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

Part of paid clinical trials in San Francisco, California.

Sponsor
Nanobiotix
Study ID
NCT03589339
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Immunotherapy
  • Metastasis From Malignant Melanoma of Skin (Disorder)
  • Metastasis From Malignant Tumor of Bladder (Disorder)
  • Metastasis From Malignant Tumor of Cervix
  • Metastasis From Malignant Tumor of Liver
  • Metastatic NSCLC
  • Metastatic Renal Cell Carcinoma
  • Metastatic Triple-Negative Breast Carcinoma
  • Microsatellite Instability-High Solid Malignant Tumour
  • Radiotherapy
  • Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NBTXR3 — DRUG
    Single intra Tumoral injection
  • SABR — RADIATION
    Radiotherapy given as a definite number of fractions at the dose defined for each radiation field
  • Nivolumab — DRUG
    Anti-PD-1 monotherapy
  • Pembrolizumab — DRUG
    Anti-PD-1 monotherapy

Study Details

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.

Key Dates

Start date
Jan 16, 2019
Status verified
Oct 2025
Primary completion
Apr 30, 2027
Completion
Aug 30, 2027

Study Design

Enrollment
145 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: NBTXR3 activated by SABR followed by anti-PD-1 monotherapy
    Intratumoral injection of NBTXR3 followed by SABR followed by monotherapy with nivolumab or pembrolizumab

Primary Outcome Measure

[Dose Escalation Part]: Determination of the Recommended Dose [ Time Frame: 24 Months ]

Locations (13)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94158-
Moffitt Cancer CenterTampaFlorida33612-
Emory UniversityAtlantaGeorgia30308-
University of Chicago Medical CenterChicagoIllinois60637-
Johns Hopkins University, Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21287-
Henry Ford Cancer InstituteDetroitMichigan48202-
Karmanos Cancer InstituteDetroitMichigan48201-
Christus St. Vincent Regional Cancer CenterSanta FeNew Mexico87505-
Northwell HealthManhassetNew York11030-
University of North Carolina, School of MedicineChapel HillNorth Carolina27516-
Gabrail Cancer CenterCantonOhio44718-
St Luke's University Health NetworkBethlehemPennsylvania18015-
Sanford Cancer CenterSioux FallsSouth Dakota57104-

Find similar trials in San Francisco, CA

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
University of California San Francisco· San Francisco, CAMoffitt Cancer Center· Tampa, FLEmory University· Atlanta, GAUniversity of Chicago Medical Center· Chicago, ILJohns Hopkins University, Sidney Kimmel Comprehensive Cancer Center· Baltimore, MDHenry Ford Cancer Institute· Detroit, MI

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