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Trial record 3 of 8 for:    NBTXR3

NBTXR3 Activated by SABR for Patients With Advanced HNSCC or NSCLC Treated With an Anti-PD1 Antibody

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ClinicalTrials.gov Identifier: NCT03589339
Recruitment Status : Not yet recruiting
First Posted : July 17, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Nanobiotix

Brief Summary:
The study is an open label Phase I/II prospective clinical trial, non randomized, which consists of two consecutive steps, a dose escalation and a subsequent dose expansion part. The phase I and II parts include different patient population.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer NSCLC Radiotherapy Immunotherapy Drug: NBTXR3 Phase 1 Phase 2

Detailed Description:

Escalation dose part:

Elegible patients will receive a single intratumoral injection of NBTXR3 concurrently with an approved anti-PD1 and will receive external beam radiotherapy starting 24 hours after the injection up to completion of 15 days of treatment.

Expansion dose part:

Elegible patients will receive a single intratumoral injection of NBTXR3 concurrently with an approved anti-PD1 and will receive external beam radiotherapy starting 24 hours after the injection up to completion of 15 days of treatment at recommended NBTXR3 dose and recommended radiotherapy dose.

A visit of end of treatment will take place approximately 3-4 weeks after last radiotherapy fraction. Patients will be followed for evaluation of their disease status and adverse event until the end of the study.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of NBTXR3 Activated by SABR for Patients With Advanced HNSCC or NSCLC Treated With an Anti-PD1 Antibody
Estimated Study Start Date : September 21, 2018
Estimated Primary Completion Date : March 30, 2023
Estimated Study Completion Date : March 30, 2023

Arm Intervention/treatment
Experimental: NBTXR3 activated by SABR Drug: NBTXR3
Single intra Tumoral injection




Primary Outcome Measures :
  1. Phase1: Determination of the Maximum Tolerated Doses and the early Dose Limitting Toxicities (DLT) [ Time Frame: 24 months ]
    To determine the Maximum Tolerated Dose/s and the early Dose Limiting Toxicities (DLT) of intratumoral/intralesional injection of NBTXR3 activated by SABR in combination with an anti-PD1 antibody,

  2. Phase1: Determination of the Recommended Doses [ Time Frame: 24 months ]
    To determine the Recommended Dose/s of NBTXR3 given as intratumoral/Intralesional injection and activated by SABR in combination with an anti-PD1 antibody, in patients with: Locoregionally recurrent or metastatic HNSCC amenable to re-irradiation (RD1), Lung metastasis from HNSCC (not amenable to reirradiation if synchronous locoregional recurrence and metastasis) or NSCLC (not previously irradiated) (RD2), Liver metastasis from HNSCC (not amenable to reirradiation if synchronous locoregional recurrence and metastasis) or NSCLC (not previously irradiated) (RD3)

  3. Phase2: Complete Response rate by RECIST version 1.1 [ Time Frame: 24 months ]
    To measure by RECIST v1.1 the Complete Response rate.

  4. Phase2: Incidence of clinical and laboratory adverse events and serious adverse events [ Time Frame: 24 months ]
    To assess the incidence of clinical and laboratory adverse events and serious adverse events.


Secondary Outcome Measures :
  1. Phase1: Incidence of clinical and laboratory adverse events and serious adverse events [ Time Frame: 24 months ]
    To assess the incidence of clinical and laboratory adverse events and serious adverse events.

  2. Phase1: Late onset grade ≥ 3 NCI CTCAE adverse events [ Time Frame: 24 months ]
    To determine the late onset toxicity of NBTXR3 given as intratumoral/intralesional injection activated by SABR in combination with an anti-PD1 antibody. To assess the "late onset" grade ≥ 3 NCI CTCAE adverse events.

  3. Phase2: Body Kinetic characterization by quantification of Hafnium in whole blood and urine. [ Time Frame: 24 months ]
    To characterize the body kinetic profile by quantification of Hafnium at day 1 of NBTXR3 intratumoral/intralesional injection, activated by SABR in combination with an anti-PD1 antibody.Whole blood will be collected at the end of injection up to 4 hours post end injection. Urine sample will be collected twice after injection.

