Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Advanced Small Cell Lung Cancer

Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study ID
NCT06283719
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

This is a multicenter, open-label Phase I/II study consisting of two parts: Part 1 is a Phase I dose-escalation study of ZG006, aimed at evaluating the safety and tolerability of ZG006 in Participants with advanced small-cell lung cancer or neuroendocrine carcinoma. Upon completion of Part 1, the investigators and sponsor will jointly determine two preliminary recommended Phase II doses for Part 2, based on the available safety, preliminary efficacy, and pharmacokinetic data. Part 2 is a Phase II dose-expansion study of ZG006, designed to explore and confirm the efficacy and safety of ZG006 monotherapy in advanced small-cell lung cancer.

Key Dates

First listed
Feb 28, 2024
Start date
Sep 2, 2024
Status verified
Dec 2024
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
265 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part1 ：Dose Escalation
    A total of six dose escalations were preset: 0.1 mg, 0.3 mg, 1 mg, 3 mg, 10 mg, and 30 mg.
  • Experimental: Part2 ：Dose Expansion
    Part 2 consists of three cohorts. Cohort 1 is divided into two stages: Stage 1 is for dose optimization: approximately 30 patients will be enrolled in each of the two preliminary RP2D groups; the better-performing dose will be selected for Stage 2 based on emerging data. Stage 2 is the pivotal, registrational study, intended to enroll patients with advanced small-cell lung cancer who are in third-line or later lines of therapy.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: up to approximately 2 years ]

Central Contacts

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