Recruiting
Phase 1

NG-350A & CRT

Sponsor:

Akamis Bio

Code:

NCT06459869

Conditions

Locally Advanced Rectal Cancer (LARC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NG-350A IV administration

Capecitabine oral administration

Radiotherapy

Study Details

Brief summary:

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.

Conditions

Locally Advanced Rectal Cancer (LARC)

Study ID

NCT06459869

Start date

Apr 7, 2025

Status verified date

Aug, 2025

Completion date

Dec 30, 2028

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Selected Inclusion 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.

Selected Exclusion Criteria:

  • 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.

URL:

https://www.FortressStudy.org

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NG-350A plus CRT during a 12-week active study treatment period

Interventions

NG-350A IV administration

a tumour-selective anti-CD40-expressing adenoviral vector

Capecitabine oral administration

chemotherapy

Radiotherapy

long-course intensity-modulated radiotherapy

Primary outcome measure

  • Proportion of patients achieving a response (ncCR / cCR) [ Time Frame: 12 weeks after initiating NG-350A in combination with chemoradiotherapy (CRT) ]

Central Contacts and Locations

Central contacts

Vice President Head of Clinical Operations

+1 (484) 362-8918robert.maietta@akamisbio.com

https://www.FortressStudy.org

oliver.rosen@akamisbio.com

Locations

AdventHealth Orlando

Recruiting

Orlando, Florida, United States, 32804

Principal Investigator:

Mohamedtaki Tejani

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Principal Investigator:

Moh'd Khushman

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Principal Investigator:

Eric Miller

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Sonal Noticewala

More Information

Sponsor

Akamis Bio

Last update posted

Jun 12, 2026

Last verified

Aug, 2025

Keywords

  • Treatment naive
  • Oligometastatic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Akamis Bio on 2026-06-12.