BridgeMD
New treatment option for Locally Advanced Rectal Cancer (LARC)
Official title NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer
ClinicalTrials.gov ID: NCT06459869
What this study is testing
What is NG-350A IV administration?
NG-350A IV administration is an investigational medicine, being studied as a potential treatment for locally advanced rectal cancer (larc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Selected
- 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...
- Confirmed microsatellite stable (MSS)/proficient mismatch repair (pMMR) status.
- Provide written informed consent to participate.
You likely can't join if
- 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...
- Splenectomy (patients with prior partial resection remain eligible if the Investigator considers splenic function to not be significantly...
- Active autoimmune disease that has required systemic therapy in the past 2 years, immunocompromised status in the opinion of the Investigator, or...
- Infectious or inflammatory bowel disease in the 3 months before the first dose of study treatment.
See the full eligibility criteria
- Selected
- 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...
- 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Orlando, Florida, United States
- St Louis, Missouri, United States
- Columbus, Ohio, United States
- Houston, Texas, United States
- London, United Kingdom
- Sutton, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Orlando, Florida, United States; St Louis, Missouri, United States; Columbus, Ohio, United States; Houston, Texas, United States; London, United Kingdom and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.