Dual TORC1/TORC2 Inhibitor ATG-008 (CC-223) in HBV Positive Advanced Hepatocellular Carcinoma (HCC) Subjects

Antengene

Status and phase: Terminated; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: ATG-008

Study type: Interventional

Funder types: Industry

Identifiers

NCT03591965

ATG-008-HCC-001

Details and patient eligibility

About

This is an Asian multi-regional clinical trial (MRCT) in which ATG-008 will be administered orally to hepatitis B positive (HBV+) HCC subjects who have received at least one prior line of systemic therapy. It is designed as an open-label phase 2 trial evaluating the pharmacokinetics (PK), safety, tolerability and efficacy of oral ATG-008 administered daily until the radiologic disease progression (according to RECIST 1.1) or intolerable toxicity.

Enrollment: 73 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female aged from 18 to 70 years (inclusive) at the time when the ICF is signed.
2. Confirmed diagnosis of HCC.
3. Unresectable stage B or C HCC according to the Barcelona Clinic Liver Cancer (BCLC) staging.
4. HBV positive by serum test.
5. Received at least one prior line of systemic therapy.
6. ECOG performance status score of 0 or 1.
7. Satisfactory serum chemistry results
8. Adequate bone marrow function
9. Child-Pugh A without encephalopathy.
10. All subjects who participated in the study had to take reliable contraceptive measures within the trial and 3 months of after the trial.

Exclusion criteria

1. Symptomatic central nervous system metastases.
2. Locoregional HCC therapy, systemic chemotherapy, hormonal therapy or investigational therapy within 4 weeks prior to Screening.
3. Life expectancy of less than 3 months.
4. Prior therapy with mTOR inhibitors.
5. Prior organ transplant.
6. Persistent diarrhea or malabsorption.
7. Clinically significant bleeding.
8. Known history of human immunodeficiency virus (HIV) infection.
9. Uncontrolled intercurrent illness.
10. Any condition that confounds the ability to interpret data from the trial.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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73 participants in 1 patient group

ATG-008

Experimental group

Description:

To enroll approximately 40 hepatitis B virus (HBV) positive, unresectable HCC subjects who have previously received at least one prior line of systemic therapy. Among which, approximately 20 subjects will receive oral ATG-008 at an initial dose of 45 mg, once daily (QD) and another approximately 20 subjects will receive oral ATG-008 at an initial dose of 20 mg, twice daily (BID). The pharmacokinetic (PK) samples will be collected from 10 subjects each in the two dose groups.

Treatment:

Drug: ATG-008