RECRUITING

NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The FORTRESS trial (NG-350A-03) is an open-label, single-arm, and multicentre trial of NG-350A in combination with chemoradiotherapy (CRT) in adult patients with locally advanced rectal cancer (LARC) and at least one risk factor for local or distant recurrence.

Official Title

A Multicentre, Open-label, Non-randomized, Phase 1b Trial of NG-350A, a Tumour-selective Anti-CD40-expressing Adenoviral Vector, in Combination With Chemoradiotherapy in Locally Advanced Rectal Cancer (FORTRESS)

Quick Facts

Study Start:2025-04-07

Study Completion:2029-01-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06459869

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Histologically confirmed adenocarcinoma of the rectum. * Locally advanced disease (clinical stage II-III based on pelvic MRI) selected by a multidisciplinary team for treatment with neoadjuvant CRT (which may be followed by CNCT to comprise planned TNT). Patients with oligometastatic disease are permitted provided that the site-specific multidisciplinary team deems them suitable for radical treatment/chemoradiation. * Confirmed microsatellite stable (MSS)/proficient mismatch repair (pMMR) status. * Provide written informed consent to participate. * ECOG Performance Status 0 or 1. * Must not be pregnant or breastfeeding. * Patients who are sexually active (with either sex) must agree to comply with contraceptive requirements. * Adequate lung reserve, renal function, hepatic function, and bone marrow/hematological function assessed ≤ 10 days prior to first dose.	* Recurrent rectal cancer. * Distant metastatic disease not amenable to radical treatment/chemoradiation. * Other prior malignancy active within the previous 3 years, except for local or organ confined early-stage cancer that has been definitively treated with curative intent, does not require ongoing treatment, has no evidence of residual disease, and has a negligible risk of recurrence and is therefore unlikely to interfere with the primary and secondary endpoints of the trial, including response rate and safety. * Splenectomy (patients with prior partial resection remain eligible if the Investigator considers splenic function to not be significantly compromised). * Active autoimmune disease that has required systemic therapy in the past 2 years, immunocompromised status in the opinion of the Investigator, or current treatment with systemic immunosuppressive therapy (daily prednisone equivalent for chronic system replacement not to exceed 10mg per day). * Infectious or inflammatory bowel disease in the 3 months before the first dose of study treatment. * Any clinically significant cardiovascular, peripheral vascular, cerebrovascular, or thromboembolic event in the last 1 month before the first dose of study treatment. * Major surgery in the 14 days before the first dose of study treatment or any surgical wounds that are not fully healed and free of infection or dehiscence. * Any prior surgery for rectal cancer or pelvic radiotherapy. * Any other anti-cancer or experimental therapy within the previous 12 months or that is planned during the active study treatment period. * Treatment with any other enadenotucirev-based virus (parent virus or transgene-modified variants), or anti-CD40 antibody at any time. * History of prior Grade 3-4 acute kidney injury or other clinically significant renal impairment. * Any ongoing Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 coagulation abnormality/coagulopathy.

Inclusion Criteria

Exclusion Criteria

* Histologically confirmed adenocarcinoma of the rectum.
* Locally advanced disease (clinical stage II-III based on pelvic MRI) selected by a multidisciplinary team for treatment with neoadjuvant CRT (which may be followed by CNCT to comprise planned TNT). Patients with oligometastatic disease are permitted provided that the site-specific multidisciplinary team deems them suitable for radical treatment/chemoradiation.
* Confirmed microsatellite stable (MSS)/proficient mismatch repair (pMMR) status.
* Provide written informed consent to participate.
* ECOG Performance Status 0 or 1.
* Must not be pregnant or breastfeeding.
* Patients who are sexually active (with either sex) must agree to comply with contraceptive requirements.
* Adequate lung reserve, renal function, hepatic function, and bone marrow/hematological function assessed ≤ 10 days prior to first dose.

* Recurrent rectal cancer.
* Distant metastatic disease not amenable to radical treatment/chemoradiation.
* Other prior malignancy active within the previous 3 years, except for local or organ confined early-stage cancer that has been definitively treated with curative intent, does not require ongoing treatment, has no evidence of residual disease, and has a negligible risk of recurrence and is therefore unlikely to interfere with the primary and secondary endpoints of the trial, including response rate and safety.
* Splenectomy (patients with prior partial resection remain eligible if the Investigator considers splenic function to not be significantly compromised).
* Active autoimmune disease that has required systemic therapy in the past 2 years, immunocompromised status in the opinion of the Investigator, or current treatment with systemic immunosuppressive therapy (daily prednisone equivalent for chronic system replacement not to exceed 10mg per day).
* Infectious or inflammatory bowel disease in the 3 months before the first dose of study treatment.
* Any clinically significant cardiovascular, peripheral vascular, cerebrovascular, or thromboembolic event in the last 1 month before the first dose of study treatment.
* Major surgery in the 14 days before the first dose of study treatment or any surgical wounds that are not fully healed and free of infection or dehiscence.
* Any prior surgery for rectal cancer or pelvic radiotherapy.
* Any other anti-cancer or experimental therapy within the previous 12 months or that is planned during the active study treatment period.
* Treatment with any other enadenotucirev-based virus (parent virus or transgene-modified variants), or anti-CD40 antibody at any time.
* History of prior Grade 3-4 acute kidney injury or other clinically significant renal impairment.
* Any ongoing Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 coagulation abnormality/coagulopathy.

Contacts and Locations

Study Contact

Vice President Head of Clinical Operations

CONTACT

+1 (484) 362-8918

robert.maietta@akamisbio.com

Study Locations (Sites)

University of California Los Angeles (UCLA)

Santa Monica, California, 90404

United States

Ohio State University Comprehensive Cancer Center (OSU)

Columbus, Ohio, 43210

United States

The University of Texas MD Anderson Cnacer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Akamis Bio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-07

Study Completion Date2029-01-30

Study Record Updates

Study Start Date2025-04-07

Study Completion Date2029-01-30

Terms related to this study

Additional Relevant MeSH Terms

Locally Advanced Rectal Cancer (LARC)