177Lu-DOTA-EB-TATE in Untreated (Naïve) Adult Patients With Advanced, Well- Differentiated Neuroendocrine Tumors

Study Purpose

This is a Phase I clinical trial to assess the safety and dosimetry profiles of 177Lu-DOTA-EB-TATE in patients with advanced, metastatic or inoperable, somatostatin receptor-positive, well-differentiated GEP-NETs.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More 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.

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 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05475210
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Molecular Targeting Technologies, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Lisa Bodei, MD, PhD
Principal Investigator Affiliation Memorial Sloan Kettering Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Neuroendocrine Tumors
Arms & Interventions

Arms

Experimental: Peptide Receptor Radionucleotide Therapy (PRRT)

The treatment regimen will consist of a single-dose intravenous administration of 177Lu-DOTA-EB-TATE per 6-week cycle, for a total of 2 cycles. The dose per cycle will be fixed for each patient and will be escalated in 3 different dose levels, from 50 mCi to 150 mCi (1.85 -5.55 GBq). Each dose of 177Lu-DOTA-EB-TATE will be administered in association with intravenous renal protective amino acid solutions.

Interventions

Drug: - 177Lu-DOTA-EB-TATE

Peptide Receptor Radionucleotide Therapy ( PRRT) using 177Lu-DOTA-EB-TATE with a defined number of cycles will be administered.

Other: - Amino Acid Solution

The Amino acid solution to be used in this study will contain a mixture of lysine and arginine diluted in an electrolyte solution.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Site Contact

Lisa Bodei, MD, PhD

cpak@mtarget.com

610-738-7938

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