Study of SHR-8068 Combined With Adebrelimab and Bevacizumab in the Treatment of Advanced Hepatocellular Carcinoma

An Open-label, Multicenter Phase Ib/II Clinical Study of SHR-8068 Combined With Adebrelimab and Bevacizumab in the Treatment of Advanced Hepatocellular Carcinoma

To evaluate the tolerability and safety of SHR-8068 in combination with Adebrelimab and Bevacizumab in subjects with advanced HCC; To evaluate the efficacy of SHR-8068 in combination with Adebrelimab and Bevacizumab in subjects with advanced HCC.

Study Overview

• Status: Recruiting
• Conditions: Advanced Hepatocellular Carcinoma
• Intervention / Treatment: Drug: Adebrelimab; Drug: Bevacizumab; Drug: SHR-8068

• Study Type: Interventional
• Enrollment (Estimated): 129
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Xin Shi; Phone Number: 0518-82342973; Email: xin.shi.xs3@hengrui.com
• Study Contact Backup: Name: Ying Sun; Phone Number: 0518-82342973; Email: ying.sun.ys1@hengrui.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • Recruiting
      • Anhui Provincial Hospital Ethics Commitee
      • Contact: Lianxin Liu, Doctor; Phone Number: +86-13845159888; Email: liulx@ustc.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18~75 years old, both male and female;
2. Stage 1: pathologically diagnosed, incurable advanced HCC subjects who have failed standard treatment or were unwilling to accept standard treatment;
3. Stage 2: pathologically diagnosed, incurable advanced HCC subjects, who have no prior immunotherapy, no more than 1 line of previous system treatment;
4. At least one measurable lesion based on RECIST v1.1 criteria;
5. Barcelona clinic liver cancer: Stage B or C;
6. ECOG PS score: 0-1 points;
7. Child-Pugh score: ≤ 7;
8. Expected survival period ≥ 3 months;
9. Adequate organ function.

Exclusion Criteria:

1. Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma or mixed cholangiocarcinoma / hepatocellular carcinoma;
2. Patients with any active, known or suspected autoimmune disorder;
3. Systemic treatment with corticosteroids or other immunosuppressants within 1 month before the first dose;
4. With known severe allergic reactions to any other monoclonal antibodies;
5. Patients with known CNS metastasis or hepatic encephalopathy;
6. Patients with liver tumor burden greater than 50% of total liver in volume, or patients who have previously undergone liver transplantation;
7. Patients with symptomatic ascites or pleural effusion requiring paracentesis and drainage, or patients who have undergone ascites or pleural effusion drainage within 2 weeks before the first dose;
8. Patients with other malignancies currently or within the past 5 years;
9. Patients with hypertension which cannot be well controlled by antihypertensives;
10. Uncontrolled cardiac diseases or symptoms;
11. Patients with other potential factors that may affect the study results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adebrelimab in combination with Bevacizumab	Drug: Adebrelimab; intravenous infusion; Drug: Bevacizumab; intravenous infusion
Experimental: Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D1	Drug: Adebrelimab; intravenous infusion; Drug: Bevacizumab; intravenous infusion; Drug: SHR-8068; intravenous infusion
Experimental: Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D2	Drug: Adebrelimab; intravenous infusion; Drug: Bevacizumab; intravenous infusion; Drug: SHR-8068; intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose Limiting Toxicity		The observation period is 21 days after the first dose
Incidence and severity of grade ≥3 drug-related adverse events and serious adverse events of the two-drug or three-drug combination		The observation period is from the time when all informed subjects signed the informed consent to the end of the safety follow-up period, up to 2 years
Objective Response Rate	determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points	At the time point of every 6 or 9 weeks, up to 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Disease Control Rate, determined using RECIST v1.1 criteria	At the time point of every 6 or 9 weeks, up to 2 years
Progression-Free-Survival assessed by investigator	up to 2 years]

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: June 26, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 20, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: SHR-8068-II-201-HCC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No