  4. Phase2: Tumor response assessment by RECIST version 1.1 and iRECIST criteria [ Time Frame: 24 months ]
    To assess tumor response by RECIST version 1.1 and iRECIST criteria



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18
  • Histologically-proven inoperable loco- regional recurrent HNSCC with tumor in previously irradiated Head Neck field which is amenable to re-irradiation with SABR
  • Histologically-proven recurrent AND metastatic HNSCC with tumor in previously irradiated Head Neck field which is amenable to re-irradiation with SABR
  • Histologically-proven lung metastasis, accessible to intratumoral injection, not previously irradiated, from HNSCC not amenable to re-irradiation if synchronous locoregional recurrence and metastasis, or from NSCLC (squamous and non squamous types),
  • Histologically-proven liver metastasis, accessible to intratumoral injection, not previously irradiated, from HNSCC not amenable to re-irradiation if synchronous locoregional recurrence and metastasis, or from NSCLC (squamous and non squamous types),
  • Known status of human papillomavirus infection, in patients with oropharyngeal SCC
  • HNSCC with prior irradiation, concurrent or not with platin-based chemotherapy or cetuximab
  • Non symptomatic CNS metastasis is elegible
  • NSCLC previously treated or not with a platinum based-regimen
  • Patients with NSCLC tumors with EGFR or ALK genomic aberrations must have had disease progression under approved molecular targeted therapy
  • Metastatic patients must have received an approved anti-PD1 with SD for at least for 12 weeks or with confirmed PD at 12 weeks
  • Karnofsky performance status ≥60
  • Life expectancy >12 weeks
  • Adequate function of bone marrow
  • Adequate liver function
  • Adequate kidney function:
  • Non-childbearing potential:

    • All female patients of childbearing potential must have a negative serum pregnancy test within the 7 days prior to NBTXR3 administration.
    • Female patients of childbearing potential must agree and use at least 2 forms of highly effective methods of contraception, including at least 1 barrier method starting with the first dose of study therapy through 150 days after the last dose of study therapy.
    • Male patients and their sexual partner(s) of childbearing potential must agree and use at least 2 forms of highly effective methods of contraception, including at least 1barrier method starting with the first dose of study therapy through 150 days after the last dose of study therapy.

Exclusion Criteria:

  • Written Informed Consent not obtained, signed and dated
  • Hypersensitivity to anti-PD1 monoclonal antibody
  • History of severe immune-related adverse event requiring treatment discontinuation
  • Diagnosis of immunodeficiency or receiving systemic steroid therapy in excess of physiologic dose within 7 days prior to treatment start
  • Active autoimmune disease requiring systemic treatment in the past year
  • History of non-infectious pneumonitis or HIV
  • Active hepatitis B or hepatitis C
  • Peripheral neuropathy >grade 2
  • Loco-regional recurrent HNSCC with ulceration
  • Target lung metastatic lesion <2 cm
  • Metastatic lesion not easily accessible for intratumoral/intralesional injection.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active severe infection, symptomatic congestive heartfailure, acute coronary syndrome, etc.
  • Medical history of life-threatening ventricular arrhythmia
  • Concurrent treatment with any other anticancer therapy not determined by the study treatment or planning to receive these treatments during the study
  • Patients unable to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures or those with severe psychiatric illness/social situations that would limit compliance with study requirements
  • Patients participating in another clinical investigation at the time of signature of the informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03589339


Contacts
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Contact: Andrzej Urban, MD PhD + 33 (1) 79 97 29 93 andrzej.urban@nanobiotix.com

Locations
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United States, Illinois
University of CHicago Medical Center Not yet recruiting
Chicago, Illinois, United States, 60637
Contact: Tanguy Seiwert, MD         
United States, North Carolina
University of North Carolina, School of Medicine Not yet recruiting
Chapel Hill, North Carolina, United States, 27516
Contact: Jared Weiss, MD         
Sponsors and Collaborators
Nanobiotix

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Responsible Party: Nanobiotix
ClinicalTrials.gov Identifier: NCT03589339     History of Changes
Other Study ID Numbers: NBTXR3-1100
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Antibodies
Immunologic Factors
Physiological Effects of Drugs