RadiotherapyPhase 1NCT03589339
NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy
A Phase 1 study testing NBTXR3, SABR and Nivolumab in people with Radiotherapy and Immunotherapy, run by Nanobiotix at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiotherapy, Immunotherapy, Microsatellite Instability-High Solid Malignant Tumour
- What is being tested?
- NBTXR3, SABR and Nivolumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 13 sitesUnited States
- Study dates
- 16 Jan 2019to 30 Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 22Show fewer
- 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:
- Expansion Cohorts 1 and 3: Has received prior anti-PD-1 therapy and meets criteria consistent with anti-PD-1 primary or secondary resistance as described above
- Expansion Cohort 2: Has not received prior anti-PD-1 therapy (i.e., anti-PD-1 naïve)
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
- Any condition for which participation would not be in the best interest of the participant
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Emory University
Atlanta, Georgia, 30308
Johns Hopkins University, Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287
St Luke's University Health Network
Bethlehem, Pennsylvania, 18015
Gabrail Cancer Center
Canton, Ohio, 44718
University of North Carolina, School of Medicine
Chapel Hill, North Carolina, 27516
University of Chicago Medical Center
Chicago, Illinois, 60637
Karmanos Cancer Institute
Detroit, Michigan, 48201
Henry Ford Cancer Institute
Detroit, Michigan, 48202
Northwell Health
Manhasset, New York, 11030
University of California San Francisco
San Francisco, California, 94158
Christus St. Vincent Regional Cancer Center
Santa Fe, New Mexico, 87505
Sanford Cancer Center
Sioux Falls, South Dakota, 57104
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: 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
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.
Read the 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 in dose escalation and expansion parts. The Escalation Cohort 1 includes patients with LRR or R/M HNSCC with the injectable lesion in a previously irradiated field. In Escalation Cohorts 2 and 3, patients present with lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy.
The Expansion cohort 1 includes patients with LRR or R/M HNSCC with the injectable lesion located either in head and neck area or in lung or liver, who are resistant to anti-PD-1 therapy. The Expansion cohort 2 includes patients with LRR or R/M HNSCC with the injectable lesion located either in head and neck area or in lung or liver, who are naive to anti-PD-1 therapy.
The Expansion Cohort 3 includes patients with inoperable NSCLC, malignant melanoma, HCC, RCC, urothelial cancer, cervical cancer or TNBC with metastases to lungs, liver or soft tissue and who are resistant to 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 for 2 years after the EOT visit.
- Conditions
- Radiotherapy, Immunotherapy, Microsatellite Instability-High Solid Malignant Tumour, Metastasis From Malignant Tumor of Liver, Squamous Cell Carcinoma of Head and Neck, Metastasis From Malignant Tumor of Cervix
- Being tested
- NBTXR3, SABR, Nivolumab, Pembrolizumab
- Keywords
- Oral Cavity Cancer, Oropharynx Cancer, Lung Metastasis, Liver Metastasis
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Carcinoma, Renal Cell, Triple Negative Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Mouth Neoplasms, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBTXR3Drug
Single intra Tumoral injection
SABRRadiation
Also called Stereotaxic Ablative Radiotherapy, Stereotaxic Body Radiation Therapy
Radiotherapy given as a definite number of fractions at the dose defined for each radiation field
NivolumabDrug
Also called Opdivo
Anti-PD-1 monotherapy
PembrolizumabDrug
Also called Keytruda
Anti-PD-1 monotherapy
| Study group | Role | What they receive |
|---|---|---|
| NBTXR3 activated by SABR followed by anti-PD-1 monotherapy | Experimental | Intratumoral injection of NBTXR3 followed by SABR followed by monotherapy with nivolumab or pembrolizumab Receives: Drug: NBTXR3; Radiation: SABR; Drug: Nivolumab; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
[Dose Escalation Part]: Determination of the Recommended Dose
Determination of DLTs, the MTD (if possible), and RP2Ds for each cohort
Measured: 24 Months
[Dose Expansion Part]: Safety Evaluation at RP2D
Incidence of Grade 3 and higher treatment-related AEs
Measured: 24 Months
Secondary outcomes (3)
Evaluation of the anti-tumor response of R3/RT/PD-1
Evaluation of the Objective Response Rate: complete or partial response, as defined by RECIST 1.1 and iRECIST
