Evaluation of GLR2007 for Advanced Solid Tumors

Inclusion Criteria

• •1. For Part 1 (Dose Escalation): Participants with advanced solid tumors who are refractory or intolerant to therapies known to provide clinical benefit.
• •1. 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.
• •2. For Part 2 (Dose Expansion): The participant must have histological or cytological evidence of cancer that is advanced and/or metastatic.
• •2. For Part 1 (Dose Escalation): The participant has measurable or non-measurable disease.
• •3. For Part 2 (Dose Expansion): The participant has measurable disease.
• •4. The participant has given written informed consent prior to all study-specific procedures.
• •5. The participant has adequate hematologic, hepatic, and renal function.
• •6. 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.
• •7. 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.
• •8. The participant meets contraceptive requirements.
• •9. The participant has an estimated life expectancy of ≥3 months.
• •10. The participant agrees to minimize ultraviolet exposure and sunlight for the duration of their study participation.
• •11. 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.
• •1. Histologically or cytologically confirmed NSCLC.
• •2. 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.
• •3. 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.
• •Part 2 (Cohort B, Brain metastases of breast or NSCLC origin)
• •1. Histologically or cytologically confirmed NSCLC or breast cancer at primary site.
• •2. Participants with inoperable brain metastases (prior radiation therapy and/or stereotactic radiosurgery is allowed). A neurosurgical consult is at the discretion of the investigator.
• •3. 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.
• •4. 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.
• •5. Participants with brain metastases from breast cancer who have previously received CDK4/6 inhibitors.
• •Part 2 (Cohort C, GBM)
• •2. First recurrence of GBM.
• •3. Candidate for surgical partial or gross-total resection.
• •4. Radiographic demonstration of disease progression by contrast-enhanced CT or MRI following prior therapy.
• •5. At least 2 weeks between prior surgical resection and adequate wound healing.
• •6. 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.