A Study Investigating the Efficacy and Safety of Ociperlimab and Tislelizumab and BAT1706 Combinations in Patients With Advanced HCC

Advanced Hepatocellular Carcinoma Clinical Trial

Official title:

A Phase 2, Randomized, Open-labeled Clinical Study Investigating the Efficacy and Safety of Ociperlimab in Combination With Tislelizumab Plus BAT1706 and of Tislelizumab Plus BAT1706 as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04948697
• Other study ID #: AdvanTIG-206
• Secondary ID: CTR20211546
• Status: Completed
• Phase: Phase 2
• Start date: August 20, 2021
• Est. completion date: February 1, 2024

Study information

• Verified date: February 2024
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 2, randomized, multicenter, open-label, 2-arm study to investigate the efficacy and safety of ociperlimab in combination with tislelizumab plus BAT1706, and tislelizumab plus BAT1706, as first-line treatment in participants with advanced HCC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Criteria:

Inclusion Criteria:

1. Histologically confirmed HCC

2. BCLC Stage C disease, or BCLC Stage B disease that is not amenable to or has progressed after loco-regional therapy, and is not amenable to a curative treatment approach

3. Tumor tissue required for an evaluable PD-L1 expression result

4. No prior systemic therapy for HCC

5. At least 1 measurable lesion as defined per RECIST v1.1

6. Adequate organ function during screening and before randomization

Exclusion Criteria:

1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology

2. Prior therapy with antibody or drug specifically targeting T-cell costimulation or checkpoint pathway; prior treatment with bevacizumab or its biosimilars

3. Prior history of = Grade 2 hepatic encephalopathy

4. Leptomeningeal disease or uncontrolled, untreated brain metastasis

5. Active autoimmune diseases or history of autoimmune diseases that may relapse

6. History of interstitial lung disease, non-infectious pneumonitis or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases

7. Infection (including tuberculosis) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days of randomization

8. Prior allogeneic stem cell transplantation or organ transplantation

9. Significant cardiovascular risk factors

10. Untreated or incompletely treated esophageal or gastric varices with bleeding or high risk of bleeding

11. History of severe hypersensitivity reactions to other monoclonal antibodies

12. Administered a live vaccine = 28 days before randomization

NOTE: Other protocol Inclusion/Exclusion criteria may apply

Related Conditions & MeSH terms

• Advanced Hepatocellular Carcinoma
• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• Ociperlimab
900 mg intravenously once every 3 weeks (dosed in 21-day cycles)
• Tislelizumab
200 mg intravenously once every 3 weeks (dosed in 21-day cycles)
• BAT1706
15 mg/kg intravenously once every 3 weeks (dosed in 21-day cycles)

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing
China	Hunan Cancer Hospital	Changsha	Hunan
China	West China Hospital Sichuan University	Chengdu	Sichuan
China	Chongqing University Three Gorges Hospital	Chongqing	Chongqing
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Nanfang Hospital of Southern Medical University	Guangdong
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Mengchao Hepatobiliary Hospital of Fujian Medical University	Gulou	Fuzhou
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	The Second Affiliated Hospital of Nanchang University	Jiangxi
China	Fudan University Zhongshan Hospital	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	Tianjin Medical University Cancer institute & Hospital	Tianjin	Tianjin
China	Tianjin Third Central Hospital	Tianjin	Tianjin
China	Hubei Cancer Hospital	Wuhan	Hubei
China	Hwa Mei Hospital, University of Chinese Academy of Sciences	Zhejiang
Taiwan	Chi Mei Medical Center	Tainan
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Chang Gung Medical Foundation (CGMF) - Linkou Branch	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Countries where clinical trial is conducted

China,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR) as assessed by the investigator	defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v1.1	Time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary	Duration of Response (DOR) as assessed by the investigator	DOR is the time from the date of first documentation of a partial response (PR) or better to the date of first documentation of progressive disease (PR or better). DOR will be assessed based on RECIST v1.1.	time from the first confirmed objective response until the first documentation of disease progression or death, whichever comes first. assessed up to 24 months
Secondary	TIme to Response (TTR) as assessed by the investigator	TTR is defined as the time from the date of first dose administration to the date of first documented partial response (PR) or better by the investigator. TTR will be assessed based on RECIST v1.1.	time from the date of first dose of study drug to the first documentation of response, assessed up to 24 months
Secondary	Disease Control Rate (DCR) as assessed by the investigator	DCR is defined as the percentage of participants who achieve complete response (CR), partial response (PR) or durable stable disease (stable disease defined as greater than or equal to (=) 24 weeks)). The DCR will be assessed based on RECIST v1.1.	time from the first confirmed objective response until the first documentation of disease progression or death, whichever comes first, assessed up to 24 months
Secondary	Clinical Benefit Rate (CBR)	defined as the proportion of participants who achieve complete response (CR), partial response (PR), or durable stable disease (stable disease defined as greater than or equal to (=) 24 weeks)	time from the first confirmed objective response until the first documentation of disease progression or death, whichever comes first, assessed up to 24 months
Secondary	PFS as assessed by the investigator	PFS will be evaluated by the investigator according to RECIST version 1.1. PFS is defined as the time from the date of first dose to the date of first documentation of disease progression or date of death from any cause, whichever occurs first	time from the date of the first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first, assessed up to 24 months
Secondary	Overall Survival (OS)	measured time from the date of the first dose of study drug until the date of death from any cause	time from the date of the first dose of study drug until the date of death from any cause, assessed up to 24 months
Secondary	Incidence and severity of adverse events (AEs),	severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version [v] 5.0, vital signs and clinical laboratory test results	time from the date of the first dose of study drug until the date of death from any cause, assessed up to 24 months
Secondary	Serum concentrations of ociperlimab at specified timepoints	Collected at time intervals: predose on Day 1 of Cycles 1, 2, 5, 9 and 17. Postdose on Day 1 of Cycles 1 and 5 and Safety Follow-up Visit	Through study completion, up to 24 months
Secondary	Serum concentrations of tislelizumab at specified timepoints	Collected at time intervals: predose on Day 1 of Cycles 1, 2, 5, 9 and 17. Postdose on Day 1 of Cycles 1 and 5 and Safety Follow-up Visit	Through study completion, up to 24 months
Secondary	Serum concentrations of BAT1706 at specified timepoints	Collected at time intervals: predose on Day 1 of Cycles 1,2, 5, 9, and 17. Postdose on Day 1of Cycles 1 and 5 and EOT Visit	Through study completion, up to 24 months
Secondary	Immunogenic Response to ociperlimab	evaluated through detection of antidrug antibodies (ADAs). Time to onset of immunogenic response will be reported Collected at time intervals: predose on Day 1 of Cycles 1, 2, 5, 9 and 17, and at Safety Follow-up Visit	Through study completion, up to 24 months
Secondary	Immunogenic Response to tislelizumab	evaluated through detection of antidrug antibodies (ADAs). Time to onset of immunogenic response will be reported Collected at time intervals: predose on Day 1 of Cycles 1, 2, 5, 9 and 17, and at Safety Follow-up Visit	Through study completion, up to 24 months
Secondary	Immunogenic Response to BAT1706	evaluated through detection of antidrug antibodies (ADAs). Time to onset of immunogenic response will be reported Collected at time intervals: predose on Day 1 of Cycles 1, 2, 5, 9 and 17, and at EOT Visit	Through study completion, up to 24 months