ClinicaliQ Trial Snapshot
- A Phase I Study of BAY3498264 Given Together With Sotorasib in Participants Who Have Advanced Solid Cancers With Specific Genetic Changes Called KRASG12C Mutation — Recruiting • Phase I • Oncology • NCT06659341.
- What is being tested: BAY3498264 combined with sotorasib in patients with advanced solid cancers carrying KRASG12C mutations, investigating whether combination therapy improves efficacy beyond sotorasib monotherapy.
- Patient eligibility overview: Adults with advanced/metastatic solid tumours harbouring KRASG12C mutations who are treatment-Phase Iïve or previously treated; specific performance status and organ function criteria apply.
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What This Trial Is Studying
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…
Eligibility Snapshot
- : * Histologically confirmed solid tumor malignancy with documented KRAS^G12C mutation as assessed by an appropriately accredited laboratory. * Documented disease progression after treatment with at least 1 prior standard of care (SoC) systemic therapy other than a G12C inhibitor for locally advanced or metastatic disease, and with no further standard treatment options available, or when standard treatment options are not acceptable and this study is a reasonable option. * 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.