A PHASE I STUDY OF CODRITUZUMAB, IN COMBINATION WITH ATEZOLIZUMAB IN PATIENTS WITH HEPATOCELLULAR CARCINOMA

A PHASE I, OPEN-LABEL, MULTI-CENTER, DOSE-ESCALATION STUDY OF CODRITUZUMAB, AN ANTI-GLYPICAN-3 MONOCLONAL ANTIBODY, IN COMBINATION WITH ATEZOLIZUMAB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC HEPATOCELLULAR CARCINOMA

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223270

Enrollment

Registered

2016-07-22

Start date

2016-08-29

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

locally advanced or metastatic hepatocellular carcinoma

Interventions

investigational material(s) Generic name etc : Codrituzumab INN of investigational material : codrituzumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Histologically confirmed hepatocellular carcinoma with Glypican-3 staining on tumor by immunohistochemistry >= 2. - Prior treatment with at least 1 systemic agent. - Male or female >= 18 years old. - Eastern Cooperative Oncology Group Performance Status of 0-1. - Child-Pugh score 5-7.

Exclusion criteria

Exclusion criteria: - History of autoimmune disease. - Prior treatment with anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents.

Design outcomes

Primary

Measure	Time frame
safety Endpoints:MTD Method:NCI CTCAE	—

Secondary

Measure	Time frame
safety efficacy pharmacokinetics Endpoints:Safety, anti-tumor activity, PK Method:NCI CTCAE, RECIST	—

Countries

Japan, Taiwan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026