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

Primary Purpose

Advanced Hepatocellular Carcinoma

Status

Not yet recruiting

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Adebrelimab

Bevacizumab

SHR-8068

About this trial

This is an interventional treatment trial for Advanced Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Adebrelimab in combination with Bevacizumab

Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D1

Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D2

Arm Description

Outcomes

Primary Outcome Measures

Dose Limiting Toxicity

Incidence and severity of grade ≥3 drug-related adverse events and serious adverse events of the two-drug or three-drug combination

Objective Response Rate

determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points

Secondary Outcome Measures

Disease Control Rate, determined using RECIST v1.1 criteria

Progression-Free-Survival assessed by investigator

Full Information

NCT ID

NCT05444088

First Posted

June 26, 2022

Last Updated

June 30, 2022

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05444088

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

August 1, 2022 (Anticipated)

Primary Completion Date

June 30, 2026 (Anticipated)

Study Completion Date

June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Hepatocellular Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

129 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Adebrelimab in combination with Bevacizumab

Arm Type

Experimental

Arm Title

Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D1

Arm Type

Experimental

Arm Title

Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D2

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Adebrelimab

Intervention Description

intravenous infusion

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Intervention Description

intravenous infusion

Intervention Type

Drug

Intervention Name(s)

SHR-8068

Intervention Description

intravenous infusion

Primary Outcome Measure Information:

Title

Dose Limiting Toxicity

Time Frame

The observation period is 21 days after the first dose

Title

Incidence and severity of grade ≥3 drug-related adverse events and serious adverse events of the two-drug or three-drug combination

Time Frame

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

Title

Objective Response Rate

Description

determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points

Time Frame

At the time point of every 6 or 9 weeks, up to 2 years

Secondary Outcome Measure Information:

Title

Disease Control Rate, determined using RECIST v1.1 criteria

Time Frame

At the time point of every 6 or 9 weeks, up to 2 years

Title

Progression-Free-Survival assessed by investigator

Time Frame

up to 2 years]

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xin Shi

Phone

0518-82342973

xin.shi.xs3@hengrui.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ying Sun

Phone

0518-82342973

ying.sun.ys1@hengrui.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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