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

Trial Status: Active

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.

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

Arizona

Tucson
Banner University Medical Center - Tucson
Status: ACTIVE

Florida

Tampa
Moffitt Cancer Center
Status: ACTIVE

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: ACTIVE

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE

Massachusetts

Boston
Massachusetts General Hospital Cancer Center
Status: ACTIVE

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL_AND_INTERVENTION

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.

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Nanobiotix

  • Primary ID 1100
  • Secondary IDs NCI-2019-03108, NBTXR3-1100
  • Clinicaltrials.gov ID NCT03589339