Study of ZGGS18 in Patients With Advanced Solid Tumors

NCT ID: NCT05584800

Last Updated: 2026-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-15

Study Completion Date

2026-11-01

Brief Summary

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A clinical study to assess dose escalation, tolerance, safety, pharmacokinetics, and multi cohort expansion of ZGGS18 in patients with advanced solid tumors

Detailed Description

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Conditions

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Advanced Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation

Group Type EXPERIMENTAL

ZGGS18 for Injection

Intervention Type BIOLOGICAL

0.3 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg, 10 mg/kg, 15 mg/kg and 20 mg/kgof ZGGS18,intravenous infusion, once every 2 weeks.

Dose Expansion

Tumor type: colorectal cancer,pancreatic cancer

Group Type EXPERIMENTAL

ZGGS18 for Injection

Intervention Type BIOLOGICAL

Recommended Phase 2 Dose (RP2D) (to be determined) of ZGGS18,intravenous infusion, once every 2 weeks.

Interventions

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ZGGS18 for Injection

0.3 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg, 10 mg/kg, 15 mg/kg and 20 mg/kgof ZGGS18,intravenous infusion, once every 2 weeks.

Intervention Type BIOLOGICAL

ZGGS18 for Injection

Recommended Phase 2 Dose (RP2D) (to be determined) of ZGGS18,intravenous infusion, once every 2 weeks.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed diagnosis of advanced solid tumors, who had failed the available standard treatments or no standard treatment or intolerance to standard treatment;
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
* Life expectancy ≥ 3 months;
* Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors 1.1(RECIST1.1). For lesions that have received radiation therapy, only after the progression of the lesions, they can be considered measurable lesions.

Exclusion Criteria

* The investigator considers that any subjects are not suitable to participate in the trial.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suzhou Zelgen Biopharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason Wu

Role: STUDY_DIRECTOR

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Locations

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shangdi Ning

Role: CONTACT

+86-0512-57018308

Facility Contacts

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Jianming Xu

Role: primary

Other Identifiers

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ZGGS18-001

Identifier Type: -

Identifier Source: org_study_id

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