NCT07038096

Brief Summary

This study is a randomized, multicenter, Phase Ib/II clinical trial, aimed at evaluating the efficacy and safety of the combination of ZG006 and ZG005 in patients with advanced small cell lung cancer and neuroendocrine carcinoma.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for phase_1

Timeline
16mo left

Started Sep 2025

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress32%
Sep 2025Sep 2027

First Submitted

Initial submission to the registry

June 18, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 26, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

September 23, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

1.9 years

First QC Date

June 18, 2025

Last Update Submit

December 30, 2025

Conditions

Neuroendocrine CarcinomaSmall Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

  • Number of Participants Who Experienced Dose-limiting Toxicity (DLT)

    up to 28 days

  • Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Up to 2 years

  • Objective Response Rate (ORR)

    The objective response rate was defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) based on the modified RECIST v1.1.

    Up to 2 years

Secondary Outcomes (4)

  • Duration of Response (DOR)

    Up to 2 years

  • Disease Control Rate (DCR)

    Up to 2 years

  • Progression-free Survival (PFS)

    Up to 2 years

  • Overall Survival (OS)

    Up to 2 years

Study Arms (3)

Phase Ib: Part1-Dose Escalation

EXPERIMENTAL

This study will employ the traditional "3+3" dose escalation design. Ultimately, two combination dosing cohorts will be selected to enter Part 2, the dose expansion phase, based on a comprehensive evaluation of the safety and pharmacokinetic (PK) data obtained by the investigators and the sponsor.

Drug: ZG006Drug: ZG005

Phase Ib: Part2-Dose Expansion

EXPERIMENTAL

The safety and pharmacokinetic (PK) data obtained in Part 1 will be used to determine two expansion phase doses of the ZG006 and ZG005 combination. The dose expansion study will further evaluate the efficacy of the two selected combination dosing cohorts in patients with advanced small cell lung cancer and neuroendocrine carcinoma.

Drug: ZG006Drug: ZG005

Phase II

EXPERIMENTAL

Participants will receive the RP2D of ZG006 in combination with ZG005 identified in Phase Ib of the study.

Drug: ZG006Drug: ZG005

Interventions

ZG006DRUG

ZG006 will be administered as an intravenous (IV) infusion.

Phase IIPhase Ib: Part1-Dose EscalationPhase Ib: Part2-Dose Expansion
ZG005DRUG

ZG005 will be administered as an intravenous (IV) infusion.

Phase IIPhase Ib: Part1-Dose EscalationPhase Ib: Part2-Dose Expansion

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.
  • Participants with advanced small cell lung cancer or neuroendocrine carcinoma confirmed by histopathology or cytology.
  • Eastern Cooperative Oncology Group (ECOG) 0 to 1.
  • Life expectancy \> 3 months.

You may not qualify if:

  • The investigator believes that the subject has other reasons that make them unsuitable for participation in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guanzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung CarcinomaCarcinoma, Neuroendocrine

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Jason Wu

    Suzhou Zelgen Biopharmaceuticals Co.,Ltd

    STUDY CHAIR

Central Study Contacts

Hewen Yin

CONTACT

+86-0512-57309965yinhw@zelgen.com

Study Design

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

Study Record Dates

First Submitted

June 18, 2025

First Posted

June 26, 2025

Study Start

September 23, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

January 5, 2026

Record last verified: 2025-12

Locations

CN(1)