A Study of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor

NCT ID: NCT06239298

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-10
• Study Completion Date: 2026-05-31

Brief Summary

This is a Multi-center, Open-labe, Phase I/II Study to evaluate the safety and tolerability of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor.

Conditions

Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Exploration

The first stage is a dose-exploration study of ZG005 combined with Donafenib to evaluate the safety and tolerability of different dose combinations in patients with advanced solid tumors who have failed standard therapy.

Group Type: EXPERIMENTAL

ZG005 Powder for Injection

Intervention Type: DRUG

intravenous infusion(IV), once every 3 weeks

Donafenib Tosilate Tablets

Intervention Type: DRUG

The dose groups of Donafenib for dose-exploration stage are set as 0.2g BID, 0.1g BID, and 0.1g QD, oral administration.The dose-expansion stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage

Dose Expansion

The second stage is a dose-expansion study to further evaluate the safety and initial efficacy of the combination regimen in hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and other potentially beneficial solid tumors.

Group Type: EXPERIMENTAL

ZG005 Powder for Injection

Intervention Type: DRUG

intravenous infusion(IV), once every 3 weeks

Donafenib Tosilate Tablets

Intervention Type: DRUG

The dose groups of Donafenib for dose-exploration stage are set as 0.2g BID, 0.1g BID, and 0.1g QD, oral administration.The dose-expansion stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage

Interventions

ZG005 Powder for Injection

intravenous infusion(IV), once every 3 weeks

Intervention Type: DRUG

Donafenib Tosilate Tablets

The dose groups of Donafenib for dose-exploration stage are set as 0.2g BID, 0.1g BID, and 0.1g QD, oral administration.The dose-expansion stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage

Intervention Type: DRUG

Other Intervention Names

ZG005; Donafenib

Eligibility Criteria

Inclusion Criteria

• Fully understand the study and voluntarily sign the informed consent form.
• Male or female 18-70 years of age;
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
• Life expectancy ≥ 3 months.

Exclusion Criteria

• Patients were deemed unsuitable for participating in the study by the investigator for any reasons.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason Wu

Role: STUDY_CHAIR

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Locations

The Second Affiliated Hospital of Army Medical University

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Cheng Wei

Role: CONTACT

weic@zelgen.com

+86-0512-57309965

Facility Contacts

Bo Zhu

Role: primary

Other Identifiers

ZG005-002

Identifier Type: -

Identifier Source: org_study_id