NCT06927687

Brief Summary

This is an open-label, multicenter, Phase II clinical trial, designed to evaluate the efficacy and safety of ZG005 in patients with advanced solid tumors who have previously failed or are intolerant to standard treatment.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
13mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Jun 2025Jun 2027

First Submitted

Initial submission to the registry

April 7, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 15, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

June 13, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

April 7, 2025

Last Update Submit

April 27, 2026

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

  • Objective response rate(ORR)

    Up to 2 years

Secondary Outcomes (1)

  • Adverse Event (AE)

    Up to 2 years

Study Arms (1)

Dose Expansion

EXPERIMENTAL

ZG005 dose expansion was performed in different tumors, such as: nasopharyngeal carcinoma, esophageal squamous cell carcinoma, and other carcinoma

Biological: ZG005 for Injection

Interventions

ZG005 for InjectionBIOLOGICAL

Recommended Phase 2 Dose (RP2D) of ZG005(20 mg/kg), intravenous infusion, once every 3 weeks.

Also known as: ZG005
Dose Expansion

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fully understand the study and voluntarily sign the informed consent form.
  • Male or female 18-75 years of age;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1;
  • Life expectancy ≥ 12 weeks;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Jason Wu

    Suzhou Zelgen Biopharmaceuticals Co.,Ltd

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2025

First Posted

April 15, 2025

Study Start

June 13, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations

CN(1)