NBTXR3 Activated by Radiotherapy for Patients with Advanced Cancers Treated with an Anti-PD-1 Therapy

Launched by NANOBIOTIX · Jul 4, 2018

Keywords

ClinConnect Summary

The clinical trial titled "NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy" is exploring a new treatment approach for patients with advanced cancers. Specifically, it is looking at the safety of a special treatment called NBTXR3, which is injected directly into tumors and activated by radiation, when combined with an existing immunotherapy called anti-PD-1 therapy. This study is open to adults aged 65 and older who have been diagnosed with specific types of cancers that require anti-PD-1 therapy and have certain tumors that can be treated with radiation.

To participate, individuals need to provide signed consent and have a confirmed cancer diagnosis. They may have received prior anti-PD-1 treatment or be new to it. Participants will have their tumors monitored and can expect to receive the NBTXR3 injection along with radiotherapy. This trial is currently recruiting, and it aims to find out how safe this new treatment combination is for patients. If you or someone you know might be interested, it’s important to discuss this with a healthcare provider to understand if this trial is a good fit.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Signed informed consent form
• * Biopsy-confirmed cancer diagnosis indicated to receive anti-PD-1 therapy:
• Dose Escalation:
• • 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
• Expansion:
• • 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:
• Dose Escalation (all cohorts):
• • 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)
• Expansion:
• • 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
• 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