NG-350A with Chemoradiotherapy for Locally Advanced Rectal Cancer
This study is looking at a new way to treat locally advanced rectal cancer. It combines a drug called NG-350A, which is given through an IV, with standard chemotherapy (Capecitabine taken by mouth) and radiation therapy. The goal is to see how many patients have a good response to this combination treatment. You might be able to join if you are an adult with locally advanced rectal cancer that a team of doctors has decided needs this type of treatment before surgery. The study plans to enroll 30 people, but its current recruitment status is unclear.
- Study design
- This is an open-label, single-arm study, meaning everyone receives the same treatment and both you and your doctors will know what treatment you are getting. It plans to include 30 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main goal of the study is measured 12 weeks after starting the NG-350A and chemoradiotherapy combination.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06459869
NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentAkamis Bio
~30 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:NG-350A IV administrationCapecitabine oral administrationRadiotherapy
At a glance
Recruiting sites
6 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients achieving a response (ncCR / cCR)
Measured over 12 weeks after initiating NG-350A in combination with chemoradiotherapy (CRT)
Conditions
Where it's being run
7 sites across 6 statesUnited Kingdom2
California1
Florida1
Missouri1
Ohio1
Texas1
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
Exclusion
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.
What this trial measures
- Proportion of patients achieving a response (ncCR / cCR)12 weeks after initiating NG-350A in combination with chemoradiotherapy (CRT)