Clinical trial · Interventional
Evaluation of 177Lu-TATE-EB-01(LNC1010)in SSTR2-positive Tumors
A Phase 1/2, Non-Randomized, Open-Label, Dose Escalation, Single-Center Study to Determine the Safety, Bio-distribution, and Preliminary Effectiveness and Efficacy of 177Lu-TATE-EB-01(LNC1010)in Adult Subjects With SSTR2-positive Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
177Lu-LNC1010(177Lu-EB-TATE-01) is a radiotherapeutic drug indicated in subjects with unresectable, metastatic somatostatin receptor (SSTR) positive tumors. In this study, we designed and developed a new radioligand, EB-TATE-01 (second generation long-acting EB-TATE formula), through combining EB and altering the linker to further improve the pharmacokinetics and pharmacodynamics, leading to substantially enhanced radioligand therapy effect. This is an open-label, non-controlled, non-randomized study to investigate the long-lasting radiolabeled somatostatin analogue based peptide receptor radionuclide therapy and evaluate response to 177Lu-LNC1010 in patients with advanced SSTR2-positive tumors. Different groups with doses of 2.22GBq (60 mCi), 3.33GBq (90mCi) and 4.99GBq (145mCi) of 177Lu-LNC1010 will be injected intravenously. All patients will undergo 68Ga-DOTA-Octreotide(TATE) PET/CT scans before and after the treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| SSTR2-positive Tumors | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 177Lu-LNC1010 1 | Drug | — | UNRESOLVED |
| 177Lu-LNC1010 2 | Drug | — | UNRESOLVED |
| 177Lu-LNC1010 3 | Drug | — | UNRESOLVED |
| 177Lu-LNC1010 4 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- 177Lu-LNC1010 1
- description
- The patients were intravenously injected with single dose 2.22GBq (60 mCi) of 177Lu-LNC1010 and underwent 68Ga-DOTA-TATE PET/CT scans before and after the treatment.
- interventionNames
- Drug: 177Lu-LNC1010 1
- type
- EXPERIMENTAL
- label
- 177Lu-LNC1010 2
- description
- The patients were intravenously injected with single dose 3.33GBq (90 mCi) of 177Lu-LNC1010 and underwent 68Ga-DOTA-TATE PET/CT scans before and after the treatment.
- interventionNames
- Drug: 177Lu-LNC1010 2
- type
- EXPERIMENTAL
- label
- 177Lu-LNC1010 3
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 18 years or older; * Histologically proven or cytologically confirmed SSTR positive cancers; * Measurable disease as defined by Response Criteria in Solid Tumors (RECIST) version 1.1; * Overexpression of somatostatin receptors of the target lesions at 68Ga-DOTA-TATE positron emission tomography (PET)/computed tomography (CT) with standard uptake value(SUV) of lesions greater than normal liver in at least 1 lesion; * Patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee. Exclusion Criteria: * Women who are pregnant or breastfeeding; * History of allergic reactions attributed to compounds of similar chemical or biologic composition to 177Lu-EB-TATE as assessed from medical records; * Previous radioligand 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 \< 3 months as assessed by the treating physician; * 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; * The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
References
Publications (1)
- RESULTZhu W, Cheng Y, Jia R, Zhao H, Bai C, Xu J, Yao S, Huo L. A Prospective, Randomized, Double-Blind Study to Evaluate the Safety, Biodistribution, and Dosimetry of 68Ga-NODAGA-LM3 and 68Ga-DOTA-LM3 in Patients with Well-Differentiated Neuroendocrine Tumors. J Nucl Med. 2021 Oct;62(10):1398-1405. doi: 10.2967/jnumed.120.253096. Epub 2021 Feb 12. PMID 33579804