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Liver MetastasesPhase 1NCT04714983

DNX-2440 for Resectable Colorectal Liver Metastasis

A Phase 1 study testing DNX-2440 in people with Liver Metastases and Liver Metastasis Colon Cancer, run by DNAtrix, Inc. at 1 site in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

The purpose of this study is to test an experimental oncolytic adenovirus called DNX-2440 in patients with resectable multifocal (≥ 2 lesions) liver metastasis, who are scheduled to have curative-intent liver resection surgery. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
DNX-2440
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
15 Feb 2021to 31 Dec 2026
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Male or female aged ≥ 18 years at time of consent
  • Diagnosis of liver metastases from colorectal, breast, gastric, periampullary, melanoma, renal cell cancer, sarcoma, squamous cell carcinoma or gastrointestinal stromal tumor
  • Multiple (≥ 2) liver tumors
  • Candidate for curative-intent surgery
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Candidates eligible for targeted therapy, as per standard of care guidelines (and based on mutational status as indicated), must have completed therapy
  • Preoperative chemotherapy is allowed

Who cannot join

  • Recurrence of liver metastasis
  • Diagnosis of neuroendocrine tumor liver metastasis
  • Liver metastasis treated with > 12 cycles of systemic chemotherapy
  • Condition that requires ongoing systemic immunosuppressive therapy
  • Evidence of inadequate organ function based on lab parameters
  • Liver transaminases (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT]) or total bilirubin > 5x the upper limits of normal
  • Males or females who refuse to use a double-barrier form of birth control during the study and for up to 6 months after injection with DNX-2440

Trial locations and contacts

1 site in 1 country.

United States1 site

  • H. Lee Moffitt Cancer Center and Research Institute, Inc.

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase I Safety and Window-of-opportunity Study of Preoperative Intratumoral Injection of OX40-ligand Expressing Oncolytic Adenovirus (DNX-2440) in Patients With Resectable Liver Metastasis

The purpose of this study is to test an experimental oncolytic adenovirus called DNX-2440 in patients with resectable multifocal (≥ 2 lesions) liver metastasis, who are scheduled to have curative-intent liver resection surgery. Up to 18 patients will receive two sequential intra-tumoral injections of DNX-2440 into a metastatic liver tumor prior to surgery for liver resection, to evaluate safety and biological endpoints across 3 dose levels (dose escalation). Upon conclusion of the dose-escalation phase, the selected safe and biologically appropriate dose will be administered using the same schema for an additional 12 patients with colorectal cancer liver metastasis (expansion cohort) using established biologic endpoints.

Being tested
DNX-2440
Medical subject headings
Colorectal Neoplasms, Breast Neoplasms, Stomach Neoplasms, Melanoma, Carcinoma, Renal Cell, Sarcoma, Carcinoma, Squamous Cell, Gastrointestinal Stromal Tumors

What participants receive

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

  • DNX-2440Biological

    DNX-2440 is a replication competent oncolytic adenovirus expressing human OX40 ligand.

Study groups in NCT04714983
Study groupRoleWhat they receive
Dose-level 1ExperimentalThe dose-level 1 arm will use a 3+3 design. A single dose of DNX-2440 will be delivered via intra-tumoral injection at Visit 1 and at Visit 3 (2 administrations in total) approximately 14 days apart.
Receives: Biological: DNX-2440
Dose-level 2ExperimentalThe dose-level 2 arm will use a 3+3 design. A single dose of DNX-2440 will be delivered via intra-tumoral injection at Visit 1 and at Visit 3 (2 administrations in total) approximately 14 days apart.
Receives: Biological: DNX-2440
Dose-level 3ExperimentalThe dose-level 3 arm will use a 3+3 design. A single dose of DNX-2440 will be delivered via intra-tumoral injection at Visit 1 and at Visit 3 (2 administrations in total) approximately 14 days apart.
Receives: Biological: DNX-2440

What is being measured

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

  1. Maximum tolerated dose (MTD) achieved during dose-escalation phase

    The MTD will be defined as the highest tolerated dose below the dose that results in greater than or equal to one-third of the subjects exposed who experience a dose-limiting toxicity (DLT).

    Measured: 1.5 Years

Secondary outcomes (5)

  1. Efficacy of DNX-2440 assessed by Tumor Regression Grade (TRG) score

    Efficacy in tumor cell killing will be measured using the TRG score (1-5) for the resected specimens

    Measured: 3 Years

  2. Viral replication

    Viral replication will be assessed by quantitative measurement of viral protein expression by IHC

    Measured: 3 Years

  3. Measure Immune response with cell response panels

    Immunotherapeutic responses will be assessed by examining features and measuring changes following the intervention for Immunologic microenvironment (T-cell and Myeloid-cell response panels-tissue).

    Measured: 3 Years

  4. Measure Immune response with ImmunoSEQsec

    Immunotherapeutic responses will be assessed by measuring changes in T-cell receptor (TCR) repertoire - tissue and blood.

    Measured: 3 Years

  5. Measure Immune response with ELISPOT

    Immunotherapeutic responses will be assessed by measuring T-cell response (ELISPOT - tissue/blood).

    Measured: 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 posted20 Jan 2021
  2. Study start15 Feb 2021
  3. Primary completion31 Jul 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Why it stopped: DNAtrix management decision not based on study design, safety, or site performance.

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04714983
Sponsor's protocol ID
2440LM-002
Status last verified
Apr 2024
First submitted
9 Dec 2020
Last updated
9 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DNX-2440 in people with Liver Metastases and Liver Metastasis Colon Cancer, run by DNAtrix, Inc. at 1 site 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 7 inclusion and 7 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: paused, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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.

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

Are results available for this study?

Results are not available in the source record.

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?

Maximum tolerated dose (MTD) achieved during dose-escalation phase (time frame: 1.5 Years). 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 NCT04714983.

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 9 Apr 2024.

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