BridgeMD
Phase 1/2 Study of BLU-451 in certain advanced cancers
EU CTIS ID: 2022-502527-21-00
What this study is testing
Main Objective 1 Phase 1: To determine the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of BLU-451 monotherapy and in combination with platinum based chemotherapy Main Objective 2 Phase 1: To characterize the safety and tolerability of BLU-451 monotherapy and in combination with platinum based chemotherapy Main Objective 1 Phase 2: To evaluate the anti-tumor activity of BLU-451 monotherapy at the RP2D using RECIST v1.1
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. (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.
- 10. (Only Phase 2). Must have measurable disease by RECIST 1.1.
- 2. (All participants). 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.
- 3. (All participants). Estado funcional según el Eastern Cooperative Oncology Group (ECOG) de 0 o 1.
- 4. (All participants). 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.
- 5. (All participants). Adequate hematological, renal, and hepatic function.
You likely can't join if
- 1. Have disease that is suitable for local therapy administered with curative intent.
- 2. 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.
- 3. Have NSCLC with mixed cell histology or a tumor with known histologic transformation (NSCLC to SCLC, SCLC to NSCLC, or epithelial to mesenchymal transition).
See the full eligibility criteria
- 1. (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.
- 10. (Only Phase 2). Must have measurable disease by RECIST 1.1.
- 2. (All participants). 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.
- 3. (All participants). Estado funcional según el Eastern Cooperative Oncology Group (ECOG) de 0 o 1.
- 4. (All participants). 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.
- 5. (All participants). Adequate hematological, renal, and hepatic function.
- 6. (Only 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).
- 7. (Only Phase 1). Must have evaluable or measurable disease per RECIST v1.1.
- 8. (Only Phase 1). Progression on or after or intolerance to most recent systemic therapy.
- 9. (Only Phase 2). Histologically or cytologically confirmed metastatic NSCLC (stage IVA and IVB per AJCC 8th edition).
- 1. Have disease that is suitable for local therapy administered with curative intent.
- 2. 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.
- 3. Have NSCLC with mixed cell histology or a tumor with known histologic transformation (NSCLC to SCLC, SCLC to NSCLC, or epithelial to mesenchymal transition).
The study team makes the final eligibility decision.
Where it's taking place
- Singapore
- United States
- Taiwan
- Canada
- United Kingdom
- Korea, Democratic People's Republic of
- Hong Kong
- Japan
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore; United States; Taiwan; Canada; United Kingdom; Korea, Democratic People's Republic of and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.