Physician

Neil Belman, DO

Study Coordinator

Angela Rankin
484-658-1792
Angela.Rankin@sluhn.org

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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

Nicholas Taylor, MD

Study Coordinator

Janine Schippang
484-658-1790

JanineL.Schippang@sluhn.org

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The purpose of this research study is to determine if the combination of relacorilant and nab-paclitaxel controls cancer better than nab-paclitaxel alone in women with ovarian, primary peritoneal, or fallopian tube cancer that has progressed or spread to other areas of the body after prior anti-cancer therapies.

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• Histologic diagnosis of high-grade (grade 3) serous, epithelial ovarian, primary peritoneal, or fallopina tube cancer (high-grade endometrioid or carcinosarcoma with ≥ 30% endometrioid epithelial tumor component are eligible)
• Platinum-resistant disease, defined as RECIST v1.1 progression < 6 months from completion of a platinum-containing therapy
• Must consent to provide archival tumor-tissue block or slides
• Must have at least one lesion that is measurable by RECIST v1.1
• Patients must have received at least 1 but ≤ 3 prior systemic lines of therapy
• At least one prior line of platinum therapy is required and treatment with bevacizumab is required
• Patients must be able to swallow and retain oral medication (i.e. does no thave uncontrolled emesis)
• No prior chemotherapy, immunotherapy or investigational agent within 28 days before first dose of study drug
• No radiotherapy within 2 weeks of first dose of study drug
• No hormonal anticancer therapy within 7 days of first dose of study drug
• No systemic, inhaled or prescription strength topical corticosteroids within 21 days of first dose of study drug
• ECOG PS 0 or 1
• Life expectancy of ≥ 3 months

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Physician

Ashley Graul MD

Study Coordinator

Janine Schippang
484-658-1790

JanineL.Schippang@sluhn.org

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Synopsis: Blood and Tissue Procurement Protocol for Product Development and Research

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• Patients must agree to collection of blood and/or tumor tissue/fluid that is obtained during a standard of care procedure or visit (as of 5/11/23 - no blood collection is necessary unless specifically requested by sponsor)
• For Ovarian cancer - fresh tissue collection of frontline, newly diagnosed, treatment naive, Stage IIIb or IV or first recurrenct, platinum-sensitive tumors (tissue collection must occur prior to initiation of any systemic therapy for recurrence)
• For Ovarian cancer - fluid collection from first tap of ascited or pleural fluid of first recurrence, platinum-sensitive tumors (can be collected prior to or after systemic therapy for recurrence is initiated)

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