Clinical trial for Non-small Cell Lung Cancer
Official title Phase 1/2 Trial of S241656 in Selected RAS/MAPK Mutation- Positive Malignancies
ClinicalTrials.gov ID: NCT05786924
What this study is testing
What is S241656?
This is an investigational oral medicine being studied as a potential treatment for non-small cell lung cancer. It is designed to block specific proteins called RAF that help cancer cells grow.
Also referred to as BDTX-4933.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing how safe a new medicine is. It also looks at how well it works for certain cancers.
- Who it's for
- You may be able to join if you have advanced cancer with specific gene changes.
- What's involved
- You would take a pill by mouth. You would take it in 28-day cycles until the study ends.
- Time commitment
- You would take the pill until your cancer grows or you stop taking part.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Life expectancy of ≥ 12 weeks in the opinion of the investigator.
- Histologically or cytologically confirmed recurrent locally advanced (unresectable) or metastatic solid tumors with documented RAS or RAF mutations...
- Adequate bone marrow and organ function.
- Part 1A: Advanced/metastatic NSCLC with KRAS non-G12C, HRAS, NRAS, BRAF or CRAF (RAF1) mutations or alterations
- Part 1B: Advanced/metastatic GI tumors (e.g., PDAC, CRC, and BTC) with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations
You likely can't join if
- Cancer that has a known MEK1/2 mutation.
- Known allergy/hypersensitivity to excipients of S241656 or to any of the registered IMPs administered in combination.
- Any contra-indication, to use of any of the combination chemotherapy or anti-EGFR therapy partners administered as part of this trial.
- Major surgery within 4 weeks of study entry or planned during study.
- Ongoing anticancer therapy.
- Ongoing radiation therapy.
See the full eligibility criteria
- Life expectancy of ≥ 12 weeks in the opinion of the investigator.
- Histologically or cytologically confirmed recurrent locally advanced (unresectable) or metastatic solid tumors with documented RAS or RAF mutations or alterations.
- Adequate bone marrow and organ function.
- Part 1A: Advanced/metastatic NSCLC with KRAS non-G12C, HRAS, NRAS, BRAF or CRAF (RAF1) mutations or alterations
- Part 1B: Advanced/metastatic GI tumors (e.g., PDAC, CRC, and BTC) with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations
- Part 1C: Advanced/metastatic PDAC with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations
- Part 1D: Colorectal adenocarcinoma with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations
- Part 2A: Advanced/metastatic NSCLC with KRAS non-G12C mutations and/or BRAF mutations
- Part 2A1: Advanced/metastatic NSCLC with KRAS non-G12C mutations
- Part 2A2: Advanced/metastatic NSCLC with BRAF mutations
- Part 2A3: Advanced/metastatic NSCLC with KRAS non-G12C or BRAF mutations or alterations and active CNS metastatic disease
- Part 2A4: Advanced/metastatic NSCLC with a KRAS G12C mutation
- Part 2B1: Advanced/metastatic PDAC with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations
- Part 2B2: Advanced/metastatic CRC with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations
- Part 2B3: Advanced/metastatic BTC (adenocarcinoma) with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations or alterations Key
- Cancer that has a known MEK1/2 mutation.
- Known allergy/hypersensitivity to excipients of S241656 or to any of the registered IMPs administered in combination.
- Any contra-indication, to use of any of the combination chemotherapy or anti-EGFR therapy partners administered as part of this trial.
- Major surgery within 4 weeks of study entry or planned during study.
- Ongoing anticancer therapy.
- Ongoing radiation therapy.
- Uncontrolled or active clinically relevant bacterial, fungal, or specific viral infection requiring systemic therapy.
- Clinically significant cardiovascular disease.
- Symptomatic spinal cord compression.
- Evidence of active malignancy (other than study-specific malignancies) requiring systemic therapy within the next 2 years.
- History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.
- Females who are pregnant or breastfeeding.
- Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.
- Prior use of experimental agents that target the KRAS/BRAF/MEK/ERK pathway.
The study team makes the final eligibility decision.
Where it is enrolling
- Gilbert, Arizona, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- New Haven, Connecticut, United States
- Boston, Massachusetts, United States
- Grand Rapids, Michigan, United States
- Minneapolis, Minnesota, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
- Seattle, Washington, United States
- Beijing, China
- Jinan, China
- Suzhou, China
- Copenhagen, Denmark
+ 10 more site(s).
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, but 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Gilbert, Arizona, United States; Los Angeles, California, United States; San Francisco, California, United States; New Haven, Connecticut, United States; Boston, Massachusetts, United States; Grand Rapids, Michigan, United States and 24 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.