A Study of ZG005 in Patients With Advanced Solid Tumors

Z

Zelgen Biopharmaceuticals

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Solid Tumors

Treatments

Biological: ZG005 Powder for Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT06233292
ZG005-001

Details and patient eligibility

About

This is a multi-center, open-label, Phase 1/2 study of ZG005 for the treatment of subjects with advanced solid tumors, and consists of three stages: dose escalation and confirmation of MTD/recommended dose.

Enrollment

484 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Fully understand the study and voluntarily sign the informed consent form.
  • Male or female 18-70 years of age;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2;
  • Life expectancy ≥ 3 months;
  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

484 participants in 2 patient groups

Part 1: Dose Escalation
Experimental group
Description:
The study will begin with open-label dose escalation in ZG005 monotherapy treatment to determine the Maximum tolerated dose (MTD).
Treatment:
Biological: ZG005 Powder for Injection
Biological: ZG005 Powder for Injection
Part 2: Dose Expansion: Recommended Phase 2 Dose (RP2D) of ZG005 monotherapy
Experimental group
Description:
The dose-expansion stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage.Single drug dose expansion was performed in different tumors, such as :Non-small cell lung cancer, small cell lung cancer, Esophageal squamous cell carcinoma, Alveolar soft part sarcoma
Treatment:
Biological: ZG005 Powder for Injection
Biological: ZG005 Powder for Injection

Trial contacts and locations

1

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Central trial contact

Yongsheng Chu

Data sourced from clinicaltrials.gov

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