Clinical trial · Interventional
MEDI-573 in Combination With SOC in Unresectable or Metastatic HCC.
A Phase 1b/2, Open-label, Randomized Study of MEDI-573 in Combination With Sorafenib Verses Sorafenib Alone in Adult Subjects With Unresectable or Metastatic Hepatocellular Carcinoma
NCT01498952CI-TRIAL-00037155MEDI-573-1028completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A Phase 1b/2, open-label, randomized study to evaluate MEDI-573 in combination with standard of care in adult subjects with unresectable or metastatic hepatocellular carcinoma (HCC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unresectable or Metastatic Hepatocellular Carcinoma (HCC) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MEDI-573 (1 of 3 doses) | Drug | — | UNRESOLVED |
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Phase 1b Cohort A
- description
- Participants will receive MEDI-573 10 mg/kg intravenous infusion on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons.
- interventionNames
- Drug: MEDI-573 (1 of 3 doses)
- Drug: Sorafenib
- type
- EXPERIMENTAL
- label
- Phase 1b Cohort B
- description
- Participants will receive MEDI-573 45 mg/kg intravenous infusion on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons.
- interventionNames
- Drug: MEDI-573 (1 of 3 doses)
- Drug: Sorafenib
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years or minimum age of consent per local regulations at the time of screening * Unresectable or metastatic hepatocellular carcinoma * ECOG Performance Status ≤ 2 * Life expectancy of ≥ 3 months; Exclusion Criteria: * Child-Pugh Score for Cirrhosis Mortality \> 7 points * Prior or current system anti-cancer therapy for HCC, including cytotoxic, biologic, targeted or experimental therapy * Prior local treatment for HCC less than 4 weeks prior to initiating study treatment * Active second malignancy * Major surgery, open biopsy or significant traumatic injury within 4 weeks prior to initiating study treatment * Thrombotic or embolic events within 6 months prior to initiating study treatment * Ongoing pancreatitis * Uncontrolled or refractory ascites * Evidence of ongoing spinal cord compression, known carcinomatous meningitis, or known leptomeningeal carcinomatosis * Hepatic encephalopathy \> Grade 1 * Active brain metastases with exceptions * Poorly controlled diabetes mellitus * Active coronary artery disease * Uncontrolled hypertension
References
Publications (0)
Data not yet available
No reference posted for this study.