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For Part 1 (Dose Escalation): Participants with advanced solid tumors who are refractory or intolerant to therapies known to provide clinical benefit |
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For Part 1 (Dose Escalation): The participant must have histological or cytological evidence of cancer (a solid tumor) that is advanced and/or metastatic. Biopsy is allowed by protocol if no histology or cytology records are available |
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For Part 2 (Dose Expansion): The participant must have histological or cytological evidence of cancer that is advanced and/or metastatic |
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For Part 1 (Dose Escalation): The participant has measurable or non-measurable disease |
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For Part 2 (Dose Expansion): The participant has measurable disease |
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The participant has given written informed consent prior to all study-specific procedures |
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The participant has adequate hematologic, hepatic, and renal function |
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The participant has discontinued all prior cancer therapies (including chemotherapy, immunotherapy, and investigational therapy) for at least 21 days for myelosuppressive agents or 14 days for radiotherapy and non-myelosuppressive agents, prior to receiving GLR2007, and has recovered from the acute effects of therapy (treatment related toxicity resolved to Grade 1) except for residual alopecia |
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The participant is willing and able to make themselves available for the duration of the study and is willing and able to follow study procedures |
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The participant meets contraceptive requirements |
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The participant has an estimated life expectancy of 3 months |
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The participant agrees to minimize ultraviolet exposure and sunlight for the duration of their study participation |
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A diagnostic contrast-enhanced magnetic resonance imaging (MRI) of the brain must be performed within 28 days prior to registration. Contrast-enhanced computed tomography (CT) is acceptable if MRI is not possible |
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Cohort-specific inclusion criteria Part 2 (Cohort A, NSCLC) |
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Histologically or cytologically confirmed NSCLC |
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Participants must have received at least 1 line of standard therapy for metastatic disease, including platinum-based chemotherapy and an immune checkpoint inhibitor given together or as separate lines of therapy, unless participants are ineligible for or cannot tolerate such therapy |
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Participants with anaplastic lymphoma kinase (ALK), epidermal growth factor receptor (EGFR), proto-oncogene tyrosine-protein kinase ROS (ROS1), v-Raf murine sarcoma viral oncogene homolog B (BRAF), and neurotrophic receptor tyrosine kinase 1 (NTRK) aberrations must have received therapy directed at their molecular aberration in order to enroll on this study |
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Part 2 (Cohort B, Brain metastases of breast or NSCLC origin) |
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Histologically or cytologically confirmed NSCLC or breast cancer at primary site |
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Participants with inoperable brain metastases (prior radiation therapy and/or stereotactic radiosurgery is allowed). A neurosurgical consult is at the discretion of the investigator |
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Participants with brain metastases of NSCLC origin must have received at least 1 line of standard therapy for metastatic disease, including platinum-based chemotherapy and an immune checkpoint inhibitor given together or as separate lines of therapy, unless participants are ineligible for or cannot tolerate such therapy |
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Participants with ALK, EGFR, ROS1, BRAF, and NTRK aberrations must have received therapy directed at their molecular aberration in order to enroll on this study |
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Participants with brain metastases from breast cancer who have previously received CDK4/6 inhibitors |
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Part 2 (Cohort C, GBM) |
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Histologically confirmed diagnosis of a recurrent primary World Health Organization Grade IV malignant glioblastoma. Participants with recurrent disease whose diagnostic pathology confirmed glioblastoma will not need re-biopsy. Participants with prior low-grade glioma or anaplastic glioma are eligible if histologic assessment demonstrates transformation to GBM |
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First recurrence of GBM |
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Candidate for surgical partial or gross-total resection |
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Radiographic demonstration of disease progression by contrast-enhanced CT or MRI following prior therapy |
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At least 2 weeks between prior surgical resection and adequate wound healing |
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At least 12 weeks from prior radiotherapy unless there is either histopathologic confirmation of recurrent tumor or new enhancement on MRI outside of the treatment field |
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The participant has a personal history of any of the following conditions: major surgical resection involving the stomach or small bowel recurrent, unexplained or cardiac-related syncopal episodes within the last 6 months or ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation)
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Any concurrent malignancies currently requiring treatment or for which treatment would be deemed necessary within 3 months of enrollment; prostate cancer with androgen deprivation therapy, basal cell cancer, and squamous cell cancers are allowed
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The participant is pregnant or lactating
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The participant is immunocompromised and known to be human immunodeficiency virus positive. The participant has an active bacterial, fungal, and/or known viral infection (for example, hepatitis B surface antigen or hepatitis C antibodies)
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Cohort-specific exclusion criteria
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Part 2 (Cohort A, NSCLC): The participant has NSCLC with worsening symptoms
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within 14 days prior to receiving GLR2007
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Part 2 (Cohort B, Brain metastases of breast or NSCLC origin): The participant
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has CNS metastasis with worsening symptoms within 14 days prior to receiving
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GLR2007
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Part 2 (Cohort C, GBM): The participant has GBM with worsening symptoms within
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days prior to receiving GLR2007
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