Brief Summary
This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapya treatment that uses a person's immune system to fight cancer as single agents or combinations, in participants with metastatic colorectalrelating to the colon or rectum in the large bowel/intestine cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results.
Intervention / Treatment
- Drug: Inavolisib
- Drug: Bevacizumab
- Drug: Cetuximab
- Drug: Atezolizumab
- Drug: Tiragolumab
- Drug: SY-5609
- Drug: Divarasib
- Drug: FOLFOX
- Drug: FOLFIRI
Inclusion Criteria
- Signed cohort-specific Informed Consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. Form
- Age >= 18 years at time of signing Informed Consent Form
- Biomarker eligibility as determined by:
- A validated test approved by local health authorities for detection of the specified biomarkers/mutations.
- A validated test performed at a College of American Pathologists/clinical laboratory improvement amendments (CAP/CLIA) -certified or equivalently accredited diagnostic laboratory using a validated test for detection of the specified biomarkers.
- Prior test results completed before signing cohort-specific Informed Consent Form or local test results generated prior to or during screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening, and availability of a full report of the testing results OR
- Blood-based FoundationOne Liquid CDx biomarker eligibility test result generated prior to or during screening or, in case of re-enrollment after treatment discontinuation, prior to starting a new anti-cancer therapy.
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) Performance Status of <= 1
- Life expectancy >= 3 months, as determined by the investigator
- Histologically confirmed adenocarcinomacancer arising from mucus-producing glands in organs originating from the colonthe longest portion of the large bowel that absorbs water and salts from ingested food or rectumthe last section of the large intestine/bowel that holds waste until it is ready to be removed from the body
- Metastatic disease
- Prior therapies for metastatic disease
- Ability to comply with the study protocol, in the investigators judgment
- Measurable disease (at least one target lesion) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
- Baseline tumor tissuea group of cells that work together to perform a function samples will be collected from all participants for exploratory biomarker research
- Adequate hematologic and organ function within 14 days prior to initiation of study treatment
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures
- For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm