A Study of the Combination of Anti-PD-1 AK105 and Anlotinib in First-line Hepatocellular Carcinoma (HCC)

NCT04172571 | Completed Phase 2 FDA Drug

• 1 other identifier: AK105-203
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center,open-label study to evaluate the efficacy and safety of anti-PD-1 antibody AK105 plus anlotinib hydrochloride in the first-line treatment of patients with unresectable hepatocellular carcinoma.

Conditions

Hepatocellular Carcinoma

Keywords

VEGF; Anti-PD-1; Tyrosine Kinase Inhibitor (TKI); Angiogenesis-related kinases

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  ORR is the proportion of subjects with CR or PR based on RECIST v1.1.

  up to approximately 18 months

Secondary Outcomes (7)

• Number of subjects experiencing adverse events (AEs)

  From the time of informed consent through 90 days after last dose of AK105

• Duration of response (DoR)

  up to approximately 18 months

• Disease control rate (DCR)

  up to approximately 18 months

• Progression-free survival (PFS)

  up to approximately 18 months

• Overall survival (OS)

  up to approximately 24 months

Study Arms (1)

AK105 and anlotinib

EXPERIMENTAL

Biological: AK105; Drug: Anlotinib Hydrochloride

Interventions

AK105 BIOLOGICAL

Anti-PD-1 antibody; IV infusion, 200 mg Q3W

AK105 and anlotinib

Anlotinib Hydrochloride DRUG

multi-targeted receptor TKI; oral administration; every 3 weeks as one cycle administered as 2 weeks on/1 week off

AK105 and anlotinib

Eligibility Criteria

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

You may qualify if:

• Signed written informed consent form voluntarily.
• Male or female，age over 18 years old (inclusive) and not more than 75 years old (inclusive), when signing the ICF.
• Expected life expectance ≥ 3 months.
• Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
• Confirmation either by histology unresectable hepatocellular carcinoma..
• BCLC stage C, and non-resectable BCLC stage B .
• No prior systemic therapy for HCC.
• Child-Pugh class A and B (≤7 points).
• At least one measurable lesion according to RECIST criteria.
• Adequate hematologic and end-organ function.
• For women of childbearing potential: agreement to remain abstinent; For men: agreement to remain abstinent.

You may not qualify if:

• Prior treatment with anti-PD1, anti-PD-L1 or anti-CTLA-4 antibody therapy.
• Active ongoing infection requiring therapy.
• History of severe hypersensitivity reaction to another monoclonal antibody.
• Received any live attenuated vaccine within the last 30 days.
• Other malignancy requiring treatment in the prior 5 years with the exception of locally treated squamous or basal cell carcinoma.
• Pregnant, breast feeding, or planning to become pregnant.
• Active or prior documented autoimmune or inflammatory disease with some exceptions.
• Central nervous system metastases and/or carcinomatous meningitis.
• Medical condition that requires chronic systemic steroid therapy, or any other form of immunosuppressive medication.
• Co-infection of HBV and HCV.
• Inadequately controlled arterial hypertension.

Sponsors & Collaborators

• Akeso: lead
• Akeso Tiancheng, Inc: collaborator

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (2)

• Huang Z, Pang X, Zhong T, Qu T, Chen N, Ma S, He X, Xia D, Wang M, Xia M, Li B. Penpulimab, an Fc-Engineered IgG1 Anti-PD-1 Antibody, With Improved Efficacy and Low Incidence of Immune-Related Adverse Events. Front Immunol. 2022 Jun 27;13:924542. doi: 10.3389/fimmu.2022.924542. eCollection 2022.

  PMID: 35833116 DERIVED

• Han C, Ye S, Hu C, Shen L, Qin Q, Bai Y, Yang S, Bai C, Zang A, Jiao S, Bai L. Clinical Activity and Safety of Penpulimab (Anti-PD-1) With Anlotinib as First-Line Therapy for Unresectable Hepatocellular Carcinoma: An Open-Label, Multicenter, Phase Ib/II Trial (AK105-203). Front Oncol. 2021 Jul 13;11:684867. doi: 10.3389/fonc.2021.684867. eCollection 2021.

  PMID: 34327136 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Shunchang Jiao, MD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

• Li Bai, MD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 21, 2019
• Study Start: November 22, 2018
• Primary Completion: June 1, 2022
• Study Completion: July 8, 2022
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)