RecruitingPhase 2ACTRN12620000849998

A clinical trial to assess the safety, tolerability and efficacy of MG010 in combination with sorafenib-(Nexavar), in people with solid tumours who have failed existing treatments.

A phase I/II, open label, multi-centre study to assess the safety, tolerability, and efficacy of MG010 in combination with sorafenib in subjects with solid tumours who have failed existing treatments.


Sponsor

Metagone Biotech Australia Pty Ltd

Enrollment

50 participants

Start Date

May 12, 2020

Study Type

Interventional

Conditions

Summary

This purpose of this study is to determine the safety, tolerability and efficacy of MG010 in combination with sorafenib in patients with solid tumors who have failed existing treatments Who is it for? You may be eligible to join this study if you are aged between 18 years and above, and have histologically confirmed diagnosis of advanced or metastatic solid tumors for which standard treatment is unavailable/ineffective/intolerable Study details All participants in this study will receive MG010 and sorafenib. This study will have 2 stages: the dose escalation stage and the dose expansion stage. In the dose escalation stage, there will be 3 groups of participants who each receive different doses of each drug. The drug will be given orally once every day of a 28-day cycle. In the dose expansion stage, participants will receive once/twice a day MG010 and once daily sorafenib (at a dose determined from the dose escalation stage) for up to 6 28-day cycles. Participants will be monitored for reactions and treatment effectiveness, and provide blood and urine for analysis. Medical imaging, e.g. PET and/or CAT scans for stage I will be performed at the beginning and the end. For stage II 5 images will be taken throughout the study; at screening, days, 56, 112, 168 and 210. It is hoped this trial will provide information on the treatment of solid tumours by demonstrating a benefit in the proposed combination treatment, by improving the tolerability and expand the usage of sorafenib in cancer treatment.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental drug called MG010 in combination with sorafenib — an established cancer medication — in people with advanced solid tumours (cancers that form solid masses, as opposed to blood cancers) who have not responded to standard treatments. The study aims to find the right dose of MG010, assess safety, and get early signals of whether the combination might be effective. The trial is conducted in two stages. The first stage gradually increases the dose of MG010 (dose escalation) to find the safest and most effective level. The second stage tests that dose in patients with specific cancer types: non-small cell lung cancer, renal cell carcinoma, colorectal cancer, or hepatocellular carcinoma (liver cancer). Both drugs are taken orally once or twice daily in 28-day cycles, and participants will have regular blood tests and scans. You may be eligible if you are 18 or older, have a confirmed advanced or metastatic solid tumour for which standard treatments have not worked or are no longer available, have reasonably good physical functioning (ECOG 0-2), and have adequate organ function. Women must not be pregnant or breastfeeding, and all participants must use reliable contraception throughout the study.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Stage 1 of the trial - dose escalation Cohort 1: 200mg tablet Sorafenib once daily and 200 mg capsule MG010 once daily for up to one cycle (28 days) Cohort 2: 200mg tablet Sorafenib once daily and 4

Stage 1 of the trial - dose escalation Cohort 1: 200mg tablet Sorafenib once daily and 200 mg capsule MG010 once daily for up to one cycle (28 days) Cohort 2: 200mg tablet Sorafenib once daily and 400 mg capsules MG010 once daily for one cycle (28 days) Cohort -1: 200mg tablet Sorafenib once daily and 100 mg capsule MG010 once daily for one cycle (28 days) Cohort and Phase Timing: Cohort 1 concludes when all subjects complete their cycles, then safety assessments are undertaken within 7 days of the last patients. If Dose Limiting Toxicity (DLT) is observed in >1 out of 6 subjects in cohort 1, 3 subjects will be recruited for dose cohort -1 (dose de-escalation); Cohort 2 commences with 3 new patients and after all subjects complete their cycles, then within 7 days safety assessments are performed. After approximately 2 weeks, if all goes well, the report of the safety committee will be finalised, after which stage 2 will commence if the report provides a favourable recommendation. Stage 1 participants are eligible for stage 2, subject to signing a new informed consent and compliance with the inclusion exclusion criteria. Stage 2 of the trial - dose expansion stage The dose will be decided at the completion of stage 1. Sorafenib once daily and MG010 once or twice daily for up to six cycles (168 days) Adherence will be monitored by returned medication counts.


Locations(4)

The Chris O’Brien Lifehouse - Camperdown

NSW,QLD, Australia

Scientia Clinical Research - Randwick

NSW,QLD, Australia

Concord Repatriation Hospital - Concord

NSW,QLD, Australia

Icon Cancer Care South Brisbane - South Brisbane

NSW,QLD, Australia

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ACTRN12620000849998