significant coagulopathy during Screening (e.g., deep vein thrombosis or pulmonary embolism) or history of significant uncontrolled coagulopathy (participants with HCC must have prothrombin time (PT) < 4 seconds above ULN or international normalized ratio [INR] < 1.7) or participants with diagnosis of a new thrombotic event within 90 days prior to Decoy20 dosing.
  • Has an active secondary malignancy in addition to the primary, excluding low-risk neoplasms as determined by the Investigator (e.g., non-metastatic basal cell or squamous cell skin carcinoma) and other indolent malignancies will be allowed after discussion with the Sponsor).
  • Has a history of or active infection with HIV 1 or 2, a history of or active infection with HBV based upon HBV antigenemia or viral load, or positive read for hepatitis C virus ([HCV] viral load >15 IU/mL) at Screening. 10. Has a history of known genetic predisposition to HLH/MAS.
  • 11. Has undergone splenectomy, has an active chronic liver disease, Wilson's disease, hemochromatosis, primary biliary cirrhosis, primary sclerosing cholangitis, genetic hemochromatosis, history of or planned liver transplant for end-stage liver disease of any etiology, documented history of advanced liver fibrosis or history of cirrhosis and/or hepatic decompensation including ascites requiring paracentesis rather than medical therapy, modified Child-Pugh B or C, clinically relevant hepatic encephalopathy within the preceding 6 months, or variceal bleeding. 12. Has received a vaccine within 14 days of W1D1 13. Has active autoimmune disease. 14. Has a history of significant CNS disease, such as stroke (past history of transient ischemic attacks more than 3 months ago and controlled is allowed) or uncontrolled and unstable epilepsy. 15. Has severe pulmonary interstitial disease and/or oxygen saturation on room air < 92%. 16. Baseline Q-T correlated (QTc) interval of > 470 msec for females and > 450 msec for males calculated using Fridericia's formula. 17. New York Heart Association Class III or IV cardiac disease, or myocardial ischemia or infarction within 180 days of Screening, vaso-vagal sensitivity, unstable angina, coronary/peripheral artery bypass graft, worsening/ decompensated heart failure within the past 6 months, or any other clinically significant cardiac abnormality that, in the judgement of the Investigator, would pose a health risk to the subject. 18. Major surgical procedure within 4 weeks prior to first dose of Decoy20, or anticipation of need for a major surgical procedure, during the study. 19. Any other acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or Decoy20 administration. 20. Has received investigational therapy within 28 days or 5 half-lives of the start of study drug. 21. Unwillingness or inability to comply with procedures required in this protocol. 22. Known allergy or hypersensitivity to Decoy20 or one of the ingredients of Decoy20. 23. For Part 2c, participants with ongoing immune-related adverse events (irAEs) from other agents or who required permanent discontinuation of prior ICIs due to irAEs. Participants with a prior history of Grade 3 or higher irAE except for those with a history of an immune-related endocrinopathy which is currently treated and clinically stable. Participants with a history of (non-infectious) Grade 2 or higher pneumonitis that required steroids.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263

  • Gabrail Cancer & Research Center

    Canton, Ohio, 44718

  • UH Seidman Cancer Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • The Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Prisma Health Cancer Institute-ITOR

    Greenville, South Carolina, 29605

  • University of Southern California- Norris Cancer Center

    Los Angeles, California, 90033

  • Atlantic Health System

    Morristown, New Jersey, 07960

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Washington University, Siteman Cancer Center

    St Louis, Missouri, 63108

Other trials in United States

About this study

Official title: 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 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.

Read the detailed description

Decoy20, is a novel, systemically administered multiple Toll-like receptor (TLR) agonist-based cancer immunotherapy.

INDP-D101 is a Phase 1/2, open-label, multi-center, 3+3 dose escalation and expansion study evaluating the safety, tolerability and clinical activity of Decoy20 in subjects with advanced solid tumors. The study will include 2 parts:

In Part 1, Subjects will receive a single dose of Decoy20 at one of up to three assigned dose levels on Week 1 Day 1 (SAD). Subjects will be observed for 28 days for dose limiting toxicity. Safety will be assessed by a safety review committee (SRC), comprised of investigators and the study sponsor, and subsequently will recommend the dose of Decoy20 to take forward.

Part 2 began when a single dose recommended from Part 1 was identified to confirm the safety of weekly administration of Decoy20 in approximately 54 to 90 subjects. More than one dose may be studied in Part 2 that is at or below the MTD determined in Part 1. Eligible subjects must have one of the following locally advanced or metastatic tumor types: hepatocellular carcinoma (HCC), colorectal cancer (CRC) with liver metastasis, urothelial cancer, squamous cell carcinoma of the head and neck (SCCHN), adenocarcinoma of the pancreas, non-small cell lung cancer (NSCLC). Part 2 is further divided into 3 parts a Safety Run-In (Part 2a), a Dose Expansion (Part 2b) and a Combination with a PD-1 inhibitor, tislelizumab (Part 2c).

