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

NCT05444088 | Recruiting Phase 1

• 1 other identifier: SHR-8068-II-201-HCC
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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]

Study Arms (3)

Adebrelimab in combination with Bevacizumab

EXPERIMENTAL

Drug: Adebrelimab; Drug: Bevacizumab

Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D1

EXPERIMENTAL

Drug: Adebrelimab; Drug: Bevacizumab; Drug: SHR-8068

Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D2

EXPERIMENTAL

Drug: Adebrelimab; Drug: Bevacizumab; Drug: SHR-8068

Interventions

Adebrelimab DRUG

intravenous infusion

Adebrelimab in combination with Bevacizumab; Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D1; Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D2

Bevacizumab DRUG

intravenous infusion

Adebrelimab in combination with Bevacizumab; Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D1; Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D2

SHR-8068 DRUG

intravenous infusion

Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D1; Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Anhui Provincial Hospital Ethics Commitee

Hefei, Anhui, 230000, China

RECRUITING

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Xin Shi

CONTACT

0518-82342973; xin.shi.xs3@hengrui.com

Ying Sun

CONTACT

0518-82342973; ying.sun.ys1@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is a multicenter, open-label, dose-finding and efficacy-expansion phase Ib/II study. The phase Ib design is for dose finding and dose confirmation, using modified 3+3 design; the phase II design is for efficacy expansion through randomization.

Study Record Dates

• First Submitted: June 26, 2022
• First Posted: July 5, 2022
• Study Start: August 2, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

CN (1)