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Study of CVM-1118 for Patients With Advanced Neuroendocrine Tumors | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Study of CVM-1118 for Patients With Advanced Neuroendocrine Tumors

A Phase II, Open-label Study of CVM-1118 Administered Orally to Patients With Advanced Neuroendocrine Tumors

NCT03600233•TaiRx, Inc.

Summary

CVM-1118 (TRX-818) is a new small molecule chemical entity being developed as a potential anti-cancer therapeutic by TaiRx, Inc. CVM-1118 is a potent anti-cancer agent in numerous human cancer cell lines. The safety of administrating CVM-1118 on human is evaluated from the phase 1 study. The objectives of the phase 2 study is to further investigate the efficacy of CVM-1118 for patients with advanced neuroendocrine tumors.

Detailed Description

Neuroendocrine tumors (NETs) are a group of uncommon heterogeneous malignancies originating from neuroendocrine cells localized throughout the body. Approximately 50% of patients with NETs would have metastatic cancer, where 65% of patients with metastatic cancer would result in mortality within 5 years of diagnosis. The current treatments of NETs do not follow single discipline and the effective agents are largely still under clinical investigations. Apparent formation of vasculogenic mimicry (VM) has been reported in at least two types of NETs. Moreover, VM has been found as part of multiple microvascular alterations in mouse models of pancreatic neuroendocrine tumors. Wih the high potential of inhibiting VM formation, CVM-1118 is considered to have therapeutic potentials in treating NET tumors.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients eligible for inclusion in this study must meet ALL of the following criteria:
•1. \[Tumor eligibility\] Histologically or cytologically confirmed advanced (unresectable and/or metastatic) neuroendocrine tumors that are well-differentiated, low or intermediate grade (WHO Grade 1 or 2) of pancreatic or gastrointestinal, or low/ intermediate grade of lung origin, that are refractory to standard of care therapy, or for whom no standard of care therapy is available.
•2. Patients must have measurable or evaluable disease as per RECIST criteria v1.1. Target lesions that have been previously irradiated will not be considered measurable (lesion) unless increase in size is observed following completion of radiation therapy.
•3. Patients must have documented progressive disease within 6 months prior enrollment after prior therapy.
•4. Patients who are on therapy with a somatostatin analog are eligible but progressive disease must be demonstrated subsequent to establishment for at least 3 months of a stable dose.
•5. Male or female, 20 years of age or older.
•6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
•7. Resolution of all acute toxic effects of prior therapy or surgical procedures to Grade 1 (except alopecia).
•8. Adequate organ function as defined by the following criteria:
•* Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≦ 3 x upper limit of normal (ULN), or AST and ALT ≦ 5 x ULN if liver function abnormalities are due to underlying malignancy
+7 more criteria

Exclusion Criteria

•Patients eligible for this study must not meet ANY of the following criteria:
•1. Poorly differentiated neuroendocrine carcinoma, or high grade neuroendocrine tumor.
•2. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
•3. Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of starting study treatment.
•4. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.
•5. Current treatment on another clinical trial.
•6. Patients who are using other investigational agents or who had received investigational drugs within 4 weeks prior to study enrollment.
•7. Brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease unless appropriately treated and neurologically stable for at least 4 weeks.
•8. Any of the following within the 12 months prior to starting study treatment:
•myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack; within 6 months prior to starting study treatment for pulmonary embolus. However, upon agreement between the investigator and sponsor, the 6-month post-event-free period for a patient with a pulmonary embolus can be waived if due to advanced cancer. Appropriate treatment with anticoagulants is permitted.
+7 more criteria

Locations (8)

Chang Gung Memorial Hospital, KaoHsiung

Kaohsiung City, Taiwan

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

New Taipei Municipal TuCheng Hospital

New Taipei City, Taiwan

China Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Chang Gung Memorial Hospital, LinKou

Taoyuan, Taiwan

Key Dates

Start Date

December 15, 2018

Primary Completion Date

September 30, 2024

Completion Date

March 31, 2026

Last Updated

December 23, 2025

Enrollment

ACTUAL participants

Conditions

Neuroendocrine TumorsPancreatic Neuroendocrine TumorGastro-enteropancreatic Neuroendocrine TumorLung Neuroendocrine NeoplasmNeuroendocrine Carcinoma

Interventions

CVM-1118

DRUG

Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors

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Neuroendocrine TumorsWell-Differentiated Neuroendocrine Carcinoma+1 more

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RECRUITINGPHASE2

Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER)

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Small Cell Carcinoma of the BladderHigh Grade Neuroendocrine Tumors of the Urinary Tract

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of CVM-1118 for Patients With Advanced Neuroendocrine Tumors

Inclusion Criteria

Exclusion Criteria

Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors

Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER)

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F-Tryptophan PET/CT in Human Cancers

Pancreatic Neuroendocrine Tumour - Optimal Surgical Debulking or Not