Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Key Inclusion Criteria:
Patients must meet the following criteria to enroll in this study:
- Documented diagnosis of ovarian cancer, endometrial cancer, colorectal cancer, gastric
cancer, gastroesophageal junction cancer, triple negative breast cancer, non-small
cell lung cancer, or cholangiocarcinoma
- No other meaningful life-prolonging therapy option available
- Must provide archival tumor tissue or a newly obtained tumor biopsy specimen prior to
the first dose of ELU001 for folate receptor alpha (FR?) expression analysis
- Adequate organ function
- Measurable disease, or in the absence of measurable disease, non-measurable disease as
per Response evaluation criteria in solid tumors (RECIST) v1.1
- Part 1: Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2;
Part 2: ECOG performance status of 0 or 1.
- Recovered from previous surgeries
- Agree to highly effective contraception, not to get pregnant, or for men, not father a
child during study participation
Key Exclusion Criteria:
Patients who meet any of the following are not eligible to enroll in this study:
- Active or ongoing eye disorders
- Taken any treatments that use the protein folate receptor alpha or FR? to work
- Taken any other experimental treatments
- History of significant cardiac issues or other cancers within 3 years.
- Significant anemia, significant neutropenia, or significant thrombocytopenia (e.g.,
not enough platelets in your blood - platelets held stop bleeding in your body)
- Detectable viral load for HIV (human immunodeficiency virus), hepatitis B or C.
- If you are pregnant.
- Part 1: Cannot have active autoimmune diseases such as rheumatoid arthritis, SLE
(systemic lupus erythematosus), ulcerative colitis, Crohn's Disease, MS (multiple
sclerosis), ankylosing spondylitis, thyroiditis that require treatments that suppress
your immune system.
- Part 1: if your cancer has spread to your brain.
- Part 2: You can have cancer that has spread to your brain but there are exceptions.
The cancer in your brain cannot be causing any symptoms, it cannot be larger than 3
cm, there can be no evidence on a scan that shows your brain tissue has shifted from
its expected position inside the skull (called "herniation") or be bleeding in the
skull or brain itself (called "hemorrhage").
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 6/27/23. Questions regarding updates should be directed to the study team contact.