MT-303 +Atezolizumab + Bevacizumab: MT-303 in combination with Atezo/Bev
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Type, incidence and severity of Adverse Events — Up to 2 years from the last dose of Investigational Medicinal Product (IMP) Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v5.0
Recommended Phase 2 Dose (RP2D) — 28 days from the last dose of IMP The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data
Optimal Biological dose (OBD) — 21 days from the last dose of IMP The OBD will be determined using dose limiting toxicities (DLTs) and all other available study data
Change from baseline in vital signs — Up to 30 days from the last dose of IMP Temperature, weight, height, pulse rate and blood pressure will be assessed
Change in laboratory parameters — Up to 30 days from the last dose of IMP Hematology, chemistry, coagulation, virology and urine analysis will be assessed.
Change from baseline in ECG parameters — Screening, Day 1 and Day 15
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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