Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05584800

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Advanced Solid Tumor

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location status: Recruiting

Location contact

Jianming Xu

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Tolerability of ZGGS18

    Time frame: 28 days

    Dose limiting toxicity, number of participants with abnormal laboratory values and/or adverse events that are related to treatment

  2. Safety of ZGGS18

    Time frame: Through study completion, an expected average of 3 years

    Number of participants with adverse events/abnormal laboratory values that are related to treatment

Secondary outcomes

  1. Pharmacokinetic characteristics of ZGGS18

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

    Peak Plasma Concentration (Cmax)

  2. Pharmacokinetic characteristics of ZGGS18

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

    Time to maximum concentration (Tmax)

  3. Pharmacokinetic characteristics of ZGGS18

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

    Clearance (CL/F)

  4. Pharmacokinetic characteristics of ZGGS18

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

    Area under drug concentration-time curve

  5. Pharmacokinetic characteristics of ZGGS18

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

    Elimination rate constant (Ke)

  6. Pharmacokinetic characteristics of ZGGS18

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

    Elimination half-life (t1/2)

  7. Immunogenicity of ZGGS18

    Time frame: Through study completion, an expected average of 3 years

    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

  8. Efficacy of ZGGS18

    Time frame: Through study completion, an expected average of 3 years

    Objective response rate

  9. Efficacy of ZGGS18

    Time frame: Through study completion, an expected average of 3 years

    Progression-free survival

  10. Efficacy of ZGGS18

    Time frame: Through study completion, an expected average of 3 years

    Disease control rate

  11. Efficacy of ZGGS18

    Time frame: Through study completion, an expected average of 3 years

    Duration of response

  12. Efficacy of ZGGS18

    Time frame: Through study completion, an expected average of 3 years

    Time to response

  13. Efficacy of ZGGS18

    Time frame: Through study completion, an expected average of 3 years

    Time to progression

Study contacts

Contact information is provided by the study sponsor or research team.

Shangdi Ning

CONTACT

[email protected]

+86-0512-57018308

Sponsors and collaborators

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Oct 18, 2022
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.