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

NCT06241235 | Recruiting Phase 1

• 1 other identifier: ZG005-003
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cervical Carcinoma

Outcome Measures

Primary Outcomes (2)

• Dose Limiting Toxicity (DLT)

  Up to 2 years

• Objective Response Rate (ORR)

  ORR was defined as the percentage of the participants in the analysis population who have a Complete Response or a Partial Response. The ORR per RECIST 1.1 as assessed by Investigator is presented.

  Up to 2 years

Study Arms (2)

Part 1: Dose Escalation

EXPERIMENTAL

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

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

Part 2: Dose Expansion

EXPERIMENTAL

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

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

Interventions

ZG005 Powder for Injection DRUG

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.

Also known as: ZG005

Part 1: Dose Escalation; Part 2: Dose Expansion

Paclitaxel DRUG

IV infusion

Part 1: Dose Escalation; Part 2: Dose Expansion

Bevacizumab BIOLOGICAL

IV infusion

Part 1: Dose Escalation; Part 2: Dose Expansion

Cisplatin DRUG

IV infusion

Part 1: Dose Escalation; Part 2: Dose Expansion

Carboplatin DRUG

IV infusion

Part 1: Dose Escalation; Part 2: Dose Expansion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients were deemed unsuitable for participating in the study by the investigator for any reasons.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

Zhejiang Cancer Hospital

Zhejiang, Hangzhou, 310022, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Injections; Paclitaxel; Bevacizumab; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes

Study Officials

• Jason Wu

  Suzhou Zelgen Biopharmaceuticals Co.,Ltd

  STUDY CHAIR

Central Study Contacts

Yongsheng Chu

CONTACT

+8651257309965; chuys@zelgen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 5, 2024
• Study Start: March 27, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)