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

NCT ID: NCT03591965

Last Updated: 2023-07-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-07
• Study Completion Date: 2022-08-03

Brief Summary

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ATG-008

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.

Group Type: EXPERIMENTAL

ATG-008

Intervention Type: DRUG

Approximately 20 subjects will receive oral ATG-008 at an initial dose of 45 mg/QD and another 20 subjects will receive oral ATG-008 at an initial dose of 20mg/BID for 28 days each cycle.

Interventions

ATG-008

Approximately 20 subjects will receive oral ATG-008 at an initial dose of 45 mg/QD and another 20 subjects will receive oral ATG-008 at an initial dose of 20mg/BID for 28 days each cycle.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Antengene Therapeutics Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Xie, PhD

Role: STUDY_DIRECTOR

Medical Monitor

Locations

Oncology Hospital of Haerbin Medical University

Harbin, Heilongjiang, China

China People PLA 81 Hospital

Nanjing, Jiangsu, China

West China Hospital Sichuan University

Chengdu, Sichuan, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

The first Hospital of Jilin University

Changchun, , China

Hunan Province Oncology Hospital

Changsha, , China

Daping Hospital

Chongqing, , China

The first hospital of Chongqing medical university

Chongqing, , China

Xiehe Hospital of Fujian Medical University

Fuzhou, , China

Nanfang Hospital of Nanfang Medical University

Guangzhou, , China

The first affiliated Hospital of Zhejiang University

Hangzhou, , China

Zhejiang Province Oncology Hospital

Hangzhou, , China

The first affiliated hospital of Anhui medical university

Hefei, , China

The second affiliated hospital of Anhui medical university

Hefei, , China

The first affiliated hospital of Guangxi Medical University

Nanning, , China

Oncology Hospital of Fudan University

Shanghai, , China

Zhongshan Hospital of Fudan University

Shanghai, , China

General Hospital of the Northern War Zone of the Chinese People's Liberation Army

Shenyang, , China

Tangdu Hospital of China PLA fourth medical university

Xi'an, , China

Dong-A University Hospital

Busan, , South Korea

Pusan National Univ. Hospital

Busan, , South Korea

Kyungpook National Univ. Hospital

Daegu, , South Korea

Asan Medical Center

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

China Medical University Hospital

Taichung, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Taipei Medical University Hospital

Taipei, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Chang Gung Memorial Hospital-Linkuo

Taoyuan District, , Taiwan

Countries

China; South Korea; Taiwan

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ATG-008-HCC-001

Identifier Type: -

Identifier Source: org_study_id