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

• Status: Recruiting
• Trial end date: 2023-03-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanobiotix
• Treatments: Antibodies

Criteria

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