Actively Recruiting
A Study Explore WJB001 Capsules in Patients With Advanced Solid Tumors
Led by Wigen Biomedicine Technology (Shanghai) Co., Ltd. · Updated on 2026-04-01
210
Participants Needed
11
Research Sites
211 weeks
Total Duration
On this page
Sponsors
W
Wigen Biomedicine Technology (Shanghai) Co., Ltd.
Lead Sponsor
S
Sponsor GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase I/II study to evaluate the safety and tolerability, DLT(Dose limited toxicity), MTD(Maximum tolerated dose), and RP2D(Recommended phase II dose) of WJB001 capsules in patients with advanced solid tumors, including dose escalation phase, dose expansion phase and cohort expansion phase.The study includes screening, treatment and follow-up periods. In the Dose Escalation phase:Accelerated titration (the first two dose groups) and "BOIN" combination (the subsequent dose group) were used for dose escalation. In the Dose Expansion phase:Based on the previous data, 1 to 2 doses were selected to further evaluate the initial efficacy, safety, tolerability and pharmacokinetic characteristics to confirm RP2D. In the Efficacy Expansion phase:The preliminary plan of Efficacy expansion phase uses the Simon two-stage optimal method to expand 2 to 3 cohorts.
CONDITIONS
Official Title
A Study Explore WJB001 Capsules in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of informed consent
- Diagnosed with advanced malignant solid tumors confirmed by pathology or cytology
- Have failed standard treatment, have no standard treatment available, or are intolerant to standard treatment
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 1 or less
- Life expectancy of at least 12 weeks
- Adequate blood and organ function
- All acute toxic effects from previous cancer therapy or surgery resolved
- Fertile women must have a negative blood pregnancy test within 7 days before first dose and use effective contraception during treatment and for 3 months after
- Male participants with female partners of reproductive age must agree to use effective contraception during treatment and for 3 months after
- At least one measurable tumor lesion per RECIST v1.1 with no biopsy in 2 weeks before screening
- CCNE1 overexpression confirmed by central lab (dose expansion and efficacy expansion phases)
- For advanced uterine serous carcinoma, up to 2 lines of therapy allowed after first-line treatment
- For advanced high-grade serous ovarian, fallopian tube, or peritoneal cancer, up to 2 lines of therapy after platinum resistance allowed (dose expansion and efficacy expansion phases)
You will not qualify if you...
- Pregnant or lactating women
- Known allergies or contraindications to components of the study drug
- History of substance abuse
- History of alcohol abuse or consuming more than 28 units of alcohol per week
- Previous or current treatment with Wee1 inhibitors
- Received cytotoxic chemotherapy, anti-tumor traditional Chinese medicine, or other anti-tumor therapies within 4 weeks before first dose
- Received investigational or macromolecular anti-tumor drugs within 28 days before first dose or need to continue during the study
- Use of medium or strong CYP3A or P-gp inhibitors or inducers less than 5 half-lives or 14 days before first dose
- Known organ or stem cell transplant
- Major surgery or major trauma within 4 weeks before first dose (except needle biopsy)
- Radiation therapy within 21 days before first dose (except if ≤5% bone marrow irradiated)
- Active gastrointestinal conditions affecting drug absorption or metabolism
- History of severe ocular disease not recovered to grade 1 or less
- Active brain metastases unless stable for at least 4 weeks without corticosteroids
- Current cancer meningitis or spinal cord compression
- Severe or uncontrolled hypertension
- Clinically significant bleeding or bleeding tendency within 4 weeks before first dose
- Active hepatitis B or C infection
- Known HIV infection or seropositivity
- History of syphilis
- History of other primary solid tumors unless cured and inactive for 5 years with low recurrence risk
- Severe or clinically significant cardiac disease
- Severe active infections or other diseases affecting safety
- Other factors the investigator considers may interfere with participation
- TP53 wild-type phenotype detected by genetic or immunohistochemistry testing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
2
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350000
Actively Recruiting
3
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
4
Tumor Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, China, 530000
Actively Recruiting
5
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430023
Actively Recruiting
6
Hunan Cancer Hospital
Changsha, Hunan, China, 410000
Actively Recruiting
7
Fuxin People's Hospital (Fuxin Women and Children's Medical Center)
Fuxin, Liaoning, China, 123000
Not Yet Recruiting
8
Liaoning Cancer Hospital
Shenyang, Liaoning, China, 110000
Actively Recruiting
9
Shanxi Cancer Hospital
Taiyuan, Shanxi, China, 030000
Actively Recruiting
10
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi’an, Shanxi, China, 710061
Actively Recruiting
11
Henan Cancer Hospital
Henan, Zhenzhou, China, 450000
Actively Recruiting
Research Team
Y
Yirong Zhao, Medical Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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