Solid TumorPhase 1NCT03406364

Assess the Safety and Activity of Combined MG005 and Sorafenib (NEXAVAR®) Treatment With Solid Tumor

A Phase 1 study testing MG005 in people with Solid Tumor, run by Metagone Biotech Inc. at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The proposed initial trial is a Phase I, open label study to evaluate the safety and explore efficacy of MG005 in combination with sorafenib in patients with solid tumor. The eligible patients will receive 200 mg of sorafenib with 3 pre-defined dose levels of GW5074, escalated from 750 mg to 1500 mg (daily dose), to… Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Solid Tumor
What is being tested?: MG005
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteTaiwan
Study dates: 6 Jun 2018to 24 Jul 2020
Phase: Phase 1
Are there results?: None posted in the registry

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

Patient who is able to understand the nature of this study and accepts to enter the study by signing written informed consent
Patients who are ≥ 20 years of age
Patients with histologically confirmed advanced or metastatic disease that is either refractory to or intolerant of existing standard therapy or for which no effective standard therapy that confers clinical benefit is available (patients may have received prior therapy with sorafenib if not intolerable)
Patient has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Patient able to provide either an archived tumor sample or with accessible tumor for biopsy and willingness to provide it prior to initiation of study treatment
At least 4 weeks post any therapeutic modalities (e.g., surgery, radiotherapy, and therapeutic agents) prior to initial dosing except the palliative radiotherapy performed on non-study-related local lesions

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Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2 8.Patient's life expectancy of at least 3 months
9.Patient has adequate hematopoietic, hepatic function and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
Hemoglobin ≥ 9.0 g/dL
Absolute neutrophil count (ANC) ≥ 1,500 cells/μL
Total white blood cell (WBC) ≥ 3,000 cells/μL
Platelet ≥ 100,000 counts/μL
Total bilirubin ≤ 1.5× upper limit of normal (ULN) and no sign of jaundice
ALT and AST ≤ 2.5× ULN (≤ 5× ULN for patients with liver involvement)
ALP ≤ 5× ULN
Creatinine ≤ 1.5× ULN
Potassium, total calcium and magnesium within normal limits or correctable with supplements 10.Patient is able to take food and drug orally. 11.Patient is able to correctly operate the provided digital sphygmomanometer. 12.Female patient with childbearing potential should be confirmed of not being pregnant or not lactating at the screening and during the study.
13.Patient is willing to comply with protocol-stated requirements, instructions and restrictions.

Who cannot join

Patient who has participated in other investigational studies and received any investigational therapy within 4 weeks prior to study dosing
Patient carries history of primary malignancy other than the entry diagnosis except curatively treated non-melanoma skin cancer, cervical carcinoma in situ, or superficial bladder tumors within 5 years prior to study entry.
Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of GW5074 and sorafenib (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
Patient with known leptomeningeal or brain metastasis (including those who require glucocorticoids or intrathecal chemotherapy) by radiologic/histological evidence, or only bone metastasis
Patient with history of significant cardiac disease including superior vena cava, unstable angina, congestive heart failure > class 2 per New York Heart Association (NYHA) classification, cardiac arrhythmias, cardiac ischemia/infarction, long QT-syndrome (i.e., QTc > 450 msec for males and > 470 msec for females), poorly controlled hypertension (systolic blood pressure > 150 mm-Hg and/or diastolic blood pressure > 90 mm-Hg on anti-hypersensitive medications), and valvular heart disease
History of organ or bone marrow transplant

