Study of ZGGS18 in Patients With Advanced Solid Tumors

A Phase I/II Dose Escalation, Tolerability, Safety, Pharmacokinetics and Multiple Cohort Expansion Study of ZGGS18 in Patients With Advanced Solid Tumors

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

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Biological: ZGGS18 for Injection; Biological: ZGGS18 for Injection

• Study Type: Interventional
• Enrollment (Estimated): 222
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Shangdi Ning; Phone Number: +86-0512-57018308; Email: ningsd@zelgen.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100853
      • Recruiting
      • Chinese PLA General Hospital
      • Contact: Jianming Xu; Email: Jianmingxu2014@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Escalation	Biological: 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.; Biological: ZGGS18 for Injection; Recommended Phase 2 Dose (RP2D) (to be determined) of ZGGS18，intravenous infusion, once every 2 weeks.
Experimental: Dose Expansion; Tumor type: colorectal cancer，pancreatic cancer	Biological: 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.; Biological: ZGGS18 for Injection; Recommended Phase 2 Dose (RP2D) (to be determined) of ZGGS18，intravenous infusion, once every 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability of ZGGS18	Dose limiting toxicity, number of participants with abnormal laboratory values and/or adverse events that are related to treatment	28 days
Safety of ZGGS18	Number of participants with adverse events/abnormal laboratory values that are related to treatment	Through study completion, an expected average of 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic characteristics of ZGGS18	Peak Plasma Concentration (Cmax)	Through Phase I study completion, an expected average of 1 year
Pharmacokinetic characteristics of ZGGS18	Time to maximum concentration (Tmax)	Through Phase I study completion, an expected average of 1 year
Pharmacokinetic characteristics of ZGGS18	Clearance (CL/F)	Through Phase I study completion, an expected average of 1 year
Pharmacokinetic characteristics of ZGGS18	Area under drug concentration-time curve	Through Phase I study completion, an expected average of 1 year
Pharmacokinetic characteristics of ZGGS18	Elimination rate constant (Ke)	Through Phase I study completion, an expected average of 1 year
Pharmacokinetic characteristics of ZGGS18	Elimination half-life (t1/2)	Through Phase I study completion, an expected average of 1 year
Immunogenicity of ZGGS18	Detection of anti-drug antibodies, if positive, further detection of neutralizing antibodies. Counting the number of patients and incidence of anti-drug antibodies and neutralizing antibodies	Through study completion, an expected average of 3 years
Efficacy of ZGGS18	Objective response rate	Through study completion, an expected average of 3 years
Efficacy of ZGGS18	Progression-free survival	Through study completion, an expected average of 3 years
Efficacy of ZGGS18	Disease control rate	Through study completion, an expected average of 3 years
Efficacy of ZGGS18	Duration of response	Through study completion, an expected average of 3 years
Efficacy of ZGGS18	Time to response	Through study completion, an expected average of 3 years
Efficacy of ZGGS18	Time to progression	Through study completion, an expected average of 3 years

Collaborators and Investigators

• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Investigators: Study Director: Jason Wu, Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: October 10, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (Actual): October 18, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• Other Study ID Numbers: ZGGS18-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No