Study of ZGGS18 in Combination With ZG005 in Patients With Advanced Solid Tumors

NCT ID: NCT06938880

Last Updated: 2026-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-20

Study Completion Date

2028-04-30

Brief Summary

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This trial is designed to assess the tolerability, safety, pharmacokinetic profile, and preliminary efficacy of the combination of ZGGS18 and ZG005 in patients with advanced solid tumors, including advanced cervical cancer, hepatocellular carcinoma, neuroendocrine cancer, and lung cancer.

Detailed Description

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Conditions

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Advanced Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 1 Dose Escalation

ZG005 will be given 10mg/kg or 20mg/kg or other dose every three weeks and ZGGS18 will be given 10 mg/kg every three weeks

Group Type EXPERIMENTAL

ZGGS18 for Injection

Intervention Type BIOLOGICAL

Intravenous infusion

ZG005 for Injection

Intervention Type BIOLOGICAL

Intravenous infusion

Phase 2 Dose Expansion

ZG005 will be given RP2D every three weeks and ZGGS18 will be given 10 mg/kg every three weeks

Group Type EXPERIMENTAL

ZGGS18 for Injection

Intervention Type BIOLOGICAL

Intravenous infusion

ZG005 for Injection

Intervention Type BIOLOGICAL

Intravenous infusion

Interventions

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ZGGS18 for Injection

Intravenous infusion

Intervention Type BIOLOGICAL

ZG005 for Injection

Intravenous infusion

Intervention Type BIOLOGICAL

Other Intervention Names

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ZGGS18 ZG005

Eligibility Criteria

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Inclusion Criteria

* Fully understand this study and voluntarily sign the ICF.
* Age 18-75 years, no gender restriction.
* Patients with advanced solid tumors who have failed standard treatment or are intolerant to standard treatment, as confirmed by histopathology or cytology.

Exclusion Criteria

* Medical history, CT scan, or MRI indicates the presence of CNS metastases.
* Other malignancies within 5 years.
* Any other reason deeming the participant unsuitable for the study, as judged by the investigator.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suzhou Zelgen Biopharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason Wu

Role: STUDY_CHAIR

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Locations

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Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Siqi Jia

Role: CONTACT

+86-0512-57018310

Facility Contacts

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Li Zhang

Role: primary

Other Identifiers

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ZGGS18-ZG005-001

Identifier Type: -

Identifier Source: org_study_id

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