Physician

Neil Belman, DO

Study Coordinator

Angela Rankin
email: Angela.Rankin@sluhn.org
phone: 484-658-1792

 

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This is a Phase 2 study evaluating the efficacy of a CDK, PI3K, or NTRK/ROS1 inhibitor in patients with progressive brain metastases from solid tumors harboring the alterations predicting sensitivity to each of these inhibitors.

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• Histologically confirmed parenchymal metastatic disease to the brain from any solid tumor

• Tissue must be available for biomarker testing (any brain metastasis tissue and extracranial site from any prior resection or biopsy). If extracranial tissue is not available or there is no evidence of extracrania disease, brain metastasis tissue is sufficient for eligibility

• Measurable CNS disease (≥ 10mm) that is new or progressive after systemic therapy or prior radiotherapy

• Patients must be able to undergo MRI with contrast

• Presence of clinically actionable alteration in NTRK, ROS1, CDK pathway or PI3K pathway in both a brain metastais and extracranial site per central review

• For HER2+ breast cancer, patients must have received prior HER-2 directed therapy in the metastatic setting

• For TNBC, patients must have had at least one chemotherpy in the metastatic setting

• For ER and/or PR+ HER2- breast cancer, patients must have had at least one endocrine therapy in the metastatic setting

• For melanoma, patietnts must have progressed after immunotherapy or after BRAF/MEK inhibitors for BRAF+ disease

• For lung cancer, patients must have failed EGFR therapies for EGFR mutated disease

• No known current diffuse leptomeningeal involvement

• No surgery within 2 weeks prior to or after registration

• No chemotherapy within 14 days prior to registration

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Physician

William Smith, MD

Study Coordinator

Angela Rankin
email: Angela.Rankin@sluhn.org
phone: 484-658-1792

 

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The purpose of this research is to determine the recommended dose(s), safety, efficacy and tolerability of the study drug NBTXR3. NBTXR3 is a sterile white suspension made of hafnium oxide nanoparticles that will be injected directly into the tumor. NBTXR3 is an experimental drug made of extremely small particles with a special coating designed to get inside and stay inside cancer cells. These particles are designed to improve the benefit of Radiation Therapy to treat your cancer. It will be directly injected into a tumor that will then be radiated. After completion of radiation, patients will undergo treatment with immunotherapy with an anti-PD-1 inhibitor at the direction of their medical oncologist.

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Your study doctor will determine whether this clinical trial is an appropriate option for you. Some key eligibility criteria are as follows:

• Patients must have biopsy-confirmed advanced/unresectable malignant solid tumor diagnosis indicated to receive an FDA-approved anti-PD-1 therapy that:
  • Is inoperable locoregional recurrent or metastatic HNSCC with at least one lesion that is amenable to irradiation within head and neck region, lung or liver
  • Is inoperable cancer of the lung, liver, kidney, bladder, cervix, breast (triple negative) or malignant melanoma that has metastasized to soft tissues, lung (including mediastinal lymph nodes) or liver with at least one lesion that is amenable to irradiation
• Patients must have received prior anti-PD-1 therapy and meet criteria consistent with anti-PD-1 primary or secondary resistance or have not received anti-PD-1 therapy (i.e., anti-PD1 naïve)
• Patients must have at least one tumor lesion that can be accurately measured according and is amenable for intratumoral injection and amenable for irradiation, as determined by the study investigator
• Patients cannot have a history of immune-related adverse events related to the 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 is not allowed
• Active autoimmune disease that has required systemic treatment in 1 year before study treatment (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) is not allowed
• Extensive metastatic disease burden defined as more than five lesions overall including the primary tumor is not allowed
• Patients must not have received prior systemic anti-neoplastic therapy, including investigational agents, within 4 weeks prior to NBTXR3 injection
• Patient must not have received prior therapy with a checkpoint inhibitor (e.g., anti-CTLA-4, anti-PD-1/L1, and/or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) within two weeks prior to NBTXR3 injection

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