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

A Multi-center, Open, Dose Exploration and Dose Expansion Phase I/II Study of ZG005 Combined With Donafenib Tosilate Tablets in Patients With Advanced Solid Tumor

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: ZG005 Powder for Injection; Drug: Donafenib Tosilate Tablets

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Cheng Wei; Phone Number: +86-0512-57309965; Email: weic@zelgen.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China
      • Recruiting
      • The Second Affiliated Hospital of Army Medical University
      • Contact: Bo Zhu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: ZG005 Powder for Injection; intravenous infusion(IV), once every 3 weeks; Other Names: ZG005; 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; Other Names: Donafenib
Experimental: 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.	Drug: ZG005 Powder for Injection; intravenous infusion(IV), once every 3 weeks; Other Names: ZG005; 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; Other Names: Donafenib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 2 years
Dose Limiting Toxicity (DLT)	A DLT is defined as any of the following ≥ Grade 3 adverse events occurring from the first dose to the end of first Cycle (21 days), unless the investigator deems that the AE is clearly related to the disease progress or definitely due to an external cause	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of response (DOR)	Time from the first evaluated CR or PR until PD or death from any cause	Up to 2 years

Collaborators and Investigators

• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Investigators: Study Chair: Jason Wu, Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: ZG005-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No