A Study of ZG005 in Patients With Advanced Solid Tumors

NCT06233292 | Recruiting Phase 1

• 1 other identifier: ZG005-001
• Study Type: interventional
• Target: 484
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center, open-label, Phase 1/2 study of ZG005 for the treatment of subjects with advanced solid tumors, and consists of three stages: dose escalation and confirmation of MTD/recommended dose.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (4)

• Dose Limiting Toxicities (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 21Days

• Adverse Event (AE)

  Number of participants with adverse events that are related to treatment

  Up to 24 Months

• Objective Response Rate

  Objective response rate was based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)

  Up to 24 Months

• Maximum tolerated dose (MTD)

  During the dose escalation stage, if 2 of up to 6 subjects in the first dose groups experienced DLT, then the dose level will be considered to be an intolerable dose or DLT dose level, and the previous lower dose will be considered to be the MTD.

  Up to 24 Months

Study Arms (2)

Part 1: Dose Escalation

EXPERIMENTAL

The study will begin with open-label dose escalation in ZG005 monotherapy treatment to determine the Maximum tolerated dose (MTD).

Biological: ZG005 Powder for Injection

Part 2: Dose Expansion: Recommended Phase 2 Dose (RP2D) of ZG005 monotherapy

EXPERIMENTAL

The dose-expansion stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage.Single drug dose expansion was performed in different tumors, such as :Non-small cell lung cancer, small cell lung cancer, Esophageal squamous cell carcinoma, Alveolar soft part sarcoma

Biological: ZG005 Powder for Injection

Interventions

ZG005 Powder for Injection BIOLOGICAL

The dose groups of ZG005 for dose escalations are set as 0.3 mg/kg, 1mg/kg, 3mg/kg, 10mg/kg, and 20mg/kg, intravenous infusion, once every 3 weeks.

Also known as: ZG005

Part 1: Dose Escalation

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 0-2;
• Life expectancy ≥ 3 months;
• Histologically or cytologically confirmed diagnosis of advanced solid tumors.

You may not qualify if:

• Medical history, computed tomography (CT) or magnetic resonance imaging (MRI) results indicate that existence of the central nervous system(CNS) metastases;
• Any other malignancy within 5 years.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jason Wu

  Suzhou Zelgen Biopharmaceuticals Co.,Ltd

  STUDY CHAIR

Central Study Contacts

Yongsheng Chu

CONTACT

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

Study Design

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

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 31, 2024
• Study Start: June 17, 2022
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)