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New treatment option for Non-small Cell Lung Cancer
Official title Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT06343402
What this study is testing
What is BBO-8520?
BBO-8520 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for non-small cell lung cancer.
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
- A first in human study to evaluate the safety and preliminary antitumor activity of BBO-8520, a KRAS G12C (ON and OFF) inhibitor, as a single agent and in combination with pembrolizumab and BBO-10203 in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation.
- Phase 1: an early, usually small safety study
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
- Histologically documented locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS G12C mutation
- Measurable disease by RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
You likely can't join if
- Patients with malignancy within the last 2 years as specified in the protocol
- Patients with untreated or unstable brain metastases
- Patients with known hypersensitivity to BBO-8520 or its excipients
- For Cohorts 1b and 2b:
- Patients with a known hypersensitivity to pembrolizumab or its excipients
- Patients with active autoimmune disease of history of autoimmune disease that might recur
See the full eligibility criteria
- Histologically documented locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS G12C mutation
- Measurable disease by RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
- Patients with malignancy within the last 2 years as specified in the protocol
- Patients with untreated or unstable brain metastases
- Patients with known hypersensitivity to BBO-8520 or its excipients
- For Cohorts 1b and 2b:
- Patients with a known hypersensitivity to pembrolizumab or its excipients
- Patients with active autoimmune disease of history of autoimmune disease that might recur
- Patients with a history of interstitial lung disease/pneumonitis that required steroids, or current interstitial lung disease/pneumonitis Other inclusion/exclusion criteria may apply
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- La Jolla, California, United States
- San Francisco, California, United States
- Santa Monica, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Norwalk, Connecticut, United States
- Peoria, Illinois, United States
- Kansas City, Kansas, United States
- Detroit, Michigan, United States
- Buffalo, New York, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Eugene, Oregon, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Waco, Texas, United States
- Salt Lake City, Utah, United States
- Fairfax, Virginia, United States
- Seattle, Washington, United States
+ 13 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 - 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?
Study sites include Birmingham, Alabama, United States; La Jolla, California, United States; San Francisco, California, United States; Santa Monica, California, United States; Aurora, Colorado, United States; New Haven, Connecticut, United States and 27 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 ClinicalTrials.gov; the study team decides eligibility.