NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer

Trial Title: NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer

NCT ID: NCT06459869

Condition: Locally Advanced Rectal Cancer (LARC)

Conditions: Official terms:
Rectal Neoplasms
Capecitabine

Study type: Interventional

Study phase: Phase 1

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: NG-350A IV administration
Description: a tumour-selective anti-CD40-expressing adenoviral vector
Arm group label: NG-350A plus CRT during a 12-week active study treatment period

Intervention type: Drug
Intervention name: Capecitabine oral administration
Description: chemotherapy
Arm group label: NG-350A plus CRT during a 12-week active study treatment period

Intervention type: Radiation
Intervention name: Radiotherapy
Description: long-course intensity-modulated radiotherapy
Arm group label: NG-350A plus CRT during a 12-week active study treatment period

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: November 15, 2024

Completion date: January 30, 2029

Lead sponsor:
Agency: Akamis Bio
Agency class: Industry

Source: Akamis Bio

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06459869