Actively Recruiting
Phase 1 Study of BAY3498264 with Sotorasib for Advanced Solid Tumors With KRASG12C Mutation Evaluating Safety, Dosage, and Treatment Response
Led by Bayer · Updated on 2026-05-12
104
Participants Needed
10
Research Sites
133 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating new treatment options for adults with advanced solid tumors that have a KRASG12C mutation. This mutation causes cancer cells to grow, and while the drug sotorasib is approved to target these cancer cells, it usually works only for a limited time before the cancer grows again. The study is testing BAY3498264, a drug designed to block a protein called SOS1 that works with KRAS, hoping this will enhance the effects of sotorasib by providing a longer or stronger response. This is a first-in-human Phase 1 study focusing on the safety and best dosing of BAY3498264 when combined with sotorasib. Participants will first take BAY3498264 alone for seven days, then receive it together with sotorasib in repeated 21-day cycles. Sotorasib is given daily at a standard approved dose alongside BAY3498264. Treatment will continue as long as it benefits participants without causing severe side effects, or until the cancer progresses, or if the participant or doctor decides to stop. The study consists of three parts: dose escalation, backfill, and expansion to determine safe dosing and to monitor effects. Throughout the study, participants will have blood and urine samples collected and undergo imaging scans such as CT, PET, MRI, and X-rays. Their heart health will be checked using ECGs. Researchers will closely monitor safety by tracking any side effects, serious adverse events, drug levels in the blood, and any toxicities during the first treatment cycle. The study will last approximately three years to assess the maximum tolerated dose and overall safety of the drug combination.
CONDITIONS
Official Title
A Phase I Study of BAY3498264 Given Together With Sotorasib in Participants Who Have Advanced Solid Cancers With Specific Genetic Changes Called KRASG12C Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed solid tumor with KRAS G12C mutation verified by an accredited lab.
- Disease progression after at least one prior standard systemic therapy (not including G12C inhibitors) for locally advanced or metastatic cancer, with no further standard treatment options or when this study is a reasonable option.
- Participants with limited access to standard therapies or who refused or could not tolerate them may participate.
- Prior treatment with KRAS G12C inhibitors is allowed if disease progressed afterward or treatment was stopped due to intolerance.
- Adequate tumor tissue available from recent biopsy or archival sample preferably no older than 6 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Life expectancy of at least 12 weeks.
You will not qualify if you...
- Active central nervous system tumors including untreated or progressing brain metastases at screening.
- Brain metastases treated at least 4 weeks before study start but must be stable, without significant neurological symptoms, no progression on MRI, and no need for systemic corticosteroids.
- Active pneumonitis or interstitial lung disease (ILD), or history of grade 2 or higher ILD, drug-induced ILD, or radiation pneumonitis requiring steroids in the last 12 months.
- Additional malignancies within the past 3 years except certain skin cancers, cervical carcinoma in situ, superficial bladder tumors, localized prostate cancer, or other tumors considered cured or not life-threatening.
- Positive test for hepatitis B or hepatitis C virus indicating active infection unless on antiviral therapy with undetectable or low viral load.
- Participants positive for hepatitis C antibody must have negative RNA PCR and completed antiviral therapy at least 28 days before study start.
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Border Medical oncology - Albury Wodonga Regional Cancer Centre
Albury, New South Wales, Australia, 2640
Actively Recruiting
2
Macquarie University Hospital - Oncology Department
Macquarie Park, New South Wales, Australia, 2109
Actively Recruiting
3
Peninsula and Southeast Oncology
Frankston, Victoria, Australia, 3199
Actively Recruiting
4
Rigshospitalet - Kræftbehandling
Copenhagen, Capital Region, Denmark, 2100
Actively Recruiting
5
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
Rome, Lazio, Italy, 00168
Actively Recruiting
6
Gruppo Humanitas - Humanitas Research Hospital - Cancer Center
Rozzano, Italy, 20089
Actively Recruiting
7
Institut Catala D'oncologia | Hospitalet | Oncologia
L'Hospitalet de Llobregat, Barcelona, Spain, 8907
Actively Recruiting
8
Hospital Universitari Vall D Hebron | Oncologia
Barcelona, Spain, 08035
Not Yet Recruiting
9
The Christie NHS Foundation Trust - Christie Hospital
Manchester, Greater Manchester, United Kingdom, M20 4BX
Actively Recruiting
10
The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH) - Sutton
Sutton, Surrey, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
B
Bayer Clinical Trials Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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