Clinical trial · Interventional
(Concerto) Study of BLU-451 in Advanced Cancers With EGFR Exon 20 Insertion Mutations
Phase I/II Study of BLU-451 in Advanced Cancers With EGFR Exon 20 Insertion Mutations
NCT05241873CI-TRIAL-00085713terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decision, not related to safety concerns
Summary
Brief summary (as posted)
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-based chemotherapy (carboplatin and pemetrexed). All participants will receive BLU-451 on a 21-day treatment cycle.
Conditions
Conditions (20)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Antineoplastic Agents | — | UNRESOLVED | — |
| Brain Metastases | — | UNRESOLVED | — |
| Bronchial Neoplasms | — | UNRESOLVED | — |
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Carcinoma, Bronchogenic | Bronchogenic Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| EGFR Activating Mutation | — | UNRESOLVED | — |
| EGFR Atypical Mutations, Including G719X and L861Q | — | UNRESOLVED | — |
| EGFR Exon 20 Insertion Mutation | — | UNRESOLVED |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BLU-451 | Drug | — | UNRESOLVED |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (10)
- type
- EXPERIMENTAL
- label
- Phase I - Part 1A Dose Escalation
- description
- BLU-451 monotherapy with dose escalation in participants with metastatic cancer with EGFR Ex20ins or other selected EGFR mutations that have progressed after prior systemic therapies.
- interventionNames
- Drug: BLU-451
- type
- EXPERIMENTAL
- label
- Phase I - Part 1B Dose Escalation (US only)
- description
- BLU-451 with dose escalation in combination with carboplatin and pemetrexed in participants with metastatic NSCLC with common EGFR mutations. This arm will enroll participants only in the United States.
- interventionNames
- Drug: BLU-451
- Drug: Carboplatin
- Drug: Pemetrexed
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.