Part 2a enrolls 6 subjects in a staggered manner, and each subject receives 4 weekly doses of Decoy20 identified in Part 1. Safety data for each of these subjects is collected for 4 weeks after the subjects' 4th Decoy20 dose for acute and delayed toxicity. This data is reviewed by the SRC and a determination of one or more tolerable doses of Decoy20 for Part 2b is made.

Part 2b further evaluates and confirms the safety and preliminary efficacy of continuous weekly Decoy20 administration for up to 1 year. The SRC continues to meet and reviews data on an ongoing or ad-hoc basis during Part 2b of the study to ensure that there are no undue risks to study subjects and to confirm one or more tolerable doses for Phase 2.

Part 2c will evaluate the safety and tolerability of Decoy20 in combination with tislelizumab. The SRC will continue to meet and review data on an ongoing or ad-hoc basis during Part 2c of the study to ensure that there are no undue risks to study subjects and to confirm one or more tolerable Phase 2 doses and sequencing.

Being tested
Decoy20, Tislelizumab
Medical subject headings
Carcinoma, Hepatocellular, Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Decoy20Drug

    Decoy20 is a novel, systemically administered multiple Toll-like receptor (TLR) agonist-based cancer immunotherapy.

  • TislelizumabDrug

    Tislelizumab is a PD-1 inhibitor.

Study groups in NCT05651022
Study groupRoleWhat they receive
Part 1ExperimentalA single dose of Decoy20 at a dose of 3 x 10^7 KB or 7 x 10^7 KB
Receives: Drug: Decoy20
Parts 2a and 2bExperimentalDecoy20 administered weekly at a dose of 3 x 10^7 KB or 7 x 10^7 KB
Receives: Drug: Decoy20
Part 2cExperimentalDecoy20 administered weekly at either 3 x 10^7 KB or 7 x 10^7 KB. Both will be administered with tislelizumab at 200mg Q3W.
Receives: Drug: Decoy20; Drug: Tislelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Subjects with dose-limiting toxicities (DLTs)

    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.

    Measured: Through study completion, up to 3 years

  2. Percentage of subjects with Adverse Events (AEs)

    The count and percentage of subjects with AEs and Treatment Emergent Adverse Events (TEAEs) will be assessed for all subjects.

    Measured: Through completion, up to 3 years

  3. Maximum Tolerated Dose (MTD) of Decoy20

    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.

    Measured: Up to 2 years

  4. Recommended Phase 2 Dose (RP2D) of Decoy20

    The highest dose level that is declared to be safe and tolerable by the investigators and the sponsor.

    Measured: Up to 2.5 years

Secondary outcomes (7)

  1. Anti-Drug Antibodies (ADA)

    The incidence of ADAs will be assessed.

    Measured: Up to 3 years

  2. Neutralizing Antibodies (NAbs)

    The incidence of antibodies neutralizing Decoy20 will be assessed

    Measured: Up to 3 years

  3. Maximum drug concentration (Cmax) of Decoy20

    The blood pharmacokinetic parameter, Cmax, will be assessed pre-dose and up to 28 days post-dose after administration of Decoy20.

    Measured: Up to 3 years

  4. Area under the concentration versus time curve (AUC) of Decoy20

    The blood pharmacokinetic parameter, AUC, will be assessed pre-dose and up to 28 days post-dose after administration of Decoy20.

    Measured: Up to 3 years

  5. Elimination half-life (t1/2) of Decoy20

    The blood pharmacokinetic parameter, t1/2, will be assessed pre-dose and up to 28 days post-dose after administration of Decoy20.

    Measured: Up to 3 years

  6. Objective Response Rate (ORR)

    ORR is defined as the proportion of subjects achieving a best overall response of confirmed Partial Response (PR) or Complete Response (CR), per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

    Measured: Up to 3 years

  7. Duration of Response (DoR)

    DoR is defined as the duration of time from date of first response to date of disease progression, as per RECIST v1.1

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2022
  2. Study start28 Feb 2023
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Subjects received a single dose of Decoy20 at one of two assigned dose levels on Week 1 Day 1. Subjects were observed for 28 days for dose-limiting toxicity in the single ascending dose Part 1. Subjects enrolled in Part 2a and 2b receive continuous weekly doses of Decoy20 as monotherapy at the dose(s) determined from Part 1. Subjects enrolled in Part 2c will receive continuous weekly doses of Decoy20 at the dose(s) determined from Part 2a in combination with tislelizumab at its approved dose and schedule. Safety and preliminary anti-tumor activity will be assessed.
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05651022
Sponsor's protocol ID
INDP-D101
Status last verified
Jan 2026
First submitted
18 Nov 2022
Last updated
13 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Newman MJ. Invention and characterization of a systemically administered, attenuated and killed bacteria-based multiple immune receptor agonist for anti-tumor immunotherapy. Front Immunol. 2024 Nov 7;15:1462221. doi: 10.3389/fimmu.2024.1462221. eCollection 2024.

    PubMed 39606250

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Decoy20 and Tislelizumab in people with Solid Tumor, Adult and HCC - Hepatocellular Carcinoma, run by Indaptus Therapeutics, Inc at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects with dose-limiting toxicities (DLTs) (time frame: Through study completion, up to 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05651022, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.

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