Actively Recruiting
A Phase I Study of BAY3498264 Given Together With Sotorasib in Participants Who Have Advanced Solid Cancers With Specific Genetic Changes Called KRASG12C Mutation
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 looking for a better way to treat people who have advanced solid cancers with a KRASG12C mutation. Sotorasib is a drug that targets cancer cells which contain mutated KRASG12C protein; it can stop the cancer cells from growing and can lead to their death. Sotorasib is already approved to be used by doctors. However, when sotorasib works, it normally only works for a period of time, after which the cancer starts to grow again, and the patient may need a different treatment. BAY3498264 is a drug that is currently under development. It is expected to prevent the activity of a protein called son of sevenless 1 (SOS1). The SOS1 protein works together with KRAS; by blocking the activity of SOS1 with BAY3498264, it is hoped that the benefit offered by treatment with sotorasib may be increased - for example, resulting in a longer or deeper response. The main purpose of this first-in-human study is to learn how safe BAY3498264 is when given together with sotorasib and what is the maximum dose of BAY3498264 that can be safely given to participants together with sotorasib. During the study, participants will receive the following treatments: * BAY3498264: participants will first receive BAY3498264 alone for seven days and then BAY3498264 in combination with sotorasib. These combination treatments will be given in cycles, each lasting 21 days. * Sotorasib: participants will receive a standard, approved dose of Sotorasib once every day with BAY3498264. The treatment will continue for as long as participants benefit from it without any severe medical problems or until they or their doctor decide to stop the treatment, or until their cancer starts to grow again despite the treatment (also called 'progression'). This study has 3 parts, the dose escalation part, the backfill part and the expansion part. During the study, researchers will collect blood, urine, and take imaging scans like CT, PET, MRI, and X-rays, and examine the participants' heart health using an electrocardiogram (ECG). Participants' health is monitored throughout the study.
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
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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