New combo aims to boost existing cancer Drug's power
NCT ID NCT06659341
First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 4 times
Summary
This early-phase study tests a new experimental drug, BAY 3498264, combined with the approved cancer drug sotorasib in people with advanced solid tumors that have a specific KRAS G12C mutation. The goal is to find a safe dose and see if the combination can make sotorasib work longer or better. About 104 participants will receive the drugs in cycles, and researchers will monitor side effects, drug levels, and tumor response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BAY 3498264 (a SOS1 inhibitor) combined with sotorasib
- What this could lead to
- If successful, this combination could extend the time that sotorasib works in people with KRAS G12C cancers, potentially leading to longer disease control.
- What could go wrong
- This is a very early Phase 1 trial with only 104 participants. The main goal is safety and dosing, not proof of effectiveness. The combination may cause unexpected side effects or fail to improve outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 104 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically confirmed solid tumor malignancy with documented KRAS\^G12C mutation as assessed by an appropriately accredited laboratory. * Documented disease progression after treatment with at least 1 prior standard of care (SoC) systemic therapy other than a G12C inhibitor for locally advanced or metastatic disease, and with no further standard treatment options available, or when standard treatment options are not acceptable and this study is a reasonable option. * Participants whose access to SoC therapies is limited due to regional access, refusal, intolerance, or eligibility may participate. * Prior G12C inhibitor treatment is permitted. Participants receiving prior G12C inhibitor therapy must have documented disease progression after treatment, or have discontinued that treatment due to intolerance. * Adequate archival formalin-fixed paraffin-embedded tumor tissue available (preferably no older than 6 months, obtained after the last targeted therapy). If archival material is not available, a fresh tumor biopsy should ideally be obtained if safe and feasible. * Eastern Cooperative Oncology Group (ECOG) of 0 to 2 and life expectancy of at least 12 weeks. Exclusion Criteria: \- Active central nervous system (CNS) tumors including metastatic brain disease, at the time of screening. 1. 'Active' is defined as untreated brain lesions (new or progressing) or symptomatic brain lesions (as determined by the investigator). 2. Participants who have received treatment (e.g. surgery or radiotherapy) for brain metastases ending at least 4 weeks before the start of study intervention may be eligible if, at the point of study entry: i. their condition is considered stable by the investigator. ii. they have no residual neurological symptoms (Grade \>2). iii. a follow-up Magnetic resonance imaging (MRI) scan during the screening period shows no progression or new lesions. iv. they do not need systemic corticosteroids to treat symptoms of brain metastasis. * Any grade active pneumonitis or interstitial lung disease (ILD), or past medical history of: 1. Grade ≥2 ILD, 2. Drug-induced ILD, 3. Radiation pneumonitis that required steroid treatment within the last 12 months. * Additional malignancy within the past 3 years, except for basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder tumors, localized prostate cancer or other tumors that in the opinion of the investigator, in agreement with the Sponsor, are considered cured or not immediately life-threatening, and will not interfere with the scientific goals of this study. * Any positive test result for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating the presence of virus. * Active HBV (chronic or acute; defined as having a known positive HBsAg test at the time of screening) except for participants on antiviral therapy for HBV with an undetectable or low viral load. * Participants with past HBV infection or resolved HBV infection (defined as the presence of HBcAb and absence of HBsAg) are eligible if HBV DNA is negative. * Participants positive for HCV antibody unless polymerase chain reaction is negative for HCV RNA. Any prior antiviral therapy must be completed at least 28 days before the first dose of study intervention.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites in 5 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Border Medical oncology - Albury Wodonga Regional Cancer Centre
RECRUITINGAlbury, New South Wales, 2640, Australia
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
RECRUITINGRoma, 00168, Italy
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Hospital Universitari Vall D Hebron | Oncologia
RECRUITINGBarcelona, 08035, Spain
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Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia
RECRUITINGRozzano, 20089, Italy
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Institut Catala D'oncologia | Hospitalet | Oncologia
RECRUITINGBarcelona, 8907, Spain
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Macquarie University Hospital - Oncology Department
RECRUITINGMacquarie Park, New South Wales, 2109, Australia
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Peninsula and Southeast Oncology
RECRUITINGFrankston, Victoria, 3199, Australia
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Rigshospitalet Copenhagen University Hospital | Oncology Department
RECRUITINGCopenhagen, Capital Region / Region Hovedstaden, 2100, Denmark
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Royal Marsden NHS Trust (Surrey)
RECRUITINGSutton, Surrey, SM2 5PT, United Kingdom
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The Christie Hospital | Oncology
RECRUITINGManchester, Greater Manchester, M20 4BX, United Kingdom