Study of ZGGS18 in Patients With Advanced Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd
About this trial
A clinical study to assess dose escalation, tolerance, safety, pharmacokinetics, and multi cohort expansion of ZGGS18 in patients with advanced solid tumors
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
The investigator considers that any subjects are not suitable to participate in the trial.
Trial design
Design model
Sequential
Treatments tested in this trial
ZGGS18 for Injection
Biological/Vaccine0.3 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
Biological/VaccineRecommended Phase 2 Dose (RP2D) (to be determined) of ZGGS18，intravenous infusion, once every 2 weeks.
Treatment groups
222 Participants
are divided into 2 treatment groupsGroup A: Dose EscalationExperimental treatment 1 intervention
Group B: Dose ExpansionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Tolerability of ZGGS18
Dose limiting toxicity, number of participants with abnormal laboratory values and/or adverse events that are related to treatment
Time frame
28 days2
Safety of ZGGS18
Number of participants with adverse events/abnormal laboratory values that are related to treatment
Time frame
Through study completion, an expected average of 3 yearsSecondary outcomes
1
Pharmacokinetic characteristics of ZGGS18
Peak Plasma Concentration (Cmax)
Time frame
Through Phase I study completion, an expected average of 1 year2
Pharmacokinetic characteristics of ZGGS18
Time to maximum concentration (Tmax)
Time frame
Through Phase I study completion, an expected average of 1 year3
Pharmacokinetic characteristics of ZGGS18
Clearance (CL/F)
Time frame
Through Phase I study completion, an expected average of 1 year4
Pharmacokinetic characteristics of ZGGS18
Area under drug concentration-time curve
Time frame
Through Phase I study completion, an expected average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov