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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)

This open-label, exploratory study is designed to evaluate the safety and efficacy of
targeted therapies or immunotherapy 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.
Colon, Phase I, Rectal
Phase I
Chemotherapy - cytotoxic, Mol. targeted/Immunotherapy/Biologics
Atezolizumab, Bevacizumab, Cetuximab, Divarasib (GDC-6036), FOLFOX, SY-5609, Tiragolumab
Ciombor, Kristen
Vanderbilt University


18 Years
Inclusion Criteria:

Signed cohort-specific Informed Consent Form

Age >= 18 years at time of signing Informed Consent Form

Biomarker eligibility as determined at a College of American Pathologists/clinical laboratory improvement amendments (CAP/CLIA)-certified or equivalently accredited diagnostic laboratory using a validated test

Eastern Cooperative Oncology Group (ECOG) Performance Status of = 1

Life expectancy >= 3 months, as determined by the investigator

Histologically confirmed adenocarcinoma 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 patients 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

Exclusion Criteria:

Current participation or enrollment in another interventional clinical trial. Patients who are participating in the follow-up period of an interventional clinical trial are eligible for the study.

Any systemic anti-cancer treatment within 2 weeks or 5 half-lives (whichever is shorter) prior to start of study treatment

Treatment with investigational therapy within 28 days prior to initiation of study treatment

Pregnant or breastfeeding, or intending to become pregnant during the study

History of or concurrent serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study or confounds the ability to interpret data from the study

Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety

Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or efficacy of study treatment

Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)

Uncontrolled tumor-related pain

Uncontrolled or symptomatic hypercalcemia

Clinically significant and active liver disease

Negative HIV test at screening, with the following exception: Patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count greater than or equal to 200/uL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months.

Symptomatic, untreated, or actively progressing CNS metastases

History of leptomeningeal disease or carcinomatous meningitis

History of malignancy other than CRC within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death

Any other disease, unresolved toxicity from prior therapy, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications

Requirement for treatment with any medicinal product that contraindicates the use of any of the study treatments, may interfere with the planned treatment, affects patient compliance, or puts the patient at higher risk for treatment-related complications

To learn more about any of our clinical
trials, call 615-936-8422.