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

  • Interventional
  • Recruiting
  • NCT03589339
Eligibility Details Visit Clinicaltrials.gov

A Phase I Study of NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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

         - 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

        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 more than one prior line of immunotherapy

         - 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 ontraception

         - Any condition for which participation would not be in the best interest of the participant

At a Glance

National Government IDNCT03589339

IRB#IRB18-0603

Lead SponsorNanobiotix

Lead PhysicianAri Joseph Rosenberg

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting