Neoplasms

All Conditions

Rare Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Somatostatin

Participants will receive 7.4GBq (200mCi) Lutetium\[177Lu\] Oxodotreotide Injection every 8 weeks.

Lutetium[177Lu] Oxodotreotide Injection

Shan Zhang

Jie Chen, MD

This is a multicenter, single-arm, two-part study designed to evaluate the safety and efficacy of Lutetium \[177Lu\] Oxyoctreotide Injection in patients with inoperable, locally advanced or metastatic, progressive, advanced somatostatin receptor (SSTR) positive neuroendocrine neoplasms (NEN) other than grade G1/G2 gastroenteropancreatic neuroendocrine tumors (GEP-NET).

This study consists of two parts, the exploratory study (Part 1) and the pivotal study (Part 2).

In both parts, participants who signs Informed consent form (ICF) and is eligible for the study will be enrolled. Participants will receive 7.4GBq (200mCi) Lutetium \[177Lu\] Oxyoctreotide every 8 weeks. The objective tumor response will be assessed every 12 weeks from the time of the first dose according to RECIST 1.1 until disease progression.

A Clinical Study to Evaluate the Safety and Efficacy of Lutetium[177Lu] Oxodotreotide Injection in Patients With Advanced Neuroendocrine Neoplasms

A Clinical Study to Evaluate the Safety and Efficacy of Lutetium[177Lu] Oxodotreotide Injection in Patients With Advanced Somatostatin Receptor Positive Neuroendocrine Neoplasms

Sinotau Pharmaceutical Group

Symptoms and General Pathology

Substance Related Disorders

Syndrome

Carcinoid Tumor

Malignant Carcinoid Syndrome

Serotonin Syndrome

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Carcinoid Syndrome

Antineoplastic Agents

Mitoguazone

Patients receive retifanlimab IV over 30-60 minutes on day 1 and telotristat ethyl PO TID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Retifanlimab

Telotristat Ethyl

Daniel M Halperin, MD

This phase II trial studies the effect of retifanlimab and telotristat ethyl in treating patients with neuroendocrine tumors that have spread to other places in the body (advanced) and carcinoid syndrome. Retifanlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Telotristat ethyl is a drug used to reduce side effects of carcinoid syndrome. Giving retifanlimab and telotristat ethyl may help to control neuroendocrine tumors in patients who also have carcinoid syndrome.

PRIMARY OBJECTIVE:

I. To evaluate the efficacy of retifanlimab (A12) + telotristat ethyl (TE).

SECONDARY OBJECTIVE:

I. To evaluate the efficacy of A12 + TE.

SAFETY OBJECTIVES:

I. To evaluate the safety of A12 + TE. II. To evaluate the safety of withholding concurrent somatostatin analogue in patients receiving A12 + TE.

EXPLORATORY BIOMARKER OBJECTIVE:

I. To identify biomarkers that are predictive of response to A12 + TE (i.e., predictive biomarkers), are associated with progression to a more severe disease state (i.e., prognostic biomarkers), are associated with resistance to A12 + TE, are associated with susceptibility to developing adverse events, can provide evidence of study treatment activity, or can increase the knowledge and understanding of disease biology.

OUTLINE:

Patients receive retifanlimab intravenously (IV) over 30-60 minutes on day 1 and telotristat ethyl orally (PO) 3 times daily (TID) on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years.

Retifanlimab (INCMGA00012) and Telotristat Ethyl for the Treatment of Advanced Neuroendocrine Tumors and Carcinoid Syndrome

A Phase II, Open-Label, Single-Arm Study of INCMGA00012 and Telotristat Ethyl in Patients With Advanced Neuroendocrine Tumors and Carcinoid Syndrome

Will estimate the best response rate and its 95% exact confidence interval using the Clopper and Pearson method.

Will be determined by an independent radiologist according to immune-modified RECIST.

Will be determined by an independent radiologist according to RECIST v1.1. Will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model may be utilized to include multiple covariates in the time-to-event analysis.

Will be determined by an independent radiologist according to RECIST v1.1.

Will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model may be utilized to include multiple covariates in the time-to-event analysis.

Will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. Toxicity data will be summarized by frequency tables.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Clinical Study to Evaluate the Safety and Efficacy of Lutetium[177Lu] Oxodotreotide Injection in Patients With Advanced Neuroendocrine Neoplasms	NCT06398444	Advanced Neuroe...	Lutetium[177Lu]...	18 Years -	Sinotau Pharmaceutical Group
A Clinical Study to Evaluate the Safety and Efficacy of Lutetium[177Lu] Oxodotreotide Injection in Patients With Advanced Neuroendocrine Neoplasms	NCT06398444	Advanced Neuroe...	Lutetium[177Lu]...	18 Years -	Sinotau Pharmaceutical Group
Retifanlimab (INCMGA00012) and Telotristat Ethyl for the Treatment of Advanced Neuroendocrine Tumors and Carcinoid Syndrome	NCT04776876	Advanced Neuroe... Carcinoid Syndr...	Retifanlimab Telotristat Eth...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for advanced neuroendocrine neoplasm