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Patient who has not recovered from side/toxic effects of previous therapy (i.e., NCI-CTCAE grade 1 or less) prior to the first dose of study medications
Patients who are receiving or with conditions requiring substances that are potent inducers of CYP3A4 activity (e.g., rifampin, St. John's wort, phenytoin, carbamazepine, phenobarbital, and dexamethasone)
Patients who are receiving or with conditions requiring sensitive substrates of CYP1A2, 1B1, 2C8, 2C19 and 3A4 with narrow therapeutic windows (e.g., theophylline, duloxetine, alosetron, tizanidine, repaglinide, omeprazole, S-mephenytoin, alfentanil, sirolimus, pimozide, and tacrolimus)
History of stroke or transient ischemic attack within 6 months of study entry
Patient with any hemorrhage/bleeding event (e.g., non-healing wound, ulcer, and bone fracture) ≥ NCI-CTCAE grade 2 within 28 days prior to study treatment, or history of bleeding diathesis or coagulopathy
Patients with poorly controlled ascites and/or requirement for therapeutic paracentesis more frequently than once every 3 months
Patients with HIV, acute HBV, and HCV (except hepatitis carriers) infections
Patient with known or suspected hypersensitivity to any agent given in the course of this trial
Patient with underlying medical, mental or psychological conditions that would impair the treatment compliance, or in the opinion of the investigator would not permit to participate in the study
Male and female patients (with child-bearing potential [between puberty and 2 years after menopause]) who are unwilling to practice an effective method of birth control (safe hormonal methods or/and barrier contraception) during the entire study period and 2 months after the last study drug intake

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Tri-Service General Hospital
Taipei, Nehu District, 114

Other trials in Taiwan

About this study

Official title: A Phase I Study to Assess the Safety and Activity of Combined MG005 and Sorafenib (NEXAVAR®) Treatment in Patients With Solid Tumor

Conditions: Solid Tumor
Being tested: MG005

What participants receive

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

MG005Drug
Phase I:
Eligible patients will receive different dosages of GW5074 in 1 of the 3 dose cohorts plus 200 mg of sorafenib. Dose cohorts will be escalated sequentially from Cohort 1 at 750 mg QD GW5074 plus 200 mg QD sorafenib to Cohort 2 at 1500 mg QD GW5074 plus 200 mg QD sorafenib, and Cohort 3 at 750 mg BID GW5074 plus 200 mg QD sorafenib. Owing to the fact that there is no previous human experience for GW5074, Cohort 1 will include a monotherapy stage with 750 mg QD GW5074 prior to administration of the GW5074 and sorafenib combination to initially assess the safety of GW5074 monotherapy.

Study groups in NCT03406364
Study group	Role	What they receive
MG005	Experimental	Cohort 1 :3 × 250 mgMG005+1 × 200 mgSorafenib[8:00 AM (±2 hours)] Cohort 2 :6 × 250 mgMG005+1 × 200 mgSorafenib[8:00 AM (±2 hours)] Cohort 3 :3 × 250 mgMG005+1 × 200 mgSorafenib; 3 × 250 mgMG005+1 × 200 mgSorafenib[8:00 AM (±2 hours); 8:00 PM (±2 hours)] Receives: Drug: MG005

What is being measured

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

Maximum Tolerated Dose(MTD)and Dose Limiting(DLT) -phase I
MTD by defining DLTs for MG005 and in combination with sorafenib.
Measured: DLTs will be assessed during the initial 8-week treatment periods for Cohort 1.
Maximum Tolerated Dose(MTD)and Dose Limiting(DLT) -phase I
MTD by defining DLTs for MG005 and in combination with sorafenib.
Measured: DLTs will be assessed during the initial 4-week treatment periods for Cohort 2/3

Timeline

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

6 Jun 201824 Jul 2020

First posted23 Jan 2018
Study start6 Jun 2018
Primary completion9 Jan 2020
Study completion24 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid TumorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Model description: Phase I: Eligible subjects will receive 1 of 3 different dosages of the combination therapy of GW5074 and sorafenib. The dose cohorts include: * Monotherapy with 750 mg QD GW5074, followed by 750 mg QD GW5074 + 200 mg QD Sorafenib * 1500 mg QD GW5074 + 200 mg QD Sorafenib * 750 mg BID GW5074 + 200 mg QD Sorafenib
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03406364
Sponsor's protocol ID: MEOMG1A20170313
Status last verified: Apr 2021
First submitted: 8 Jan 2018
Last updated: 26 Apr 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Study to Assess the Safety and Activity of Combined MG005 and Sorafenib (NEXAVAR®) Treatment in Patients With Solid Tumor
ClinicalTrials.gov ID: NCT03406364
Acronym / sponsor ID: MEOMG1A20170313
Conditions: Solid Tumor
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Metagone Biotech Inc.Industry (pharma, biotech, devices)
Study start: 6 Jun 2018 (actual)
Primary completion: 9 Jan 2020 (actual)
Study completion: 24 Jul 2020 (actual)
First posted: 23 Jan 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1
Model description: Phase I: Eligible subjects will receive 1 of 3 different dosages of the combination therapy of GW5074 and sorafenib. The dose cohorts include: * Monotherapy with 750 mg QD GW5074, followed by 750 mg QD GW5074 + 200 mg QD Sorafenib * 1500 mg QD GW5074 + 200 mg QD Sorafenib * 750 mg BID GW5074 + 200 mg QD Sorafenib

