RecruitingPhase 1interventionalRules rewrite

Phase 1: testing BAY3498264 for Advanced Solid Tumors Harboring KRAS G12C Mutation

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.

Official registry: https://clinicaltrials.gov/study/NCT06659341 · Bayer · enrollment listed as 104

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are BAY3498264. The registry lists allocation as randomized. Researchers are looking for a better way to treat people who have advanced solid cancers with a KRASG12C mutation.

They plan to enroll about 104 people at 11 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Phase 1 Study of a SOS1 Inhibitor, BAY 3498264, in Combination in Participants With Advanced KRASG12C-mutated Solid Tumors

Interventions: BAY3498264

Primary outcome (registry wording): Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) categorized by severity.

Who it is for (from inclusion criteria)

Ages 18 Years to any
Histologically confirmed solid tumor malignancy with documented KRAS\^G12C mutation as assessed by an appropriately accredited laboratory
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

Who the registry excludes

\- Active central nervous system (CNS) tumors including metastatic brain disease, at the time of screening
'Active' is defined as untreated brain lesions (new or progressing) or symptomatic brain lesions (as determined by the investigator)
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:
Radiation pneumonitis that required steroid treatment within the last 12 months

Public study contact (from the registry)

Bayer Clinical Trials Contact

0018888422937

clinical-trials-contact@bayer.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

11 listed

Border Medical oncology - Albury Wodonga Regional Cancer Centre — Albury, New South Wales, Australia (recruiting)
Macquarie University Hospital - Oncology Department — Macquarie Park, New South Wales, Australia (recruiting)
Peninsula and Southeast Oncology — Frankston, Victoria, Australia (recruiting)
Cabrini Health Oncology Research — Malvern, Victoria, Australia (withdrawn)
Rigshospitalet Copenhagen University Hospital | Oncology Department — Copenhagen, Capital Region / Region Hovedstaden, Denmark (recruiting)
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica — Rome, Lazio, Italy (recruiting)
Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia — Rozzano, Lombardy, Italy (recruiting)
Hospital Universitari Vall D Hebron | Oncologia — Barcelona, Spain (recruiting)
Institut Catala D'oncologia | Hospitalet | Oncologia — Barcelona, Spain (recruiting)
The Christie Hospital | Oncology — Manchester, Greater Manchester, United Kingdom (recruiting)
The Royal Marsden (Surrey) | Oak Foundation Drug Development Unit — Sutton, Surrey, United Kingdom (recruiting)

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FAQ about this NCT record

Is NCT06659341 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06659341?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06659341?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary