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

Suzhou Suncadia Biopharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Advanced Hepatocellular Carcinoma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05444088

SHR-8068-II-201-HCC

Details and patient eligibility

About

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.

Enrollment: 129 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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129 participants in 3 patient groups

Adebrelimab in combination with Bevacizumab

Experimental group

Treatment:

Drug: Bevacizumab

Drug: Adebrelimab

Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D1

Experimental group

Treatment:

Drug: Bevacizumab

Drug: SHR-8068

Drug: Adebrelimab

Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D2

Experimental group

Treatment:

Drug: Bevacizumab

Drug: SHR-8068

Drug: Adebrelimab