Measured: 24 months
Assessment of the safety and feasibility of R3/RT/PD-1
Assessment of the number of participants with related late onset toxicities defined as any Grade ≥3 AE occurring after the EOT visit and determination of the number of participants with feasible NBTXR3 intratumoral injection
Measured: 24 months
Evaluation of the body kinetic profile of intratumorally injected NBTXR3
Evaluation of the time-course dependent accumulation of hafnium in blood and urine following NBTXR3 intratumoral injection
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start16 Jan 2019
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RadiotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanobiotix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pavel Tyan, MD, Study director, Nanobiotix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589339
- Sponsor's protocol ID
- 1100
- Status last verified
- Oct 2025
- First submitted
- 10 Apr 2018
- Last updated
- 24 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03589339
- Acronym / sponsor ID
- 1100
- Conditions
- Radiotherapy, Immunotherapy, Microsatellite Instability-High Solid Malignant Tumour, Metastasis From Malignant Tumor of Liver, Squamous Cell Carcinoma of Head and Neck, Metastasis From Malignant Tumor of Cervix
- Keywords
- Oral Cavity Cancer, Oropharynx Cancer, Lung Metastasis, Liver Metastasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- NanobiotixIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 17 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 in dose escalation and expansion parts. The Escalation Cohort 1 includes patients with LRR or R/M HNSCC with the injectable lesion in a previously irradiated field. In Escalation Cohorts 2 and 3, patients present with lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy.
The Expansion cohort 1 includes patients with LRR or R/M HNSCC with the injectable lesion located either in head and neck area or in lung or liver, who are resistant to anti-PD-1 therapy. The Expansion cohort 2 includes patients with LRR or R/M HNSCC with the injectable lesion located either in head and neck area or in lung or liver, who are naive to anti-PD-1 therapy.
The Expansion Cohort 3 includes patients with inoperable NSCLC, malignant melanoma, HCC, RCC, urothelial cancer, cervical cancer or TNBC with metastases to lungs, liver or soft tissue and who are resistant to 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 for 2 years after the EOT visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NBTXR3 activated by SABR followed by anti-PD-1 monotherapy | Experimental | Drug: NBTXR3, Radiation: SABR, Drug: Nivolumab, Drug: PembrolizumabIntratumoral injection of NBTXR3 followed by SABR followed by monotherapy with nivolumab or pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Signed informed consent form
- Biopsy-confirmed cancer diagnosis indicated to receive anti-PD-1 therapy:
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NBTXR3Single intra Tumoral injection | Drug | NBTXR3 activated by SABR followed by anti-PD-1 monotherapy |
| SABRAlso: Stereotaxic Ablative Radiotherapy, Stereotaxic Body Radiation TherapyRadiotherapy given as a definite number of fractions at the dose defined for each radiation field | Radiation | NBTXR3 activated by SABR followed by anti-PD-1 monotherapy |
| NivolumabAlso: OpdivoAnti-PD-1 monotherapy | Drug | NBTXR3 activated by SABR followed by anti-PD-1 monotherapy |
| PembrolizumabAlso: KeytrudaAnti-PD-1 monotherapy | Drug | NBTXR3 activated by SABR followed by anti-PD-1 monotherapy |
Primary outcome
[Dose Escalation Part]: Determination of the Recommended Dose
Time frame: 24 Months
Determination of DLTs, the MTD (if possible), and RP2Ds for each cohort
[Dose Expansion Part]: Safety Evaluation at RP2D
Time frame: 24 Months
Incidence of Grade 3 and higher treatment-related AEs
3 secondary outcomes
Evaluation of the anti-tumor response of R3/RT/PD-1
Time frame: 24 months
Assessment of the safety and feasibility of R3/RT/PD-1
Time frame: 24 months
Evaluation of the body kinetic profile of intratumorally injected NBTXR3
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
- BackgroundShen 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pavel Tyan, MD study director
Nanobiotix
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NBTXR3, SABR and Nivolumab in people with Radiotherapy and Immunotherapy, run by Nanobiotix at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[Dose Escalation Part]: Determination of the Recommended Dose (time frame: 24 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03589339, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2025.