Breast Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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:

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

Exclusion Criteria:

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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

145

Study ID:

NCT03589339

Recruitment Status:

Recruiting

Sponsor:

Nanobiotix

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There are 8 Locations for this study

See Locations Near You

Christiana Care Health Services
Newark Delaware, 19713, United States More Info
Jamal Misleh, MD
Contact
Moffitt Cancer Center
Tampa Florida, 33612, United States More Info
Jessica Frakes, MD
Contact
University of Chicago Medical Center
Chicago Illinois, 60637, United States More Info
Ari Rosenberg, MD
Contact
Johns Hopkins University, Sidney Kimmel Comprehensive Cancer Center
Baltimore Maryland, 21287, United States More Info
Tanguy Seiwert, MD
Contact
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Theodore Hong, MD
Contact
Quantum Santa Fe
Santa Fe New Mexico, 87505, United States More Info
Scott Herbert, MD
Contact
University of North Carolina, School of Medicine
Chapel Hill North Carolina, 27516, United States More Info
Colette Shen, MD, PhD
Contact
Gabrail Cancer Center
Canton Ohio, 44718, United States More Info
Nashat Gabrail, MD
Contact

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

145

Study ID:

NCT03589339

Recruitment Status:

Recruiting

Sponsor:


Nanobiotix

How clear is this clinincal trial information?

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