MEDI-573 in Combination With SOC in Unresectable or Metastatic HCC. (MEDI-573-1028)

MedImmune

Status and phase: Completed; Phase 1

Conditions: Unresectable or Metastatic Hepatocellular Carcinoma (HCC)

Treatments: Drug: MEDI-573 (1 of 3 doses); Drug: Sorafenib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01498952

CD-ON-MEDI-573-1028

Details and patient eligibility

About

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).

Enrollment: 6 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 5 patient groups

Phase 1b Cohort A

Experimental group

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.

Treatment:

Drug: MEDI-573 (1 of 3 doses)

Drug: Sorafenib

Phase 1b Cohort B

Experimental group

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.

Treatment:

Drug: MEDI-573 (1 of 3 doses)

Drug: Sorafenib

Phase 1b Cohort C

Experimental group

Description:

Participants will receive MEDI-573 30 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.

Treatment:

Drug: MEDI-573 (1 of 3 doses)

Drug: Sorafenib

Phase 2 Arm 1

Experimental group

Description:

Participants will receive recommended dose of MEDI-573 from Phase 1b IV 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.

Treatment:

Drug: MEDI-573 (1 of 3 doses)

Drug: Sorafenib

Phase 2 Arm 2

Active Comparator group

Description:

Participants will receive sorafenib 400 mg orally twice daily until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons.

Treatment:

Drug: Sorafenib