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New treatment option for Advanced Malignant Solid Neoplasm
Official title Phase I/II Randomized Study of NBTXR3 Activated by Abscopal or RadScopal Radiation in Combination With Immunotherapy (Anti-PD-1/L-1) for Patients With Advanced Solid Malignancies
ClinicalTrials.gov ID: NCT05039632
What this study is testing
- What it's testing
- This phase I/II trial studies the side effects and possible benefits of NBTXR3, radiation therapy, Anti PD-1 / PD-L1 in treating patients with solid tumor that has spread to the lung (lung metastases) and/or liver (liver metastases). NBTXR3 may help make tumor cells more sensitive to the radiation therapy.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
- Which group you join is decided by chance.
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
- Patients with metastatic disease in the lung and/or liver, or soft tissue from any primary malignancy considered incurable by local therapies. a. One...
- The target lesion(s) must be measurable as per irRECIST and repeated measurements at the same anatomical location should be achievable. a...
- Amenable to undergo the image guided (EBUS or CT or MRI) intratumoral injection of NBTXR3, in up to two (2) high dose target lesions, as determined...
- Selected high and low dose target lesions must be amenable to receive radiation therapy as determined by the investigator or treating radiation...
- Allowed high dose RT regimens are 50 Gy in 4 fractions or 60 Gy in 10 fractions
You likely can't join if
- Prior radiation therapy received to the selected high dose target lesion(s) a. Previous radiation to low dose target lesions allowed as per...
- Symptomatic central nervous system metastases and/or carcinomatous meningitis a. Participants with previously treated brain metastases may...
- At screening, past medical history of:
- Interstitial lung disease
- Unresolved organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia)
- Any Grade 4 radiation toxicity
See the full eligibility criteria
Who can join
- Patients with metastatic disease in the lung and/or liver, or soft tissue from any primary malignancy considered incurable by local therapies. a. One prior anti-PD-1/L1 therapy allowed.
- The target lesion(s) must be measurable as per irRECIST and repeated measurements at the same anatomical location should be achievable. a. Participant must have at least 2 measurable lesions at screening. i. Abscopal...
- Amenable to undergo the image guided (EBUS or CT or MRI) intratumoral injection of NBTXR3, in up to two (2) high dose target lesions, as determined by the investigator or treating physician at screening. a. Intratumoral...
- Selected high and low dose target lesions must be amenable to receive radiation therapy as determined by the investigator or treating radiation oncologist.
- Allowed high dose RT regimens are 50 Gy in 4 fractions or 60 Gy in 10 fractions
- Allowed low dose RT for RadScopal™ cohort is 1.4 Gy per fraction for 4 - 5 fractions to only low dose-target lesion(s) determined by the investigator or treating physician.
- Patients can receive radiation therapy for symptomatic metastatic disease prior to enrollment or during the study a.
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Laboratory Values at screening:
- Hemoglobin ≥ 9.0 g/dL
- Absolute Neutrophil Count (ANC) ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
- Leukocytes ≥ 1500/mm3
- Creatinine ≤ 1.5 x upper limit of normal (ULN)
- Calc. creatinine clearance \> 30mL/min
- Total bilirubin ≤ 2.0 mg/dL
- AST / ALT ≤ 2.0 x upper limit of normal (ULN) or ≤ 3 x ULN for patients with liver metastases
- For participants to be treated for lung metastases, adequate lung function with expiratory volume in 1 second (FEV1) ≥ 0.8L or ≥ 35% predicted and carbon monoxide diffusing capability (DLCO) ≥ 40% with or without...
- Patients who meet the criterion above without oxygen (02), but need acute (started within 7 ± 3 days) supplemental oxygen due to tumor-caused obstruction/hypoxia are eligible, provided the amount of the O2 needed has...
- Negative urine or serum pregnancy test ≤ 7 days prior to NBTXR3 injection in all women of child-bearing potential (WOCBP). WOCBP must agree to follow instructions for method(s) of contraception for the duration the...
- Signed informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study. 4.2
What rules you out
- Prior radiation therapy received to the selected high dose target lesion(s) a. Previous radiation to low dose target lesions allowed as per investigator or treating radiation oncologist discretion.
- Symptomatic central nervous system metastases and/or carcinomatous meningitis a. Participants with previously treated brain metastases may participate if those lesions are radiologically stable (i.e., without evidence...
- At screening, past medical history of:
- Interstitial lung disease
- Unresolved organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia)
- Any Grade 4 radiation toxicity
- Unresolved, radiation or ICI related i. Pneumonitis ii. Bronchopulmonary hemorrhage iii. Abdominal hemorrhage e. Unresolved GI related events i. Diverticulitis ii. Colitis iii. Intra-abdominal abscess iv. GI...
- History of severe (Grade ≥ 3) immune-related adverse events observed with previous immunotherapy (anti-PD-1/L1) or known sensitivity (Grade ≥ 3) to any excipients.
- Has received any approved or investigational anti-neoplastic agent or immunotherapy within 2 weeks prior to NBTXR3 injection.
- Except anti-PD-1/L1, which will not require a washout window.
- A reduced washout window may be considered for therapies with short half-lives (i.e., kinase inhibitors) after discussion with Nanobiotix and investigator.
- Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). a. Replacement therapy (i.e., thyroxine...
- Any live-virus vaccine used for prevention of infectious diseases administered within 4 weeks prior to NBTXR3 injection.
- Except killed-virus Influenza vaccine
- Exception of other vaccines (e.g. pneumonia) is at the discretion of the treating physician after conducting a personalized risk assessment on a case by case basis.
- Prior allogenic stem cell transplantation or organ allograft.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia, or psychiatric illness...
- Known active, uncontrolled (high viral load) HIV or hepatitis B or hepatitis C infection.
- Female patients who are pregnant or breastfeeding.
- Women of child-bearing potential and their male partners who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and up to 160 days (\~5.33 months) for...
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
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 study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Houston, Texas, United States. 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.