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

Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05444088
Collaborator
(none)
129
Enrollment
3
Arms
46.9
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
129 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2026
Anticipated Study Completion Date :
Jun 30, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Dose Limiting Toxicity [The observation period is 21 days after the first dose]

  2. 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]

  3. Objective Response Rate [At the time point of every 6 or 9 weeks, up to 2 years]

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

Secondary Outcome Measures

  1. Disease Control Rate, determined using RECIST v1.1 criteria [At the time point of every 6 or 9 weeks, up to 2 years]

  2. Progression-Free-Survival assessed by investigator [up to 2 years]]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05444088
Other Study ID Numbers:
  • SHR-8068-II-201-HCC
First Posted:
Jul 5, 2022
Last Update Posted:
Jul 5, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Bevacizumab

Study Results

No Results Posted as of Jul 5, 2022