Physician

Neil Belman, DO

Study Coordinator

Cynthia Evancho
484-658-2534
Cynthia.Evancho@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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Synopsis: A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer With FGFR2b Overexpression (NCT 05111626)

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• Histologically documented gastric or GEJ adenocarcinoma that is unresectable, locally advanced or metastatic (not amenable to curative therapy)
• ECOG PS 0 or 1
• Measurable disease or non-measurable, but evaluable disease, according to RECIST v1.1
• No known contraindications to mFOLFOX6 chemotherapy or nivolumab
• No prior treatment for metastatic or unresectable disease except for a maximum of 1 dose of mFOLFOX6 with or without nivolumab; prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed provided it was completed more than 6 months prior to first dose of study treatment
• For Part 2: FGFR2b overexpression positive as determined by central IHC testing
• Patients may not have untreated or symptomatic CNS metastases or leptomeningeal disease
• Patients with tumors with known positive HER2 status are excluded
• No evidence of any ongoing ophthalmologic abnormalities or symptoms that are acute or actively progressing; must be willing to avoid use of contact lenses while on study treatment
• Patients with sensory neuropathy grade 2 or higher are excluded

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