RecruitingPhase 1NCT06659341

A Phase I Study of BAY3498264 Given Together With Sotorasib in Participants Who Have Advanced Solid Cancers With Specific Genetic Changes Called KRASG12C Mutation

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


Sponsor

Bayer

Enrollment

104 participants

Start Date

Nov 8, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called BAY3498264 for people with advanced solid tumors harboring kras g12c mutation. The study is currently recruiting participants at 10 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBAY3498264

Oral


Locations(10)

Border Medical oncology - Albury Wodonga Regional Cancer Centre

Albury, New South Wales, Australia

Macquarie University Hospital - Oncology Department

Macquarie Park, New South Wales, Australia

Peninsula and Southeast Oncology

Frankston, Victoria, Australia

Rigshospitalet Copenhagen University Hospital | Oncology Department

Copenhagen, Capital Region, Denmark

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica

Rome, Lazio, Italy

Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia

Rozzano, Italy

Institut Catala D'oncologia | Hospitalet | Oncologia

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitari Vall D Hebron | Oncologia

Barcelona, Spain

The Christie NHS Foundation Trust - Christie Hospital

Manchester, Greater Manchester, United Kingdom

The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH) - Sutton

Sutton, Surrey, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06659341