New drug takes on KRAS: early trial launches for Hard-to-Treat cancers
NCT ID NCT04111458
First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 2 times
Summary
This early-stage study tests a new drug called BI 1701963, which blocks a cancer-driving protein called KRAS. It is given alone or with an approved drug, trametinib, to adults with advanced solid tumors that have a KRAS mutation and have not responded to prior chemotherapy. The main goals are to find a safe dose and see if the combination can shrink tumors.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- BI 1701963 (a KRAS-blocking drug) and trametinib (a MEK inhibitor)
- What this could lead to
- If it works, this could point toward a new treatment option for people with advanced cancers that have a KRAS mutation.
- What could go wrong
- This is a very early (Phase 1) trial testing a new drug in humans for the first time. The drug may not shrink tumors or could cause serious side effects. Success is far from guaranteed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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Erasmus Medisch Centrum-ROTTERDAM-50697
Rotterdam, 3015 GD, Netherlands
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Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
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Sarah Cannon Research Institute-Nashville-48456
Nashville, Tennessee, 37203, United States
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The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX, Netherlands
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Universitätsklinikum Frankfurt
Frankfurt am Main, 60590, Germany
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Universitätsklinikum Köln (AöR)
Cologne, 50937, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new immunotherapy combo outsmart advanced lung cancer?
- Double attack on mutant KRAS: can two targeted drugs outsmart resistant cancers?
- Seeing the fight: new imaging tracer may reveal how immune cells attack lung cancer
- Could a bronchial wash detect lung cancer mutations faster?
- Can a targeted pill outsmart a tough lung cancer mutation?
- Can a PET scan reveal hidden heart harm from lung cancer treatment?