DNX-2440 for Resectable Colorectal Liver Metastasis

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    30
  • sponsor
    DNAtrix, Inc.
Updated on 19 April 2022
cancer
carcinoma
squamous cell carcinoma
metastasis
liver metastasis
chemotherapy regimen
cancer chemotherapy
targeted therapy
gastrointestinal stromal tumor
stromal tumor

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. 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.

Details
Condition Liver Metastases, Liver Metastasis Colon Cancer, Colorectal Cancer, Breast Cancer, Gastric Cancer, Periampullary Cancer, Melanoma, Renal Cell Cancer, Sarcoma, Squamous Cell Carcinoma, Gastrointestinal Stromal Tumors
Treatment DNX-2440
Clinical Study IdentifierNCT04714983
SponsorDNAtrix, Inc.
Last Modified on19 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note