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

NCT05475210 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: MTTI-EBT-00121-362
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (3)

• To evaluate the safety of 177Lu-DOTA-EB-TATE assessed from the number of patients with treatment-related adverse events.

  16-17 months

• To identify the dose-limiting toxicities (DLTs) of escalating doses of 177Lu-DOTA-EB-TATE up to 150 mCi.

  16-17 months

• To determine if the maximum tolerated dose is among the explored doses of 50, 100 and 150 mCi.

  16-17 months

Secondary Outcomes (2)

• To evaluate the differential safety of 177Lu-DOTA-EB-TATE, expressed as the number of patients with treatment-related adverse events following 177Lu-DOTA-EB-TATE.

  16-17 months

• To evaluate dosimetry levels in patients following 2 cycles of 177Lu-DOTA-EB-TATE.

  16-17 months

Study Arms (1)

Peptide Receptor Radionucleotide Therapy (PRRT)

EXPERIMENTAL

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.

Drug: 177Lu-DOTA-EB-TATE; Other: Amino Acid Solution

Interventions

177Lu-DOTA-EB-TATE DRUG

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

Peptide Receptor Radionucleotide Therapy (PRRT)

Amino Acid Solution OTHER

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

Also known as: Arginine-Lysine Solution

Peptide Receptor Radionucleotide Therapy (PRRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Molecular Targeting Technologies, Inc.: lead
• ClinSmart: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

(177)Lu-DOTA-EB-TATE; amino-acid, glucose, and electrolyte solution

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Lisa Bodei, MD, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chris Pak

CONTACT

610-738-7938; cpak@mtarget.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: July 26, 2022
• Study Start: June 18, 2022
• Primary Completion: December 31, 2024
• Study Completion: March 30, 2025
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)