Study of ZGGS18 in Patients With Advanced Solid Tumors

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05584800
• Other study ID #: ZGGS18-001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 15, 2022
• Est. completion date: November 1, 2025

Study information

• Verified date: July 2023
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: Shangdi Ning
• Phone: +86-0512-57018308
• Email: ningsd[@]zelgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 222
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability of ZGGS18	Dose limiting toxicity, number of participants with abnormal laboratory values and/or adverse events that are related to treatment	28 days
Primary	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	Pharmacokinetic characteristics of ZGGS18	Peak Plasma Concentration (Cmax)	Through Phase I study completion, an expected average of 1 year
Secondary	Pharmacokinetic characteristics of ZGGS18	Time to maximum concentration (Tmax)	Through Phase I study completion, an expected average of 1 year
Secondary	Pharmacokinetic characteristics of ZGGS18	Clearance (CL/F)	Through Phase I study completion, an expected average of 1 year
Secondary	Pharmacokinetic characteristics of ZGGS18	Area under drug concentration-time curve	Through Phase I study completion, an expected average of 1 year
Secondary	Pharmacokinetic characteristics of ZGGS18	Elimination rate constant (Ke)	Through Phase I study completion, an expected average of 1 year
Secondary	Pharmacokinetic characteristics of ZGGS18	Elimination half-life (t1/2)	Through Phase I study completion, an expected average of 1 year
Secondary	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
Secondary	Efficacy of ZGGS18	Objective response rate	Through study completion, an expected average of 3 years
Secondary	Efficacy of ZGGS18	Progression-free survival	Through study completion, an expected average of 3 years
Secondary	Efficacy of ZGGS18	Disease control rate	Through study completion, an expected average of 3 years
Secondary	Efficacy of ZGGS18	Duration of response	Through study completion, an expected average of 3 years
Secondary	Efficacy of ZGGS18	Time to response	Through study completion, an expected average of 3 years
Secondary	Efficacy of ZGGS18	Time to progression	Through study completion, an expected average of 3 years