Phase 1/2 Study of BLU-451 in Advanced Cancers with EGFR Exon 20 Insertion Mutations

JRCT ID: jRCT2031220390

Registered date:18/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Advanced cancer with EGFR Exon 20ins Mutations
• Date of first enrollment: 05/01/2023
• Target sample size: 15
• Countries of recruitment: US,Japan,Taiwan,Japan,South Korea,Japan,Canada,Japan
• Study type: Interventional

Intervention(s)

Determined dose of BLU-451 is orally administered BID or
QD for each phase/cohort.

Outcome(s)

Primary Outcome

Phase 1:
Determine the maximum tolerated dose (MTD) of BLU-451
Determine the Recommended Phase 2 Dose (RP2D) of BLU-451
Rate and severity of Adverse Events (AEs) of BLU-451
Phase 2:
The Overall Response Rate (ORR) rate of BLU-451

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Other protocol-defined inclusion criteria apply

Exclude 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).
- 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 exclusion criteria apply

Related Information

• Primary Sponsor: Zalutskaya Alena
• Secondary ID(s): NCT05241873