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New treatment option for Advanced Solid Tumors Harboring KRAS G12C Mutation
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
ClinicalTrials.gov ID: NCT06659341
What this study is testing
What is BAY3498264?
BAY3498264 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced solid tumors harboring kras g12c mutation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Adequate archival formalin-fixed paraffin-embedded tumor tissue available (preferably no older than 6 months, obtained after the last targeted...
You likely can't join if
- \- 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...
- Any grade active pneumonitis or interstitial lung disease (ILD), or past medical history of:
- Grade ≥2 ILD,
- Drug-induced ILD,
See the full eligibility criteria
- 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...
- 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...
- Eastern Cooperative Oncology Group (ECOG) of 0 to 2 and life expectancy of at least 12 weeks.
- \- 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...
- Any grade active pneumonitis or interstitial lung disease (ILD), or past medical history of:
- Grade ≥2 ILD,
- Drug-induced ILD,
- Radiation pneumonitis that required steroid treatment within the last 12 months.
- Additional malignancy within the past 3 years, except for basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder tumors, localized prostate cancer or other tumors that in the...
- Any positive test result for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating the presence of virus.
- Active HBV (chronic or acute; defined as having a known positive HBsAg test at the time of screening) except for participants on antiviral therapy for HBV with an undetectable or low viral load.
- Participants with past HBV infection or resolved HBV infection (defined as the presence of HBcAb and absence of HBsAg) are eligible if HBV DNA is negative.
- Participants positive for HCV antibody unless polymerase chain reaction is negative for HCV RNA. Any prior antiviral therapy must be completed at least 28 days before the first dose of study intervention.
The study team makes the final eligibility decision.
Where it's taking place
- Albury, New South Wales, Australia
- Macquarie Park, New South Wales, Australia
- Frankston, Victoria, Australia
- Copenhagen, Capital Region, Denmark
- Rome, Lazio, Italy
- Rozzano, Italy
- L'Hospitalet de Llobregat, Barcelona, Spain
- Barcelona, Spain
- Manchester, Greater Manchester, United Kingdom
- Sutton, Surrey, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Albury, New South Wales, Australia; Macquarie Park, New South Wales, Australia; Frankston, Victoria, Australia; Copenhagen, Capital Region, Denmark; Rome, Lazio, Italy; Rozzano, Italy and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.