Study of ZG0895.HCl in Patients With Advanced Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd
About this trial
The primary objective of this study is to assess the tolerability and safety of ZG0895.HCl, and to assess the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) of ZG0895.HCl.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Fully understand the study and voluntarily sign the informed consent form(ICF).
Age ≥ 18 and ≤ 75 years old at the time of signing the ICF, either male or female;
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Life expectancy ≥ 3 months.
Disqualifiers
Previously treated with systemic TLR7/8 immunomodulators.
Any other investigational product treatment within 4 weeks before the first dosing.
Chemotherapy, biotherapy, endocrine therapy (except for hormone replacement), and biological targeted medicines within 4 weeks before the first dosing. Local palliative radiotherapy, traditional Chinese medicine with anti-tumor effect, and small molecule targeted therapy within 2 weeks (or 5 half-lives, whichever is longer) before the first dosing.
Major surgery within 4 weeks before the first dosing for any reason (excluding puncture biopsy), or need to undergo elective surgery during the trial.
Trial design
Design model
Single group
Treatments tested in this trial
ZG0895 Hydrochloride for Injection
DrugThe dose escalation of ZG0895.HCl is set as 0.06, 0.12, 0.18, 0.37, 0.75, 1.50, 2.25, 3.00, and 3.75 mg/m\^2 groups, subcutaneous (SC) injection once a week (QW)
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Part1：Dose EscalationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The incidence of dose-limiting toxicity (DLT)
DLT is defined as any of the following adverse events (AE) occurring from the first dose of Day 1 to Day 21, unless the investigator deems that the AE is clearly related to the disease progress or definitely due to an external cause. Delayed DLTs are adverse events that meet the criteria of DLTs that occur after Cycle 1. All AEs will be graded according to the US National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0), except for cytokine release syndrome (CRS)
Time frame
Up to Day 212
The maximum tolerated dose (MTD) of ZG0895.HCl
During the dose-escalation stage, if there is a first occurrence that ≥ 2 participants in a dose group experience DLT, then the dose level will be considered to be an intolerable dose, and the previous lower dose will be considered to be the MTD. The MTD group should have at least 6 evaluable participants.
Time frame
Up to Day 213
Number of Participants Experiencing Adverse Events (AEs)
Time frame
Up to 3 Years4
Number of Participants Experiencing Serious Adverse Events (SAEs)
Time frame
Up to 3 YearsSecondary outcomes
1
Overall Response Rate (ORR) as assessed by the investigator
Time frame
Up to 3 YearsSponsors and contacts
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Source ClinicalTrials.gov