Status:
TERMINATED
(Concerto) Study of BLU-451 in Advanced Cancers With EGFR Exon 20 Insertion Mutations
Lead Sponsor:
Blueprint Medicines Corporation
Conditions:
Lung Neoplasm Malignant
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase 1/2, open-label first-in-human study of the safety, pharmacokinetics (PK), pharmacodynamics, and anti-tumor activity of BLU-451 monotherapy and BLU-451 in combination with platinum-bas...
Detailed Description
The study is a Phase 1/2 Study of BLU-451 in Advanced Cancers with Epidermal growth factor receptor (EGFR) Exon 20 Insertion Mutations (Ex20ins). The study has two phases: An initial Phase 1 portion ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- All participants:
- Documented EGFR mutation, based on Next-generation sequencing (NGS) testing of tumor or liquid biopsy analyzed in a local Clinical Laboratory Improvement Amendments (CLIA) (or International Organization for Standardization (ISO) 15189)-certified or equivalent laboratory are required. Redacted copies of laboratory results must be available for Sponsor review.
- Able to provide a new or archived pretreatment formalin-fixed, paraffin-embedded (FFPE) tumor sample. For participants who received EGFR-targeted therapy subsequent to the most recent archived biopsy, all efforts should be made to obtain a new biopsy unless it is not safe or feasible to obtain one.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Participants must be without seizures for at least 14 days prior to enrollment, and patients who receive treatment with anti-epileptic drugs must be on stable doses for at least 14 days prior to enrollment.
- Adequate hematological, renal, and hepatic function:
- Participants in Phase 1
- Histologically or cytologically confirmed metastatic NSCLC (stage IVA and IVB per American Joint Committee on Cancer (AJCC) 8th edition) or other metastatic cancers except for primary CNS tumors (Part 1A or Part 2 only).
- Must have evaluable or measurable disease per RECIST v1.1.
- Progression on or after or intolerance to most recent systemic therapy.
- Participants in Phase 2
- Histologically or cytologically confirmed metastatic NSCLC (stage IVA and IVB per AJCC 8th edition).
- Must have measurable disease by RECIST 1.1.
- EXCLUSION CRITERIA:
- Have disease that is suitable for local therapy administered with curative intent.
- Have tumor that harbors known driver alterations (including, but not limited to ROS, BRAF V600E, ALK, RET, HER2, MET, KRAS, NTRK1/2/3, EGFR C797X, or EGFR T790M mutation). These criteria are not applicable to Phase 1 Part 1B.
- Have NSCLC with mixed cell histology or a tumor with known histologic transformation (NSCLC to SCLC, SCLC to NSCLC, or epithelial to mesenchymal transition).
- Other protocol-defined inclusion and exclusion criteria apply
Exclusion
Key Trial Info
Start Date :
March 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT05241873
Start Date
March 4 2022
End Date
July 31 2024
Last Update
February 10 2025
Active Locations (23)
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1
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States, 91010
2
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States, 90048
3
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, United States, 80045
4
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007