Actively Recruiting
Study of ZG0895.HCl in Patients With Advanced Solid Tumors
Led by Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Updated on 2024-03-06
60
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of ZG0895.HCl in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fully understand the study and voluntarily sign the informed consent form
- Age 18 to 75 years at the time of signing the consent
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy of at least 3 months
- All side effects from previous treatments have returned to baseline or are Grade 1 or lower on CTCAE 5.0 (except certain non-risk side effects)
- Participants and partners agree to use reliable contraception during treatment and for at least 6 months after last dose, unless postmenopausal or surgically sterilized
- For previously radiated lesions, only those with progression can be measured
- At least 1 measurable lesion per RECIST v1.1
- Histologically or cytologically confirmed advanced solid tumors with failed or intolerable standard treatments
You will not qualify if you...
- Previous treatment with systemic TLR7/8 immunomodulators
- Use of other investigational products within 4 weeks before first dose
- Chemotherapy, biotherapy, endocrine therapy (except hormone replacement), or biological targeted medicines within 4 weeks before first dose
- Local palliative radiotherapy, traditional Chinese medicine with anti-tumor effects, or small molecule targeted therapy within 2 weeks before first dose
- Major surgery within 4 weeks before first dose (except puncture biopsy) or need for elective surgery during trial
- Use of potent CYP3A4/5 inducers or inhibitors within 2 weeks before first dose
- Use of systemic immunosuppressive drugs or other immunomodulators within 2 weeks before first dose
- Grade 3 or higher immune-related adverse events after immunotherapy
- Blood and organ function abnormalities within 7 days before first dose, including low blood counts, high liver enzymes, low albumin, impaired kidney function, abnormal clotting tests, or high urine protein
- Symptomatic central nervous system metastases or meningeal metastases not well controlled
- Uncontrollable third cavity effusion requiring repeated drainage
- History of neurological disorders affecting brain function such as epilepsy or dementia
- Severe cardiac or cerebrovascular disease including recent heart attack, stroke, heart failure, uncontrolled hypertension, or prolonged QTcF interval
- Active or history of autoimmune diseases except stable autoimmune thyroid diseases
- Active infection requiring systemic therapy within 7 days before first dose or active hepatitis B/C or HIV infection
- Prior allogeneic stem cell or solid organ transplantation
- Known allergy to ZG0895.HCl or severe allergy history
- Pregnant or nursing females
- Any other condition deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Zhejiang, Hangzhou, China, 310022
Actively Recruiting
Research Team
W
Wenhao Cai
CONTACT
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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