Arm	Type	Receives
MG005	Experimental	Drug: MG005Cohort 1 :3 × 250 mgMG005+1 × 200 mgSorafenib[8:00 AM (±2 hours)] Cohort 2 :6 × 250 mgMG005+1 × 200 mgSorafenib[8:00 AM (±2 hours)] Cohort 3 :3 × 250 mgMG005+1 × 200 mgSorafenib; 3 × 250 mgMG005+1 × 200 mgSorafenib[8:00 AM (±2 hours); 8:00 PM (±2 hours)]

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

Patient who is able to understand the nature of this study and accepts to enter the study by signing written informed consent
Patients who are ≥ 20 years of age
Patients with histologically confirmed advanced or metastatic disease that is either refractory to or intolerant of existing standard therapy or for which no effective standard therapy that confers clinical benefit is available (patients may have received prior therapy with sorafenib if not intolerable)
Patient has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Patient able to provide either an archived tumor sample or with accessible tumor for biopsy and willingness to provide it prior to initiation of study treatment

Key exclusion criteria (16 listed)

Patient who has participated in other investigational studies and received any investigational therapy within 4 weeks prior to study dosing
Patient carries history of primary malignancy other than the entry diagnosis except curatively treated non-melanoma skin cancer, cervical carcinoma in situ, or superficial bladder tumors within 5 years prior to study entry.
Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of GW5074 and sorafenib (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
Patient with known leptomeningeal or brain metastasis (including those who require glucocorticoids or intrathecal chemotherapy) by radiologic/histological evidence, or only bone metastasis
Patient with history of significant cardiac disease including superior vena cava, unstable angina, congestive heart failure > class 2 per New York Heart Association (NYHA) classification, cardiac arrhythmias, cardiac ischemia/infarction, long QT-syndrome (i.e., QTc > 450 msec for males and > 470 msec for females), poorly controlled hypertension (systolic blood pressure > 150 mm-Hg and/or diastolic blood pressure > 90 mm-Hg on anti-hypersensitive medications), and valvular heart disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MG005Phase I: Eligible patients will receive different dosages of GW5074 in 1 of the 3 dose cohorts plus 200 mg of sorafenib. Dose cohorts will be escalated sequentially from Cohort 1 at 750 mg QD GW5074 plus 200 mg QD sorafenib to Cohort 2 at 1500 mg QD GW5074 plus 200 mg QD sorafenib, and Cohort 3 at 750 mg BID GW5074 plus 200 mg QD sorafenib. Owing to the fact that there is no previous human experience for GW5074, Cohort 1 will include a monotherapy stage with 750 mg QD GW5074 prior to administration of the GW5074 and sorafenib combination to initially assess the safety of GW5074 monotherapy.	Drug	MG005

Primary outcome

Maximum Tolerated Dose(MTD)and Dose Limiting(DLT) -phase I
Time frame: DLTs will be assessed during the initial 8-week treatment periods for Cohort 1.
MTD by defining DLTs for MG005 and in combination with sorafenib.
Maximum Tolerated Dose(MTD)and Dose Limiting(DLT) -phase I
Time frame: DLTs will be assessed during the initial 4-week treatment periods for Cohort 2/3
MTD by defining DLTs for MG005 and in combination with sorafenib.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.

Related trials for Solid Tumor

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MG005 in people with Solid Tumor, run by Metagone Biotech Inc. at 1 site 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 18 inclusion and 16 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: finished, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maximum Tolerated Dose(MTD)and Dose Limiting(DLT) -phase I (time frame: DLTs will be assessed during the initial 8-week treatment periods for Cohort 1.). The study lists 2 primary outcomes in all. 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 NCT03406364.

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 26 Apr 2021.