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

NCT06938880 | Recruiting Phase 1

• 1 other identifier: ZGGS18-ZG005-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (4)

• Dose limited toxicity(DLT)

  Incidence and severity of DLT events

  up to 21 days

• Adverse Event (AE)

  Abnormal changes in clinical symptoms, vital signs, physical examination, laboratory tests, electrocardiograph and other examinations.

  Up to 2 years

• Maximum tolerated dose(MTD)

  Up to 1 years

• Recommended phase II dose(RP2D)

  Up to 1 years

Secondary Outcomes (2)

• Objective response rate (ORR)

  Up to 2 years

• Immunogenicity

  Up to 2 years

Study Arms (2)

Phase 1 Dose Escalation

EXPERIMENTAL

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

Biological: ZGGS18 for Injection; Biological: ZG005 for Injection

Phase 2 Dose Expansion

EXPERIMENTAL

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

Biological: ZGGS18 for Injection; Biological: ZG005 for Injection

Interventions

ZGGS18 for Injection BIOLOGICAL

Intravenous infusion

Also known as: ZGGS18

Phase 1 Dose Escalation; Phase 2 Dose Expansion

ZG005 for Injection BIOLOGICAL

Intravenous infusion

Also known as: ZG005

Phase 1 Dose Escalation; Phase 2 Dose Expansion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 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

Siqi Jia

CONTACT

+86-0512-57018310; jiasy@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: April 7, 2025
• First Posted: April 22, 2025
• Study Start: May 20, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: January 5, 2026

Record last verified: 2025-04

Locations

CN (1)