Actively Recruiting
Phase 1 Study of BAY3498264, a SOS1 Inhibitor, Combined With Sotorasib in Participants With Advanced KRASG12C-mutated Solid Tumors
Led by Bayer · Updated on 2026-05-12
104
Participants Needed
10
Research Sites
20 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating treatments for people with advanced solid tumors that have a specific genetic change called the KRASG12C mutation. This trial studies BAY3498264, a drug designed to block a protein called SOS1 that works with KRAS, alongside sotorasib, an already approved drug targeting KRASG12C. The goal is to find out how safe BAY3498264 is when combined with sotorasib and to determine the highest safe dose of BAY3498264 for patients. Participants will start by receiving BAY3498264 alone for seven days, followed by cycles of BAY3498264 combined with sotorasib every 21 days. Sotorasib is taken once daily at a standard approved dose. The study has three parts: dose escalation to find the best dose, backfill cohorts to gather more safety and drug data, and expansion cohorts for additional testing. Treatment continues as long as it helps without serious problems or until cancer progresses or the patient or doctor decides to stop. Throughout the study, participants will have blood and urine samples collected and undergo imaging scans like CT, PET, MRI, and X-rays. Heart health is monitored using electrocardiograms. Researchers will track safety by recording side effects, measure drug levels in the body, and assess cancer response regularly. Monitoring continues through treatment cycles and after the last dose to ensure participant safety and treatment effects are carefully observed.
CONDITIONS
Brief 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...
- Have a solid tumor confirmed by tissue testing to have a KRASG12C mutation
- Have experienced disease progression after at least one prior standard systemic therapy for advanced or metastatic disease
- Have no further acceptable standard treatment options or standard treatments are not suitable
- May have received prior KRASG12C inhibitor treatment but with disease progression or intolerance
- Have available tumor tissue sample for testing, preferably recent
- Have an ECOG performance status of 0 to 2
- Have a life expectancy of at least 12 weeks
You will not qualify if you...
- Have active central nervous system tumors or untreated brain metastases at screening
- Have residual neurological symptoms above mild level from brain metastases
- Require systemic corticosteroids for brain metastasis symptoms
- Have active pneumonitis or interstitial lung disease, or a history of severe lung inflammation
- Have had another cancer within the past 3 years except certain skin, cervical, bladder, or localized prostate cancers considered cured or not life-threatening
- Have active hepatitis B or C infection, or positive tests indicating presence of these viruses without appropriate treatment or clearance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 7 days
Participants receive BAY3498264 monotherapy for 7 days as a safety run-in before starting combination treatment.
1 visit (in-person) during this period
Duration - Repeated 21-day treatment cycles until disease progression or discontinuation
Participants are treated with BAY3498264 combined with sotorasib in repeated cycles. Dose escalation and intra-participant dose adjustments may occur based on safety and tolerance.
Visits every 21 days aligned with treatment cycles; tumor assessments every 6 weeks for first 36 weeks, then every 9 weeks until disease progression
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
Frequently Asked Questions
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