Actively Recruiting
Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of ZX-8177 in Patients With Advanced Solid Tumors
Led by Nanjing Zenshine Pharmaceuticals · Updated on 2026-01-02
80
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an open-label, multicenter, phase I clinical trial involving dose escalation and dose expansion of ZX-8177 in patients with advanced unresectable, recurrent, or metastatic solid tumors. The study consists of two stages: dose escalation and dose expansion. It primarily aims to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), biomarkers, and preliminary efficacy of ZX-8177 as a monotherapy with continuous administration in Chinese patients with advanced solid tumors who have failed standard treatment or lack standard treatment options. The study also seeks to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD)/optimal biological dose (OBD), or recommended phase II dose (RP2D).
CONDITIONS
Official Title
Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of ZX-8177 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Age 18 years or older
- Expected survival of at least 3 months
- ECOG performance status of 0 or 1
- Diagnosed with advanced malignant solid tumors without effective standard treatments or resistant/intolerant to such treatments
- Have at least one measurable lesion not previously irradiated or showing progression after radiotherapy
- Adequate kidney function: serum creatinine ≤1.5 times upper limit of normal or creatinine clearance ≥50 mL/min; urine protein ≤1+ or 24-hour urine protein <1 g if higher
- Adequate liver function: AST and ALT ≤2.5 times upper limit of normal (≤4 times if liver involved); total bilirubin ≤1.5 times upper limit of normal (≤3 times if Gilbert's syndrome); coagulation parameters INR and APTT ≤1.5 times upper limit of normal if not on anticoagulants
- Adequate bone marrow function: ANC >1.5×10⁹/L; hemoglobin ≥90 g/L; platelets ≥90×10⁹/L; no recent use of medications to boost white cells or platelets
- Female patients of childbearing potential must have a negative pregnancy test
- Females not of childbearing potential must meet criteria such as hysterectomy, bilateral oophorectomy/salpingectomy, or confirmed postmenopause
- Females of childbearing potential and male partners must agree to use effective contraception during and after the study
- Males must agree to avoid sperm donation during and after the study
You will not qualify if you...
- Previous treatment with ENPP1 inhibitors or STING agonists
- Anti-tumor drug treatment within 28 days before starting study drug (with some exceptions)
- History of grade 3 or higher immune-related adverse events during prior immunotherapy
- Radiotherapy within 14 days before study drug administration, except allowed palliative radiotherapy
- Participation in other interventional clinical trials within 1 month or less than 5 half-lives
- History of organ transplantation requiring immunosuppression
- Major surgery requiring general anesthesia or unresolved postoperative complications within specified periods
- Adverse reactions from prior therapy or surgery complications greater than grade 1
- Vaccinations with live, inactivated, or attenuated vaccines within 30 days before first dose
- Symptomatic central nervous system metastases or carcinomatous meningitis
- History of another malignancy within past 5 years except certain treated cases
- Uncontrolled electrolyte disturbances
- Dysphagia
- Clinically uncontrolled pleural, pericardial effusion or ascites
- Systemic immunosuppressive medication within 2 weeks before study drug
- Significant active cardiac disease or history including long QT syndrome, arrhythmias, heart failure, and others
- Poorly controlled hypertension or high hemoglobin A1c
- Active infections including HIV, hepatitis B or C, tuberculosis, and others with some exceptions and monitoring
- Known liver diseases including drug-induced injury, chronic hepatitis, cirrhosis, and others
- Severe lung diseases
- Gastrointestinal dysfunction limiting drug absorption
- Psychiatric disorders or substance abuse
- Pregnant or breastfeeding
- Allergic constitution or severe allergy history
- Intolerance to venipuncture
- History of autoimmune diseases except certain stable conditions
- Expected to receive other systemic anti-tumor therapies during study
- Taking known inhibitors of certain transporters and unable to discontinue
- Any other condition deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai GoBroad Cancer Hospital
Shanghai, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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