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

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

INTRODUCTION

  • Org Study ID: 1100
  • Secondary ID: N/A
  • NTC ID: NCT03589339
  • Sponsor: Nanobiotix

BRIEF 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.

DETAILED 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.

  • Overall Status
    Recruiting
  • Start Date
    January 16, 2019
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Determination of the Recommended Dose

Primary Outcome 1 - Timeframe: 24 Months

CONDITION

  • Radiotherapy
  • Immunotherapy
  • Microsatellite Instability-High Solid Malignant Tumour
  • Metastasis From Malignant Tumor of Stomach (Disorder)
  • Squamous Cell Carcinoma of Head and Neck
  • Metastasis From Malignant Tumor of Cervix
  • Metastatic Squamous Cell Carcinoma
  • Metastasis From Malignant Melanoma of Skin (Disorder)
  • Merkel Cell Carcinoma (Disorder)
  • Metastasis From Malignant Tumor of Lung
  • Metastasis From Malignant Tumor of Bladder (Disorder)

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Elsa Borghi, MD

Role: Study Director

Affiliation: Nanobiotix

Overall Contact

Name: Elsa Borghi, MD

Phone: +1 (650) 796-9568, +1 (617) 460-6609

Email: katherine.jameson@nanobiotix.com, rodney.carter@nanobiotix.com

LOCATION

Facility Status Contact
Facility: Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
United States
Status: Recruiting Contact: Contact
Jiaxin Niu, MD, PhD

Facility: The University of Arizona Cancer Center
Tucson, Arizona 85719
United States
Status: Recruiting Contact: Contact
Monstaser Shaheen, MD

Facility: Christiana Care Health Services
Newark, Delaware 19713
United States
Status: Recruiting Contact: Contact
Michael Gaurino, MD

Facility: Moffitt Cancer Center
Tampa, Florida 33612
United States
Status: Recruiting Contact: Contact
Jessica Frakes, MD

Facility: University of Chicago Medical Center
Chicago, Illinois 60637
United States
Status: Recruiting Contact: Contact
Ari Rosenberg, MD

Facility: University of Louisville, James Graham Brown Cancer Center
Louisville, Kentucky 40202
United States
Status: Recruiting Contact: Contact
Rebecca Redman, MD

Facility: Johns Hopkins University, Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland 21287
United States
Status: Recruiting Contact: Contact
Tanguy Seiwert, MD

Facility: Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Status: Recruiting Contact: Contact
Theodore Hong, MD

Facility: Quantum Santa Fe
Santa Fe, New Mexico 87505
United States
Status: Recruiting Contact: Contact
Olivier Rixe, MD

Facility: University of North Carolina, School of Medicine
Chapel Hill, North Carolina 27516
United States
Status: Recruiting Contact: Contact
Colette Shen, MD, PhD