A Phase 1 interventional study of MG005 in Solid Tumor, sponsored by Metagone Biotech Inc.. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-04-26.
Sponsored by Metagone Biotech Inc. · Phase 1, Interventional, and Treatment
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 determine the Maximum Tolerated Dose (MTD) and dose limiting toxicities (DLT) (if any) at Phase I stage.
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:
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.
Exclusion Criteria:
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\[8:00 AM (±2 hours); 8:00 PM (±2 hours)\]
Drug: MG005
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.
Maximum Tolerated Dose(MTD)and Dose Limiting(DLT) -phase I
MTD by defining DLTs for MG005 and in combination with sorafenib.
Time frame: 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.
Time frame: DLTs will be assessed during the initial 4-week treatment periods for Cohort 2/3
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Metagone Biotech Inc.