NCT06478693 A Study of MT-303 in Adults With Advanced or Metastatic GPC3-Expressing Cancers, Including HCC
| NCT ID | NCT06478693 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Myeloid Therapeutics |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 70 participants in total. It began in 2024-07-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a multicenter, open-label, Phase 1, first-in-human, dose-escalation study designed to assess the safety, tolerability and define the RP2D of MT-303 alone (Module 1) and in combination with Atezo/Bev (Module 2) in participants with advanced hepatocellular carcinoma expressing GPC3.
Eligibility Criteria
Inclusion Criteria * Aged 18 years or older * Histological diagnosis of advanced/recurrent or metastatic and/or unresectable HCC. \[Note: participants with other tumor types expressing GPC3 may be eligible for Module 1 pending a discussion with the Medical Monitor. Only participants with HCC are eligible for Module 2. * Measurable lesion per RECIST 1.1 criteria * Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 * Child-Pugh score: Class A * Adequate organ function General Exclusion Criteria * Known active CNS metastasis and/or carcinomatous meningitis. * Any acute illness including active infection * History of liver transplantation or on waiting list * Participants with untreated or incompletely treated varices with bleeding or high risk for bleeding * Uncontrolled pleural effusion, pericardial effusion, or ascites * History of symptomatic congestive heart failure * History of chronic or recurrent (within the last year) severe autoimmune or immune mediated disease requiring steroids or other immune-suppressive treatments. Additional Module 2 Exclusion Criteria: * Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC. * Significant cardiovascular disease * History of severe hypersensitivity to atezolizumab and/or bevacizumab. * History of idiopathic pulmonary fibrosis * Prior history of hypertensive crisis or hypertensive encephalopathy.
Contact & Investigator
Matthew Maurer, MD
STUDY DIRECTOR
Myeloid Therapeutics
Frequently Asked Questions
Who can join the NCT06478693 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06478693 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06478693 currently recruiting?
Yes, NCT06478693 is actively recruiting participants. Contact the research team at Lucy.FrereScott@novotech-cro.com for enrollment information.
Where is the NCT06478693 trial being conducted?
This trial is being conducted at Sydney, Australia, Woolloongabba, Australia, Melbourne, Australia, Murdoch, Australia and 5 additional locations.
Who is sponsoring the NCT06478693 clinical trial?
NCT06478693 is sponsored by Myeloid Therapeutics. The principal investigator is Matthew Maurer, MD at Myeloid Therapeutics. The trial plans to enroll 70 participants.
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