Actively Recruiting
A Phase I/II Clinical Study in Patients with Advanced Solid Tumor.
Led by Beijing Tide Pharmaceutical Co., Ltd · Updated on 2025-03-21
56
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a 2-part, phase I/II, open-label, multicenter study designed to evaluate the safety, PK, PD and preliminary efficacy of TCC1727 tablets administered orally QD.
CONDITIONS
Official Title
A Phase I/II Clinical Study in Patients with Advanced Solid Tumor.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 18 to 70 years
- Provided voluntary informed consent and agree to follow study protocol
- Histologically or cytologically confirmed advanced solid tumors progressed on or intolerant to standard therapy or no effective standard therapy exists
- Phase I: all tumor types eligible; Phase II: patients with DNA damage response defects detected centrally
- At least one measurable lesion per RECIST 1.1 criteria for phase II; phase I may include assessable lesions without measurable lesions if investigator agrees
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy of at least 12 weeks
- QTcF less than 450 milliseconds on 12-lead ECG
- Laboratory values: ANC >= 1.5 x 10^9/L, platelets >= 100 x 10^9/L, hemoglobin >= 9.0 g/L
- No blood transfusion or hematopoietic stimulating factors within 14 days
- Bilirubin total <= 1.5 times upper limit of normal (ULN)
- ALT and AST <= 3 times ULN (or <= 5 times ULN if liver metastasis present)
- Creatinine clearance >= 60 mL/min by Cockcroft-Gault formula or measured 24-hour clearance >= 50 mL/min
- INR and APTT <= 1.5 times ULN
- Women of childbearing potential agree to use effective contraception during treatment and for 3 months after
You will not qualify if you...
- Intracranial metastases requiring local treatment or meningeal carcinomatosis
- Major surgery within 4 weeks prior to first dose
- Radiotherapy, chemotherapy, other clinical trial drugs, or anti-tumor treatment within 5 half-lives or 3 weeks before first dose
- Previous treatment with ATR inhibitors or other DNA damage response inhibitors except PARP inhibitors
- History of another primary malignancy except certain in situ carcinomas, locally excised non-melanoma skin cancer, or disease-free for 2+ years without treatment
- Treatment with strong CYP3A4, CYP2C8, or P-gp inhibitors or inducers within 14 days prior to first dose
- Unresolved adverse events greater than CTCAE grade 1 from prior anti-tumor therapy except alopecia, pigmentation, lymphopenia
- Inability to swallow tablets or gastrointestinal conditions affecting absorption
- Severe or uncontrolled diseases including poorly controlled blood pressure, significant heart conditions, active infections, viral hepatitis, immunodeficiency, poorly controlled diabetes, or liver disease
- Uncontrolled pleural, pericardial, or peritoneal effusions
- Significant bleeding symptoms or bleeding tendency within 3 months
- Known hypersensitivity to study drug or components
- Any other acute or chronic medical, psychiatric, or lab abnormalities increasing risk or interfering with study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
L
Lingying Wu, PHD
CONTACT
G
Guangwen Yuan, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
11
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