A Phase 1 Dose Escalation Study of ZG006 in Patients With Small Cell Lung Cancer

Part of paid clinical trials in Orange, California.

Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study ID
NCT06592638
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

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

Study Details

This is a multi-center, open-label, Phase 1 clinical study of ZG006 in the US for the treatment of subjects with small cell lung cancer who have failed or are intolerant to available standard treatment. During the dose escalation stage, a standard "3+3" design will be used to assess the MTD/ recommended dose for the subsequent studies.

Key Dates

Start date
Mar 31, 2025
Status verified
Apr 2025
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation

Primary Outcome Measure

The incidence of dose-limiting toxicity (DLT) [ Time Frame: Up to 28 days ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Zelgen Site 105OrangeCalifornia92868-
Zelgen Site 102PlantationFlorida33322-
Zelgen Site 103LexingtonKentucky40536-
Zelgen Site 101CantonOhio44718-
Zelgen Site 104ClevelandOhio44106-
Zelgen Site 106HoustonTexas77030-

Find similar trials in Orange, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Zelgen· Orange, CAZelgen· Plantation, FLZelgen· Lexington, KYZelgen· Canton, OHZelgen· Cleveland, OHZelgen· Houston, TX

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