A Study of MT-303 in Adults With Advanced or Metastatic GPC3-Expressing Cancers, Including HCC

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

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.

Conditions4

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