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

NCT06239298 | Recruiting Phase 1

• 1 other identifier: ZG005-002
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

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 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 Outcomes (1)

• Duration of response (DOR)

  Up to 2 years

Study Arms (2)

Dose Exploration

EXPERIMENTAL

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; Drug: Donafenib Tosilate Tablets

Dose Expansion

EXPERIMENTAL

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; Drug: Donafenib Tosilate Tablets

Interventions

ZG005 Powder for Injection DRUG

intravenous infusion(IV), once every 3 weeks

Also known as: ZG005

Dose Expansion; Dose Exploration

Donafenib Tosilate Tablets 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

Also known as: Donafenib

Dose Expansion; Dose Exploration

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

The Second Affiliated Hospital of Army Medical University

Chongqing, Chongqing Municipality, China

RECRUITING

MeSH Terms

Interventions

Injections; donafenib

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jason Wu

  Suzhou Zelgen Biopharmaceuticals Co.,Ltd

  STUDY CHAIR

Central Study Contacts

Cheng Wei

CONTACT

+86-0512-57309965; weic@zelgen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 2, 2024
• Study Start: May 10, 2024
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)