Study of ZGGS18 in Patients With Advanced Solid Tumors

NCT05584800 | Recruiting Phase 1

• 1 other identifier: ZGGS18-001
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Pharmacokinetic characteristics of ZGGS18

  Through Phase I study completion, an expected average of 1 year

• Pharmacokinetic characteristics of ZGGS18

  Through Phase I study completion, an expected average of 1 year

• Pharmacokinetic characteristics of ZGGS18

  Through Phase I study completion, an expected average of 1 year

• Pharmacokinetic characteristics of ZGGS18

  Through Phase I study completion, an expected average of 1 year

• Pharmacokinetic characteristics of ZGGS18

  Through Phase I study completion, an expected average of 1 year

Study Arms (2)

Dose Escalation

EXPERIMENTAL

Biological: ZGGS18 for Injection

Dose Expansion

EXPERIMENTAL

Tumor type: colorectal cancer，pancreatic cancer

Biological: ZGGS18 for Injection

Interventions

ZGGS18 for Injection 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 Escalation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• The investigator considers that any subjects are not suitable to participate in the trial.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jason Wu

  Suzhou Zelgen Biopharmaceuticals Co.,Ltd

  STUDY DIRECTOR

Central Study Contacts

Shangdi Ning

CONTACT

+86-0512-57018308; ningsd@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: October 10, 2022
• First Posted: October 18, 2022
• Study Start: November 15, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)