Clinical trial

A Phase I/II Study to Evaluate Safety and Pharmacokinetics and Initial Efficacy of ZG005 in Combination With Paclitaxel Plus Cisplatin/Carboplatin ± Bevacizumab in Patients With Advanced Cervical Carcinoma

ID

Name

ZG005-003

Description

This is a multicenter, open-label phase I/II study for the first-line treatment of advanced cervical cancer.

Trial arms

Trial start

2024-03-27

Estimated PCD

2026-05-01

Trial end

2026-05-01

Status

Recruiting

Phase

Early phase I

Treatment

ZG005 Powder for Injection

ZG005 for dose escalations are set as 10 mg/kg, 15 mg/kg and other doses after discussion, intravenous infusion(IV), once every 3 weeks (Q3W). ZG005 for dose-expansion stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage.

Arms:

Part 1: Dose Escalation, Part 2: Dose Expansion

Other names:

ZG005

Paclitaxel

IV infusion

Arms:

Part 1: Dose Escalation, Part 2: Dose Expansion

Bevacizumab

IV infusion

Arms:

Part 1: Dose Escalation, Part 2: Dose Expansion

Cisplatin

IV infusion

Arms:

Part 1: Dose Escalation, Part 2: Dose Expansion

Carboplatin

IV infusion

Arms:

Part 1: Dose Escalation, Part 2: Dose Expansion

Size

48

Primary endpoint

Dose Limiting Toxicity (DLT)

Up to 2 years

Objective Response Rate (ORR)

Up to 2 years

Eligibility criteria

Inclusion Criteria: * Fully understand the study and voluntarily sign the informed consent form. * Female 18-70 years of age; * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or * Life expectancy ≥ 3 months. Exclusion Criteria: * Patients were deemed unsuitable for participating in the study by the investigator for any reasons.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 48, 'type': 'ESTIMATED'}}

Updated at

2024-04-02

1 organization

5 products

1 indication

Organization

Suzhou Zelgen Biopharmaceuticals

Product

Indication

Cervical Cancer

Product

Product

Product

Product