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

Zelgen Biopharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Biological: ZG005 for Injection; Biological: ZGGS18 for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06938880

ZGGS18-ZG005-001

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Phase 1 Dose Escalation

Experimental group

Description:

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

Treatment:

Biological: ZGGS18 for Injection

Biological: ZG005 for Injection

Phase 2 Dose Expansion

Experimental group

Description:

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

Treatment:

Biological: ZGGS18 for Injection

Biological: ZG005 for Injection