Clinical trial NCT05584800: Study of ZGGS18 in Patients With Advanced Solid Tumors
Official title: A Phase I/II Dose Escalation, Tolerability, Safety, Pharmacokinetics and Multiple Cohort Expansion Study of ZGGS18 in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumor
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2022-10-18
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Tolerability of ZGGS18
timeFrame: 28 days
measure: Safety of ZGGS18
timeFrame: Through study completion, an expected average of 3 years
Secondary outcomes:
measure: Pharmacokinetic characteristics of ZGGS18
timeFrame: Through Phase I study completion, an expected average of 1 year
measure: Pharmacokinetic characteristics of ZGGS18
timeFrame: Through Phase I study completion, an expected average of 1 year
measure: Pharmacokinetic characteristics of ZGGS18
timeFrame: Through Phase I study completion, an expected average of 1 year
measure: Pharmacokinetic characteristics of ZGGS18
timeFrame: Through Phase I study completion, an expected average of 1 year
measure: Pharmacokinetic characteristics of ZGGS18
timeFrame: Through Phase I study completion, an expected average of 1 year
measure: Pharmacokinetic characteristics of ZGGS18
timeFrame: Through Phase I study completion, an expected average of 1 year
measure: Immunogenicity of ZGGS18
timeFrame: Through study completion, an expected average of 3 years
measure: Efficacy of ZGGS18
timeFrame: Through study completion, an expected average of 3 years
measure: Efficacy of ZGGS18
timeFrame: Through study completion, an expected average of 3 years
measure: Efficacy of ZGGS18
timeFrame: Through study completion, an expected average of 3 years
measure: Efficacy of ZGGS18
timeFrame: Through study completion, an expected average of 3 years
measure: Efficacy of ZGGS18
timeFrame: Through study completion, an expected average of 3 years
measure: Efficacy of ZGGS18
timeFrame: Through study completion, an expected average of 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
name: Jason Wu
role: STUDY_DIRECTOR
References: