Using 177Lu-DOTA-EB-TATE for treating advanced neuroendocrine tumors
Phase I, Open-Label Study of the Safety and Dosimetry of a 3-Dose Regimen of Escalating Doses of 177Lu-DOTA-EB-TATE in Adult Patients With Advanced, Well- Differentiated Neuroendocrine Tumors
This study is testing a new treatment called 177Lu-DOTA-EB-TATE to see if it is safe and effective for adults with advanced neuroendocrine tumors that can't be removed by surgery.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 9 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Molecular Targeting Technologies, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05475210 on ClinicalTrials.gov |
What this trial studies
This Phase I clinical trial evaluates the safety and dosimetry of 177Lu-DOTA-EB-TATE in adult patients with advanced, metastatic, or inoperable neuroendocrine tumors that express somatostatin receptors. Participants will receive the treatment alongside an amino acid solution, and the study aims to determine the appropriate dosage and safety profile of this intervention. The trial includes patients with well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs) who meet specific eligibility criteria, including measurable disease and adequate kidney function.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed, inoperable, somatostatin receptor-positive GEP-NETs.
Not a fit: Patients with neuroendocrine tumors that do not express somatostatin receptors or those with other types of tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced neuroendocrine tumors.
How similar studies have performed: Other studies have shown promise with similar radiolabeled therapies for neuroendocrine tumors, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Ability to understand and willing to sign a written informed consent document Aged 18 years or older Histologically proven or cytologically confirmed, inoperable, GEP-NETs Neuroendocrine tumors (NETs) of grade 1, 2 and 3 according to World Health Organization (WHO) 2017 classification Measurable disease as defined by Response Criteria in Solid Tumors (RECIST) version 1.1 Overexpression of somatostatin receptors of the target lesions in 68Ga-DOTA-TATE positron emission tomography (PET)/computed tomography (CT) with SUV of lesions greater than normal liver in at least 1 lesion A Cockcroft Gault calculated creatinine clearance \> 60 mL/min Karnofsky performance status scale ≥ 70% Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation, including follow-up (7 months after the last dose of study drug for women and 4 months for men). Previous local therapy (e.g., chemoembolization or bland embolization) is allowed if completed \>4 weeks prior to study entry. Previous surgery no less than 6 weeks prior to study entry. Either no prior treatment with 177Lu-DOTA-TATE or at least 12 months progression-free survival (PFS) after prior treatment with 177Lu-DOTA-TATE Exclusion Criteria: Women who are pregnant or breastfeeding History of allergic reactions attributed to compounds of similar chemical or biologic composition to 177Lu-DOTA-EB-TATE as assessed from medical records Previous treatment with more than 4 cycles of 177Lu-DOTA-TATE Participant has had prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent within 4 weeks or 4 half-lives whichever is longer, before the first administration of study drug. Participant has not fully recovered from major surgery or significant traumatic injury prior the first dose of study drug or expects to have major surgery during the study period or within 3 months after the last dose of study drug. Life expectancy \< 6 months as assessed by the treating physician \> 80% liver involvement by tumor \> 25% bone marrow involvement by tumor Poorly differentiated neuroendocrine neoplasms, such as poorly differentiated neuroendocrine carcinoma, small- and large-cell neuroendocrine carcinoma; mixed neuroendocrine-non-neuroendocrine neoplasm (MiNEN); Grade 3 neuroendocrine carcinomas (NEC) Presence of somatostatin receptor negative lesions if they cannot be addressed with loco-regional therapies prior to the treatment start Deteriorated renal function, as indicated by a serum creatinine clearance \> 1.7 mg/dL Deteriorated bone marrow function Deteriorated liver function Toxicities from prior therapies that have not resolved to grade 1 or grade 0 Active and clinically significant bacterial, fungal, or viral infection, including hepatitis B (HBV), hepatitis C (HBC), know human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness Known brain metastases and/or carcinomatous meningitis, unless these metastases have been treated and stabilized Uncontrolled diabetes mellitus as defined by a HbA1c \>9% Impossibility to interrupt short-acting octreotide for 24 h before and 24 h after the administration of 177Lu-DOTA-EB-TATE; impossibility to have an interval of ≥4 weeks between octreotide and 177Lu-DOTA-EB-TATE The use of somatostatin and its analogues within 4 months of a planned 177Lu-DOTA-EB-TATE treatment Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Prior external beam radiation therapy involving \>25% of the bone marrow Unmanageable urinary incontinence rendering the administration of 177Lu-DOTA-EB-TATE unsafe Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and with no evidence of recurrence
Where this trial is running
New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Lisa Bodei, MD, PhD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Chris Pak
- Email: cpak@mtarget.com
- Phone: 610-738-7938
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.