The 1100 study is an open-label, Phase I, prospective clinical study to assess the safety of
intratumoral injection of NBTXR3 activated by radiotherapy in combination with anti-PD-1
therapy.
The 1100 study aims to evaluate the safety, efficacy, and tolerability of NBTXR3 activated by
radiotherapy in combination with an anti-PD-1 therapy in three cohorts of patients. The first
cohort includes patients with LRR or R/M HNSCC with the target lesion in a previously
irradiated field. In cohorts two and three, patients present with lung or liver metastases
from any primary cancer eligible for anti-PD-1 therapy. These patients have a high unmet need
and the Sponsor hypothesizes that NBTXR3 activated by radiotherapy will act synergistically
with anti-PD-1 to enhance the therapeutic index of radiotherapy maximizing local effect, to
overcome radio-resistance, to increase the local efficacy of immunotherapy, and to improve
distant tumor control via an abscopal effect. Eligible patients will receive a single
intratumoral injection of NBTXR3 subsequently activated by radiotherapy and then an approved
anti-PD-1. The end of treatment visit will take place 4 weeks after the last radiotherapy
fraction. Patients will be followed for long-term safety and efficacy until the end of the
study.
Inclusion Criteria:
- Signed informed consent form
- Biopsy-confirmed cancer diagnosis indicated to received anti-PD-1 therapy
- Has not received prior anti-PD-1 therapy (i.e., anti-PD-1 naïve) or is currently
receiving anti-PD-1 therapy and can be considered an anti-PD-1 non-responder (per SITC
guidelines)
- 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
Exclusion Criteria:
- History of severe immune-related adverse events related to administration of anti-PD-1
- Symptomatic central nervous system metastases and/or carcinomatous meningitis
- Active autoimmune disease that has required systemic treatment in the past 2 years
- Known HIV or active hepatitis B/C infection
- Active infection requiring systemic treatment
- 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 considered to be unamenable for radiation
treatment
- Locoregional recurrent HNSCC with ulceration
- Has received prior therapy with a checkpoint inhibitor, within 4 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
