ACTIVE_NOT_RECRUITING

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

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 Metastatic Renal Cell Carcinoma Metastasis From Malignant Melanoma of Skin (Disorder)Metastatic Triple-Negative Breast Carcinoma Metastatic NSCLC Metastasis From Malignant Tumor of Bladder (Disorder)Oral Cavity Cancer Oropharynx Cancer Lung Metastasis Liver Metastasis

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2019-01-16

Study Completion:2027-08-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03589339

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Signed informed consent form * Biopsy-confirmed cancer diagnosis indicated to receive anti-PD-1 therapy: 1. 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 2. Escalation Cohort 2: Has metastasized to the lung (including involved lymph nodes) with tumor in a previously non-irradiated lung field, or 3. Escalation Cohort 3: Has metastasized to the liver with tumor in a previously non-irradiated liver field 1. 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 2. 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: 1. Has not received prior anti-PD-1 therapy (i.e., anti-PD-1 naïve), or 2. 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 3. 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) 1. 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 2. 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	* 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 * Any condition for which participation would not be in the best interest of the participant

Inclusion Criteria

Exclusion Criteria

* Signed informed consent form
* Biopsy-confirmed cancer diagnosis indicated to receive anti-PD-1 therapy:
1. 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
2. Escalation Cohort 2: Has metastasized to the lung (including involved lymph nodes) with tumor in a previously non-irradiated lung field, or
3. Escalation Cohort 3: Has metastasized to the liver with tumor in a previously non-irradiated liver field
1. 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
2. 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:
1. Has not received prior anti-PD-1 therapy (i.e., anti-PD-1 naïve), or
2. 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
3. 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)
1. 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
2. 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

* 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
* Any condition for which participation would not be in the best interest of the participant

Contacts and Locations

Principal Investigator

Pavel Tyan, MD

STUDY_DIRECTOR

Nanobiotix

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Nanobiotix

Pavel Tyan, MD, STUDY_DIRECTOR, Nanobiotix

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-01-16

Study Completion Date2027-08-30

Study Record Updates

Study Start Date2019-01-16

Study Completion Date2027-08-30

Terms related to this study

Keywords Provided by Researchers

Oral Cavity Cancer
Oropharynx Cancer
Lung Metastasis
Liver Metastasis

Additional Relevant MeSH Terms

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
Metastatic Renal Cell Carcinoma
Metastasis From Malignant Melanoma of Skin (Disorder)
Metastatic Triple-Negative Breast Carcinoma
Metastatic NSCLC
Metastasis From Malignant Tumor of Bladder (Disorder)