Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07318805
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older
* Advanced or metastatic cancer of the breast or colon Part 1A: metastatic or advanced breast cancer or colorectal cancer for which no standard therapy is available Part 1B: metastatic or advanced breast cancer with disease progression after at least 1 line of treatment with an endocrine therapy and CDK4/6 inhibitor in the advanced or metastatic setting Part 1C: metastatic or advanced colorectal cancer with at least having received chemotherapy and/or targeted therapy if appropriate Part 1D: metastatic or advanced colorectal cancer without any prior chemotherapy for advanced or metastatic disease Part 2A: metastatic or advanced breast cancer with disease progression after at least 1 prior line of CDK4/6 inhibitor and at least 1 prior line of endocrine therapy Part 2B: metastatic or advanced colorectal cancer with at least having received chemotherapy and/or targeted therapy if appropriate Part 2C: metastatic or advanced colorectal cancer without any prior chemotherapy for advanced or metastatic disease
* Measurable disease
* ECOG performance status 0 or 1
Exclusion Criteria:
* Active malignancy within 3 years prior to enrollment
* Known symptomatic brain metastases requiring steroids
* Advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term
* Prior irradiation to \>25% of the bone marrow
* Hypertension that cannot be controlled by optimal medical therapy
* Renal impairment
* Hepatic dysfunction
* Cardiac abnormalities
* Active bleeding disorder
* Active or history of clinically significant GI disease
* Other unacceptable abnormalities as defined by protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07318805
Study Brief:
Protocol Section:
NCT07318805