Study of ZG005 in Combination With Paclitaxel＋Platinum-based ± Bevacizumab in Patients With Advanced Cervical Carcinoma

Zelgen Biopharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Cervical Carcinoma

Treatments: Drug: ZG005 Powder for Injection; Biological: Bevacizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06241235

ZG005-003

Details and patient eligibility

About

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

Enrollment: 48 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Part 1: Dose Escalation

Experimental group

Description:

Part 1 is a dose escalation study of ZG005 combined with paclitaxel and platinum-based ± bevacizumab to evaluate the tolerability and safety of the combination regimen

Treatment:

Biological: Bevacizumab

Drug: Cisplatin

Drug: Paclitaxel

Drug: Carboplatin

Drug: ZG005 Powder for Injection

Part 2: Dose Expansion

Experimental group

Description:

Part 2 is a dose expansion study to further evaluate the initial efficacy and safety of the combination regimen

Treatment:

Biological: Bevacizumab

Drug: Cisplatin

Drug: Paclitaxel

Drug: Carboplatin

Drug: ZG005 Powder for Injection