Study of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma.

NCT06372626 | Recruiting Phase 1

• 1 other identifier: ZG005-004
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

The trial is divided into two parts. PART 1 is a dose escalation study of the ZG005 combined with Etoposide and Cisplatin, primarily assessing the tolerability and safety of this combined treatment. PART 2 is a dose expansion study, further evaluating the preliminary efficacy and safety of this combined treatment.

Conditions

Neuroendocrine Carcinoma

Outcome Measures

Primary Outcomes (3)

• 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

• Adverse Event (AE)

  Number of participants with adverse events that are related to treatment

  Up to 2 years

Study Arms (2)

Part 1: Dose Escalation

EXPERIMENTAL

Dose-escalation study of ZG005 in combination with Etoposide and Cisplatin.

Biological: ZG005; Drug: Etoposide; Drug: Cisplatin

Part 2: Dose Expansion

EXPERIMENTAL

Group A: ZG005 in combination with Etoposide and Cisplatin; Group B: Placebo in combination with Etoposide and Cisplatin.

Biological: ZG005; Drug: Etoposide; Drug: Cisplatin; Drug: Placebo

Interventions

ZG005 BIOLOGICAL

ZG005 for dose escalations are set as 10mg/kg, 20mg/kg, and the other doses after discussion. intravenous infusion, once every 3 weeks. ZG005 for dose expansion will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage.

Part 1: Dose Escalation; Part 2: Dose Expansion

Etoposide DRUG

IV infusion

Part 1: Dose Escalation; Part 2: Dose Expansion

Cisplatin DRUG

IV infusion

Part 1: Dose Escalation; Part 2: Dose Expansion

Placebo DRUG

0.9% Sodium Chloride Injection

Part 2: Dose Expansion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• 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.
• Male or female 18-70 years of age.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
• Histologically confirmed recurrent or metastatic neuroendocrine carcinoma
• Life expectancy ≥ 3 months.

You may not qualify if:

• Medical history, computed tomography or magnetic resonance imaging results indicate that existence of the central nervous system metastases;
• Any other malignancy within 5 years.
• participants 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)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Neuroendocrine

Interventions

Etoposide; Cisplatin

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Jason Wu

  Suzhou Zelgen Biopharmaceuticals Co.,Ltd

  STUDY CHAIR

Central Study Contacts

Cheng Wei

CONTACT

+8651257309965; weic@zelgen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: May 30, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)