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Neuroendocrine TumorsPhase 2NCT03600233

Study of CVM-1118 for Patients With Advanced Neuroendocrine Tumors

A Phase 2 study testing CVM-1118 in people with Neuroendocrine Tumors and Pancreatic Neuroendocrine Tumor, run by TaiRx, Inc. at 8 sites in Taiwan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
CVM-1118
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
8 sitesTaiwan
Study dates
15 Dec 2018to 31 Mar 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients eligible for inclusion in this study must meet ALL of the following criteria:
  • [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.
  • 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.
  • Patients must have documented progressive disease within 6 months prior enrollment after prior therapy.
  • 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.
  • Male or female, 20 years of age or older.
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  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
  • Resolution of all acute toxic effects of prior therapy or surgical procedures to Grade 1 (except alopecia).
  • 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
  • Total serum bilirubin ≦ 1.5 x ULN (except for patients with documented Gilbert's syndrome)
  • Absolute neutrophil count (ANC) ≧ 1500/µL
  • Platelets ≧ 90,000/µL
  • Hemoglobin ≧ 9.0 g/dL
  • Serum creatinine ≦ 2.0 x ULN or creatinine clearance of ≧ 50 mL/min
  • Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Who cannot join

  • Patients eligible for this study must not meet ANY of the following criteria:
  • Poorly differentiated neuroendocrine carcinoma, or high grade neuroendocrine tumor.
  • Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
  • Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of starting study treatment.
  • Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.
  • Current treatment on another clinical trial.
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  • Patients who are using other investigational agents or who had received investigational drugs within 4 weeks prior to study enrollment.
  • Brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease unless appropriately treated and neurologically stable for at least 4 weeks.
  • 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.
  • Hypertension that cannot be controlled by medications (> 160/100 mmHg despite optimal medical therapy).
  • Current treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
  • Known history of human immunodeficiency virus (HIV) seropositivity and/or is receiving anti-retroviral therapy.
  • Hepatitis B virus (HBV) or hepatitis C virus (HCV) with evidence of chronic active disease or receiving/requiring antiviral therapy.
  • History of receiving organ transplantation or immune disorders that require continuous immunosuppressant agent therapy.
  • Pregnancy or breastfeeding. Female patients must be surgically sterile or be postmenopausal or must agree to the use of effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the Investigator or a designated associate.
  • Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that would impart, in the judgment of the investigator and/or Sponsor, excess risk associated with study participation or study drug administration, which would make the patient inappropriate for entry into this study.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Taiwan8 sites

  • Chang Gung Memorial Hospital, KaoHsiung

    Kaohsiung City

  • Kaohsiung Medical University Hospital

    Kaohsiung City

  • New Taipei Municipal TuCheng Hospital

    New Taipei City

  • China Medical University Hospital

    Taichung

  • Taichung Veterans General Hospital

    Taichung

  • National Cheng Kung University Hospital

    Tainan, 704

  • Taipei Veterans General Hospital

    Taipei

  • Chang Gung Memorial Hospital, LinKou

    Taoyuan City

Other trials in Taiwan

About this study

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

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.

Read the 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.

Being tested
CVM-1118
Keywords
Oncology, Neuroendocrine Tumors, NET, Vasculogenic mimicry
Medical subject headings
Neuroendocrine Tumors, Adenoma, Islet Cell, Gastro-enteropancreatic neuroendocrine tumor, Carcinoma, Neuroendocrine, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CVM-1118Drug

    Also called TRX-818

    Patients will initially receive CVM-1118 orally twice daily at 200 mg per dose (400 mg total daily dose).

    Patients who tolerate this dose for at least 2 Cycles will have the option of increasing the dose of CVM-1118 to 300 mg BID (600 mg total daily dose) if specific criteria are met.

Study groups in NCT03600233
Study groupRoleWhat they receive
CVM-1118ExperimentalCVM-1118 200mg or 300mg Bis In Die (BID) daily/ Cycle (28 days per cycle)
Receives: Drug: CVM-1118

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time-to progression-free survival (PFS)

    Measure the Time-to PFS or death to any cause. The tumor assessment will be performed every 12 weeks until documented disease progression, death, or date of follow-up.

    Measured: 12 months after the last patient enrolled

Secondary outcomes (20)

  1. Objective response rate (ORR)

    ORR is defined as the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR), based on the investigator's assessment as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria v1.1.

    Measured: up to 12 months after the last patient enrolled

  2. Disease control rate (DCR)

    DCR is defined as the proportion of patients with a best overall response of CR, PR, or Stable Disease (SD), based on the investigator's assessment per RECIST criteria v1.1.

    Measured: up to 12 months after the last patient enrolled

  3. Duration of overall response (DoR)

    DoR is measured only for the responder subset: patients with confirmed CR or PR based on the investigator's assessment. It is the elapsed time between the date of first documented response and the following date of event defined as the first documented disease progression or death due to underlying cancer, per RECIST criteria v1.1.

    Measured: up to 12 months after the last patient enrolled

  4. Time-to progression (TTP)

    TTP is defined as the duration of time from initiation of study medication to first documentation of tumor progression.

    Measured: up to 12 months after the last patient enrolled

  5. Time-to overall survival (OS)

    OS is defined as the duration of time from initiation of study medication to death due to any cause.

    Measured: up to 12 months after the last patient enrolled

  6. Number of participants with treatment-related adverse events (AEs) as assessed by CTCAE v4.03

    Assessment of adverse events will based on the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE].

