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 colorectal cancer (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 Consent 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 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 Oncology 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 colon or rectum
- 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 tissue 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