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

  • STATUS
    Recruiting
  • End date
    Mar 30, 2023
  • participants needed
    60
  • sponsor
    Nanobiotix
Updated on 5 February 2021
cancer
nbtxr3

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.

Description

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.

Details
Condition Radiation Oncology, Neuroendocrine carcinoma, Radiotherapy, radiotherapeutic, Squamous cell carcinoma, Merkel cell carcinoma, head and neck cancer, Immunotherapy, Squamous Cell Carcinoma of the Head and Neck, Squamous Cell Carcinoma of Head and Neck, Metastatic Squamous Cell Carcinoma, Microsatellite Instability-High Solid Malignant Tumour, Metastasis From Malignant Tumor of Stomach (Disorder), Metastasis From Malignant Tumor of Cervix, Metastasis From Malignant Melanoma of Skin (Disorder), Metastasis From Malignant Tumor of Lung, Metastasis From Malignant Tumor of Bladder (Disorder), Microsatellite Instability-High Solid Malignant Tumour, Metastasis From Malignant Tumor of Stomach (Disorder), Metastasis From Malignant Melanoma of Skin (Disorder), Metastasis From Malignant Tumor of Bladder (Disorder), Microsatellite Instability-High Solid Malignant Tumour, Metastasis From Malignant Tumor of Stomach (Disorder), Metastasis From Malignant Melanoma of Skin (Disorder), Metastasis From Malignant Tumor of Bladder (Disorder), immunotherapies, Microsatellite Instability-High Solid Malignant Tumour, Metastasis From Malignant Tumor of Stomach (Disorder), Metastasis From Malignant Melanoma of Skin (Disorder), Metastasis From Malignant Tumor of Bladder (Disorder), Microsatellite Instability-High Solid Malignant Tumour, Metastasis From Malignant Tumor of Stomach (Disorder), Metastasis From Malignant Melanoma of Skin (Disorder), Metastasis From Malignant Tumor of Bladder (Disorder)
Treatment NBTXR3
Clinical Study IdentifierNCT03589339
SponsorNanobiotix
Last Modified on5 February 2021

Eligibility

Yes No Not Sure

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 nave) 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
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