NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy
A Phase I Dose Escalation / Dose Expansion Study of NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy
1 other identifier
interventional
145
1 country
13
Brief Summary
The 1100 study is an open-label, Phase I, dose escalation and expansion prospective clinical study to assess the safety of intratumoral injection of NBTXR3 activated by radiotherapy in combination with anti-PD-1 therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2019
Longer than P75 for phase_1
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2018
CompletedFirst Posted
Study publicly available on registry
July 17, 2018
CompletedStudy Start
First participant enrolled
January 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 30, 2027
October 24, 2025
October 1, 2025
8.3 years
April 10, 2018
October 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
[Dose Escalation Part]: Determination of the Recommended Dose
Determination of DLTs, the MTD (if possible), and RP2Ds for each cohort
24 Months
[Dose Expansion Part]: Safety Evaluation at RP2D
Incidence of Grade 3 and higher treatment-related AEs
24 Months
Secondary Outcomes (3)
Evaluation of the anti-tumor response of R3/RT/PD-1
24 months
Assessment of the safety and feasibility of R3/RT/PD-1
24 months
Evaluation of the body kinetic profile of intratumorally injected NBTXR3
24 months
Study Arms (1)
NBTXR3 activated by SABR followed by anti-PD-1 monotherapy
EXPERIMENTALIntratumoral injection of NBTXR3 followed by SABR followed by monotherapy with nivolumab or pembrolizumab
Interventions
Radiotherapy given as a definite number of fractions at the dose defined for each radiation field
Anti-PD-1 monotherapy
Anti-PD-1 monotherapy
Eligibility Criteria
You may qualify if:
- Signed informed consent form
- Biopsy-confirmed cancer diagnosis indicated to receive anti-PD-1 therapy:
- Dose Escalation:
- Escalation Cohort 1: Is inoperable LRR with tumor in previously irradiated HN field that is amenable to re-irradiation or R/M HNSCC with tumor in previously irradiated HN field that is amenable to re-irradiation, or
- Escalation Cohort 2: Has metastasized to the lung (including involved lymph nodes) with tumor in a previously non-irradiated lung field, or
- Escalation Cohort 3: Has metastasized to the liver with tumor in a previously non-irradiated liver field
- Expansion:
- Expansion Cohorts 1 and 2: Is inoperable LRR or R/M HNSCC with at least one lesion that is amenable to irradiation within head and neck region, lung or liver
- Expansion Cohort 3: Is inoperable NSCLC, malignant melanoma, HCC, RCC, urothelial cancer, cervical cancer, TNBC that has metastasized to soft tissues, lung (including mediastinal lymph nodes) or liver with at least one lesion that is amenable to irradiation
- Prior anti-PD-1 exposure as follows:
- Dose Escalation (all cohorts):
- Has not received prior anti-PD-1 therapy (i.e., anti-PD-1 naïve), or
- Has received prior anti-PD-1 therapy and meets criteria consistent with anti-PD-1 primary resistance (i.e., primary anti-PD-1 non-responder), or
- Has received prior anti-PD-1 therapy and meets criteria consistent with anti-PD-1 secondary resistance (i.e., secondary anti-PD-1 non-responder)
- Expansion:
- +7 more criteria
You may not qualify if:
- History of immune-related adverse events related to administration of anti-PD-1/L1 that led to the termination of the previous anti-PD-1 therapy due to intolerance or toxicity and precludes further PD-1 exposure
- Symptomatic central nervous system metastases and/or carcinomatous meningitis
- Active autoimmune disease that has required systemic treatment in the past 1 year
- Known HIV or active hepatitis B/C infection
- Active infection requiring intravenous treatment with antibiotics
- 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 defined as more than 5 lesions overall including the primary tumor
- Locoregional recurrent HNSCC with ulceration
- Has received prior therapy with a checkpoint inhibitor, within 2 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nanobiotixlead
Study Sites (13)
University of California San Francisco
San Francisco, California, 94158, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Emory University
Atlanta, Georgia, 30308, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Johns Hopkins University, Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Henry Ford Cancer Institute
Detroit, Michigan, 48202, United States
Christus St. Vincent Regional Cancer Center
Santa Fe, New Mexico, 87505, United States
Northwell Health
Manhasset, New York, 11030, United States
University of North Carolina, School of Medicine
Chapel Hill, North Carolina, 27516, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
St Luke's University Health Network
Bethlehem, Pennsylvania, 18015, United States
Sanford Cancer Center
Sioux Falls, South Dakota, 57104, United States
Related Publications (1)
Shen C, Frakes J, Niu J, et al 684 NBTXR3 activated by radiotherapy in combination with nivolumab or pembrolizumab in patients with advanced cancers: results from an ongoing dose escalation phase I trial (Study 1100). Journal for ImmunoTherapy of Cancer 2022;10:doi: 10.1136/jitc-2022-SITC2022.0684
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pavel Tyan, MD
Nanobiotix
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2018
First Posted
July 17, 2018
Study Start
January 16, 2019
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
August 30, 2027
Last Updated
October 24, 2025
Record last verified: 2025-10