Status:
COMPLETED
Evaluation of GLR2007 for Advanced Solid Tumors
Lead Sponsor:
Gan and Lee Pharmaceuticals, USA
Conditions:
Non-small Cell Lung Cancer
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Evaluation of GLR2007 for Advanced Solid Tumors
Detailed Description
An Open-Label, Multicenter, Phase 1b/2 Study to Establish Safety, Tolerability, and Optimal Dosing Strategy of GLR2007 in Subjects with Advanced Solid Tumors
Eligibility Criteria
Inclusion
- For Part 1 (Dose Escalation): Participants with advanced solid tumors who are refractory or intolerant to therapies known to provide clinical benefit.
- 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.
- For Part 2 (Dose Expansion): The participant must have histological or cytological evidence of cancer that is advanced and/or metastatic.
- For Part 1 (Dose Escalation): The participant has measurable or non-measurable disease.
- For Part 2 (Dose Expansion): The participant has measurable disease.
- The participant has given written informed consent prior to all study-specific procedures.
- The participant has adequate hematologic, hepatic, and renal function.
- 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.
- 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.
- The participant meets contraceptive requirements.
- The participant has an estimated life expectancy of ≥3 months.
- The participant agrees to minimize ultraviolet exposure and sunlight for the duration of their study participation.
- 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.
- Cohort-specific inclusion criteria Part 2 (Cohort A, NSCLC)
- Histologically or cytologically confirmed NSCLC.
- 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.
- 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)
- Histologically or cytologically confirmed NSCLC or breast cancer at primary site.
- Participants with inoperable brain metastases (prior radiation therapy and/or stereotactic radiosurgery is allowed). A neurosurgical consult is at the discretion of the investigator.
- 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.
- 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.
- Participants with brain metastases from breast cancer who have previously received CDK4/6 inhibitors.
- Part 2 (Cohort C, GBM)
- 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.
- First recurrence of GBM.
- Candidate for surgical partial or gross-total resection.
- Radiographic demonstration of disease progression by contrast-enhanced CT or MRI following prior therapy.
- At least 2 weeks between prior surgical resection and adequate wound healing.
- 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.
Exclusion
- 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).
- 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.
- The participant is pregnant or lactating.
- 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).
- Cohort-specific exclusion criteria:
- Part 2 (Cohort A, NSCLC): The participant has NSCLC with worsening symptoms within 14 days prior to receiving GLR2007.
- Part 2 (Cohort B, Brain metastases of breast or NSCLC origin): The participant has CNS metastasis with worsening symptoms within 14 days prior to receiving GLR2007.
- Part 2 (Cohort C, GBM): The participant has GBM with worsening symptoms within 14 days prior to receiving GLR2007.
Key Trial Info
Start Date :
July 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2022
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04444427
Start Date
July 15 2020
End Date
July 29 2022
Last Update
December 23 2022
Active Locations (4)
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1
USA002
Lafayette, Indiana, United States, 47905
2
USA005
Omaha, Nebraska, United States, 68130
3
USA001
Philadelphia, Pennsylvania, United States, 19111
4
USA004
Dallas, Texas, United States, 75230