A Study Evaluating the Efficacy and Safety of ZG005 in Combination With Donafenib or Bevacizumab in Patients With Advanced Hepatocellular Carcinoma

NCT06233994 | Unknown

• 1 other identifier: ZG005-IIT-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, open-label study to evaluate the safety and efficacy of ZG005 in combination with Donafenib or Bevacizumab in patients with advanced hepatocellular carcinoma.

Conditions

Advanced Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR)

  The sum of the proportions of subjects who achieved CR or PR in imaging evaluation as assessed by the investigator based on RECIST1.1 criteria.

  up to approximately 2 years

• Progression Free Survival (PFS)

  Time from first dose of the investigational drug to PD or death from any cause.

  up to approximately 2 years

Study Arms (2)

ZG005+Donafenib

EXPERIMENTAL

Participants will receive ZG005 plus Donafenib until unacceptable toxicity or loss of clinical benefit.

Biological: ZG005 Powder for Injection; Drug: Donafenib Tosilate Tablets

ZG005+Bevacizumab

EXPERIMENTAL

Participants will receive ZG005 plus bevacizumab until unacceptable toxicity or loss of clinical benefit.

Biological: ZG005 Powder for Injection; Biological: Bevacizumab

Interventions

ZG005 Powder for Injection BIOLOGICAL

ZG005 will be administered at a dose of 10 mg/kg by intravenous (IV) infusion, once every 3 weeks (Q3W).

Also known as: ZG005

ZG005+Bevacizumab; ZG005+Donafenib

Donafenib Tosilate Tablets DRUG

Donafenib will be administered at a dose of 0.2 g by orally, Bis in die(Bid).

Also known as: Donafenib

ZG005+Donafenib

Bevacizumab BIOLOGICAL

Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion, once every 3 weeks (Q3W).

ZG005+Bevacizumab

Eligibility Criteria

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

You may qualify if:

• Male or female ≥18 years of age.
• Fully understand the study and voluntarily sign the informed consent form.
• Histologically or cytologically confirmed diagnosis of metastatic or unresectable hepatocellular carcinoma (HCC).
• Life expectancy \>= 3 months.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

You may not qualify if:

• Fibrolamellar or sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
• Patients were deemed unsuitable for participating in the studyl by the investigator for any reasons.

Sponsors & Collaborators

• Changsha Taihe Hospital: lead

Study Sites (1)

Changsha Taihe Hospital

Changsha, Hunan, China

Location

MeSH Terms

Interventions

Injections; donafenib; Bevacizumab

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Xiaoli Chai

  Changsha Taihe Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongsheng Chu

CONTACT

+8651257309965; chuys@zelgen.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: January 31, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)