MC# 21-40 - Dose Escalation and Expansion Clinical Study to Evaluate the Safety and Efficacy of ELU001 in Subjects Who Have Advanced, Recurrent or Refractory FRα Overexpressing Tumors
Disease Type(s): Colorectal, Endometrial, Gastric, Ovarian, Lung-NSCLC, Cholangiocarcinoma, Breast- Triple Negative, Gastroesophageal Junction
Drug Classification(s): Cytotoxic Therapy, Targeted Therapy
Molecular Target(s): Folate Receptor (FR)
Mechanism of Action
ELU001 is a 7 nm size silica particle that has attached folate molecules to bind to cells with folate receptor in order to deliver the attached cytotoxic payload molecules.
In this study, the sponsor and investigators want to learn:
- How much of ELU001 can be given with an acceptable level of side effects
- The effects of ELU001 (good and bad)
- How much of ELU001 is absorbed into the blood and how fast it is removed
- If research tests can be used in the future to predict who will benefit from ELU001
- 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 (FRα) expression analysis
- Adequate organ function
- In Part 1, measurable disease or, in the absence of measurable disease, non-measurable disease (lesions considered truly non-measurable include leptomeningeal disease, ascites, pleural or pericardial effusion, inflammatory breast disease, lymphangitic involvement of skin or lung, abdominal masses/abdominal organomegaly identified by physical exam that is not measurable by reproducible imaging techniques), as per RECIST v1.1. In Part 2, measurable disease (only), as per RECIST v1.1. Note – A lytic or mixed lytic-blastic bone lesion with a soft tissue component assessed on CT/MRI can be measurable if the minimum size criteria are met. For other criteria, refer to 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
- Active or ongoing eye disorders
- Taken any treatments that use the protein folate receptor alpha or FRα 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").
- QTcF > 470 ms within 4 weeks prior to the first dose of study drug
- Dallas, TX - Mary Crowley Cancer Research - Medical City