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

Phase 1

Recruiting

• Conditions: Solid Tumor
• Interventions: Drug: ZG005 Powder for Injection; Drug: Donafenib Tosilate Tablets

• Registration Number: NCT06239298
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-25
• Study First Submitted QC: 2024-01-25
• Study First Posted: 2024-02-02
• Study Start: 2024-05-10
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-13
• Last Update Posted: 2024-06-14
• Primary Completion: 2026-03
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose Exploration	Donafenib Tosilate Tablets	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.
Dose Expansion	ZG005 Powder for Injection	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.
Dose Expansion	Donafenib Tosilate Tablets	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.
Dose Exploration	ZG005 Powder for Injection	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.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Up to 2 years	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.
Dose Limiting Toxicity (DLT)	Up to 2 years	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

Secondary Outcome Measures

Name	Time	Method
Duration of response (DOR)	Up to 2 years	Time from the first evaluated CR or PR until PD or death from any cause

Trial Locations

Locations (1)

The Second Affiliated Hospital of Army Medical University; 🇨🇳 Chongqing, Chongqing, China