NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy

Running, not enrolling · Phase 1

Conditions studied: Radiotherapy, Immunotherapy, Microsatellite Instability-High Solid Malignant Tumour, Metastasis From Malignant Tumor of Liver, Squamous Cell Carcinoma of Head and Neck, Metastasis From Malignant Tumor of Cervix, Metastatic Renal Cell Carcinoma, Metastasis From Malignant Melanoma of Skin (Disorder), Metastatic Triple-Negative Breast Carcinoma, Metastatic NSCLC, Metastasis From Malignant Tumor of Bladder (Disorder)

In brief

The 1100 study is an open-label, Phase I, dose escalation and expansion prospective clinical study to assess the safety of intratumoral injection of NBTXR3 activated by radiotherapy in combination with anti-PD-1 therapy.

Key facts

Study ID: NCT03589339
Run by: Nanobiotix
People needed: 145
Starts: 2019-01-16
Expected to finish: 2027-08-30
Last updated by the study team: 2025-10-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Signed informed consent form
Biopsy-confirmed cancer diagnosis indicated to receive anti-PD-1 therapy:
Dose Escalation:
Escalation Cohort 1: Is inoperable LRR with tumor in previously irradiated HN field that is amenable to re-irradiation or R/M HNSCC with tumor in previously irradiated HN field that is amenable to re-irradiation, or
Escalation Cohort 2: Has metastasized to the lung (including involved lymph nodes) with tumor in a previously non-irradiated lung field, or
Escalation Cohort 3: Has metastasized to the liver with tumor in a previously non-irradiated liver field
Expansion:
Expansion Cohorts 1 and 2: Is inoperable LRR or R/M HNSCC with at least one lesion that is amenable to irradiation within head and neck region, lung or liver
Expansion Cohort 3: Is inoperable NSCLC, malignant melanoma, HCC, RCC, urothelial cancer, cervical cancer, TNBC that has metastasized to soft tissues, lung (including mediastinal lymph nodes) or liver with at least one lesion that is amenable to irradiation
Prior anti-PD-1 exposure as follows:
Dose Escalation (all cohorts):
Has not received prior anti-PD-1 therapy (i.e., anti-PD-1 naïve), or
Has received prior anti-PD-1 therapy and meets criteria consistent with anti-PD-1 primary resistance (i.e., primary anti-PD-1 non-responder), or
Has received prior anti-PD-1 therapy and meets criteria consistent with anti-PD-1 secondary resistance (i.e., secondary anti-PD-1 non-responder)
Expansion:
Expansion Cohorts 1 and 3: Has received prior anti-PD-1 therapy and meets criteria consistent with anti-PD-1 primary or secondary resistance as described above
Expansion Cohort 2: Has not received prior anti-PD-1 therapy (i.e., anti-PD-1 naïve)
Has at least one tumor lesion that can be accurately measured according to RECIST 1.1. and is amenable for intratumoral injection
ECOG performance status 0-2
Life expectancy >12 weeks
Adequate organ and bone marrow function
Negative pregnancy test ≤ 7 days prior to NBTXR3 injection in all female participants of child-bearing potential

You may not qualify if…

History of immune-related adverse events related to administration of anti-PD-1/L1 that led to the termination of the previous anti-PD-1 therapy due to intolerance or toxicity and precludes further PD-1 exposure
Symptomatic central nervous system metastases and/or carcinomatous meningitis
Active autoimmune disease that has required systemic treatment in the past 1 year
Known HIV or active hepatitis B/C infection
Active infection requiring intravenous treatment with antibiotics
Received a live virus vaccine within 30 days prior to study treatment
History of pneumonitis that required steroids or with current pneumonitis
Extensive metastatic disease burden defined as more than 5 lesions overall including the primary tumor
Locoregional recurrent HNSCC with ulceration
Has received prior therapy with a checkpoint inhibitor, within 2 weeks prior to NBTXR3 injection
Has received prior systemic anti-neoplastic therapy, including investigational agents, within 4 weeks prior to NBTXR3 injection
Has not recovered from AEs due to previous anti-neoplastic therapies and/or interventions (including radiation) to ≤ Grade 1 or baseline at screening
Clinically significant cardiac arrhythmias
Class III or IV Congestive Heart Failure as defined by the New York Heart Association functional classification system < 6 months prior to screening
A pregnant or nursing female, or women of child-bearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Any condition for which participation would not be in the best interest of the participant

Where it is running

University of California San Francisco — San Francisco, California, United States
Moffitt Cancer Center — Tampa, Florida, United States
Emory University — Atlanta, Georgia, United States
University of Chicago Medical Center — Chicago, Illinois, United States
Johns Hopkins University, Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
Karmanos Cancer Institute — Detroit, Michigan, United States
Henry Ford Cancer Institute — Detroit, Michigan, United States
Christus St. Vincent Regional Cancer Center — Santa Fe, New Mexico, United States
Northwell Health — Manhasset, New York, United States
University of North Carolina, School of Medicine — Chapel Hill, North Carolina, United States
Gabrail Cancer Center — Canton, Ohio, United States
St Luke's University Health Network — Bethlehem, Pennsylvania, United States
Sanford Cancer Center — Sioux Falls, South Dakota, United States

Full record on ClinicalTrials.gov

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