    Measured: During the course of the trial or within 28 days following termination from the trial

  7. Number of Participants With Abnormal baseline and out-of range Hematology Count by CTCAE v4.03

    Values with CTCAE v4.03 Grade ≧ 3 will be identified with flags. A final outcome result with the number of participants with abnormal laboratory values would be provided. A list of all laboratory normal ranges will also be provided.

    Measured: From baseline of screening up to end of treatment or withdraw, an average of 12 months

  8. Number of Participants With Abnormal Laboratory Values_Assessed the baseline and out-of range urinalysis test by CTCAE v4.03

    Values with CTCAE v4.03 Grade ≧ 3 will be identified with flags. A final outcome result with the number of participants with abnormal laboratory values would be provided. A list of all laboratory normal ranges will also be provided.

    Measured: From baseline of screening up to end of treatment or withdraw, an average of 12 months

  9. Number of Participants With Abnormal Laboratory Values_Assessed the baseline and out-of range coagulation test by CTCAE v4.03

    Normal range of PT/PTT will be provided. Values with CTCAE v4.03 Grade ≧ 3 will be identified with flags. A final outcome result with the number of participants with abnormal laboratory values would be provided.

    Measured: From baseline of screening up to end of treatment or withdraw, an average of 12 months

  10. Number of Participants With Abnormal Vital Sign_Assessed the baseline and out-of-range vital signs_ body temperature by CTCAE v4.03

    Values with CTCAE v4.03 Grade ≧ 3 will be identified with flags. A final outcome result with the number of participants with abnormal vital sign would be provided. Normal ranges will also be provided.

    Measured: From baseline of screening up to end of treatment or withdraw, an average of 12 months

  11. Number of Participants With Abnormal Vital Sign_Assessed the baseline and out-of-range vital signs_ blood pressure by CTCAE v4.03

    Values with CTCAE v4.03 Grade ≧ 3 will be identified with flags. A final outcome result with the number of participants with abnormal vital sign would be provided. Normal ranges will also be provided.

    Measured: From baseline of screening up to end of treatment or withdraw, an average of 12 months

  12. Number of Participants With Abnormal Vital Sign_Assessed the baseline and out-of-range vital signs_ heart rate by CTCAE v4.03

    Values with CTCAE v4.03 Grade ≧ 3 will be identified with flags. A final outcome result with the number of participants with abnormal vital sign would be provided. Normal ranges will also be provided.

    Measured: From baseline of screening up to end of treatment or withdraw, an average of 12 months

  13. Number of Participants With Abnormal Vital Sign_Assessed the baseline and out-of-range vital signs_ respiratory rate by CTCAE v4.03

    Values with CTCAE v4.03 Grade ≧ 3 will be identified with flags. A final outcome result with the number of participants with abnormal vital sign would be provided. Normal ranges will also be provided.

    Measured: From baseline of screening up to end of treatment or withdraw, an average of 12 months

  14. Abnormalities in electrocardiography (ECG)

    a 12-lead (with a 10-second rhythm strip) tracing, with a capacity to calculate the standard intervals automatically, will be used.

    Measured: From baseline of screening up to end of treatment or withdraw, an average of 12 months

  15. Maximum Plasma Concentration [Cmax] of CVM-1118 and its metabolite CVM-1125 after CVM-1118 dosing

    PK parameters will be calculated for CVM-1118 and its metabolite CVM-1125 during this study.

    Measured: Cycle 1 and Cycle 2 (each cycle is 28 days)

  16. Area Under the Curve [AUC] of CVM-1118 and its metabolite CVM-1125 after CVM-1118 dosing

    PK parameters will be calculated for CVM-1118 and its metabolite CVM-1125 during this study.

    Measured: Cycle 1 and Cycle 2 (each cycle is 28 days)

  17. Pharmacodynamics analysis for the relationship of Cmax and PFS

    The correlations of PK parameter, Cmax and key efficacy endpoint will be evaluated in this study.

    Measured: Cycle 1 and Cycle 2 (each cycle is 28 days)

  18. Pharmacodynamics analysis for the relationship of AUC and PFS

    The correlations of PK parameter, AUC and key efficacy endpoint will be evaluated in this study.

    Measured: Cycle 1 and Cycle 2 (each cycle is 28 days)

  19. Pharmacodynamics analysis for the relationship of AUC and AE

    The correlations of PK parameter, AUC and key safety endpoint will be evaluated in this study.

    Measured: Cycle 1 and Cycle 2 (each cycle is 28 days)

  20. Pharmacodynamics analysis for the relationship of Cmax and AE

    The correlations of PK parameter, Cmax and key safety endpoint will be evaluated in this study.

    Measured: Cycle 1 and Cycle 2 (each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2018
  2. Study start15 Dec 2018
  3. Primary completion30 Sep 2024
  4. Study completion31 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03600233
Sponsor's protocol ID
CVM-005
Status last verified
Dec 2025
First submitted
7 Jun 2018
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Yen CJ, Chen MH, Chen YY, Bai LY, Chen JS, Hsieh JC, Shih YH, Wu IC, Chen YL, Chen CM, Chao TY, Chu YW, Chien DS. Efficacy and safety of a novel oral anti-vasculogenic mimicry agent, CVM-1118, in advanced well-differentiated neuroendocrine tumors: a Phase IIa trial. Br J Cancer. 2026 Jul 2. doi: 10.1038/s41416-026-03515-w. Online ahead of print.

    PubMed 42393461

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CVM-1118 in people with Neuroendocrine Tumors and Pancreatic Neuroendocrine Tumor, run by TaiRx, Inc. at 8 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time-to progression-free survival (PFS) (time frame: 12 months after the last patient enrolled). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03600233, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.

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