Study of ZG005 in Patients With Advanced Solid Tumors

A Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of ZG005 in Patients With Advanced Solid Tumors

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06927687

Enrollment

Registered

2025-04-15

Start date

2025-06-13

Completion date

2027-06-01

Last updated

2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumor

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.

Interventions

BIOLOGICALZG005 for Injection

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
Objective response rate(ORR)	Up to 2 years

Secondary

Measure	Time frame
Adverse Event (AE)	Up to 2 years

Countries

China

Contacts

STUDY_CHAIRJason Wu

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026