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

Zelgen Biopharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Solid Tumor

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06239298

ZG005-002

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Dose Exploration

Experimental group

Description:

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.

Treatment:

Drug: Donafenib Tosilate Tablets

Drug: ZG005 Powder for Injection

Dose Expansion

Experimental group

Description:

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.

Treatment:

Drug: Donafenib Tosilate Tablets

Drug: ZG005 Powder for Injection