A Study of ZG005 in Patients With Advanced Solid Tumors

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

484 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-17

Study Completion Date

2026-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Solid Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1: Dose Escalation

The study will begin with open-label dose escalation in ZG005 monotherapy treatment to determine the Maximum tolerated dose (MTD).

Group Type EXPERIMENTAL

ZG005 Powder for Injection

Intervention Type BIOLOGICAL

The dose groups of ZG005 for dose escalations are set as 0.3 mg/kg, 1mg/kg, 3mg/kg, 10mg/kg, and 20mg/kg, intravenous infusion, once every 3 weeks.

Part 2: Dose Expansion: Recommended Phase 2 Dose (RP2D) of ZG005 monotherapy

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

Group Type EXPERIMENTAL

ZG005 Powder for Injection

Intervention Type BIOLOGICAL

Recommended Phase 2 Dose (RP2D) of ZG005 monotherapy, intravenous infusion, once every 3 weeks.

Interventions

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ZG005 Powder for Injection

The dose groups of ZG005 for dose escalations are set as 0.3 mg/kg, 1mg/kg, 3mg/kg, 10mg/kg, and 20mg/kg, intravenous infusion, once every 3 weeks.

Intervention Type BIOLOGICAL

ZG005 Powder for Injection

Recommended Phase 2 Dose (RP2D) of ZG005 monotherapy, intravenous infusion, once every 3 weeks.

Intervention Type BIOLOGICAL

Other Intervention Names

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ZG005 ZG005

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No