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A Phase I/II Study of WJB001 Combination Therapy on Safety and Efficacy for Advanced Solid Tumors
Led by Wigen Biomedicine Technology (Shanghai) Co., Ltd. · Updated on 2026-03-27
86
Participants Needed
10
Research Sites
233 weeks
Total Duration
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AI-Summary
What this Trial Is About
This is a phase I/II study to preliminarily explore of the safety, tolerability, pharmacokinetics, and efficacy of WJB001 combination therapy, consisting of three stages: Dose escalation (Phase Ia), dose extension (Phase Ib), and efficacy extension (Phase II). The preliminary plan includes seven combination therapy regimens, namely Arm A: WJB001+taxanes (A1: WJB001+paclitaxel, A2: WJB001+albumin paclitaxel); Arm B: WJB001+platinum (B1: WJB001+carboplatin, B2: WJB001+nedaplatin); Arm C: WJB001+paclitaxel+carboplatin; Arm D: WJB001+PARP inhibitor; Arm E: WJB001+VEGF inhibitor; Arm F:WJB001+JS207/JS001（F1：WJB001+JS207，F2：WJB001+JS001）；Arm G：WJB001+JS207/JS001+paclitaxel+carboplatin（G1: WJB001+JS207 +paclitaxel+carboplatin；G2：WJB001+JS001+paclitaxel+carboplatin）.
CONDITIONS
Official Title
A Phase I/II Study of WJB001 Combination Therapy on Safety and Efficacy for Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must voluntarily consent and sign an informed consent form.
- Age 18 years or older with no gender restriction and BMI of at least 18.5.
- Diagnosed with advanced solid tumors confirmed by pathology or cytology.
- Provide tumor tissue samples for biomarker detection including CCNE1 overexpression confirmed by central lab.
- Have failed, are intolerant to, or lack standard treatment options (for Dose Escalation phase).
- For specific cancers (platinum-sensitive or resistant ovarian, fallopian tube, peritoneal, or uterine serous carcinoma).
- Have at least one target lesion meeting RECIST v1.1 criteria, not biopsied within 2 weeks.
- ECOG performance status of 0 or 1.
- Expected survival of at least 12 weeks.
- Adequate blood and organ function based on recent lab tests without recent blood transfusions or stimulating factors.
- Resolved acute toxic reactions from prior treatments to baseline or grade 1 (except hair loss or pigmentation).
- Use effective contraceptive methods during the study.
You will not qualify if you...
- Pregnant or breastfeeding women.
- Known allergies or contraindications to study drug components.
- History of substance or alcohol abuse exceeding 28 units per week.
- Prior or current treatment with Wee1, CDK2, PKMYT1, PARG, or ATR inhibitors.
- Recent cytotoxic chemotherapy, traditional Chinese medicine, other antitumor drugs within 14 days, or investigational/macromolecular drugs within 28 days before first study dose.
- Use of moderate or strong CYP3A or P-gp inhibitors/inducers within 5 half-lives or 14 days before first dose.
- Organ or stem cell transplant, major surgery or severe trauma within 4 weeks before first dose, minor surgery within 7 days.
- Recent radiation therapy within 21 days (except minimal bone marrow volume cases).
- Poorly controlled pleural effusion, ascites, or pericardial effusion requiring recent drainage.
- History of severe adverse events leading to discontinuation of anti-PD-(L)1 or anti-VEGF therapies (specific arms).
- Recent live or live-attenuated vaccine within 28 days before first dose.
- Recent antiplatelet or anticoagulant therapy restrictions.
- Primary platinum-refractory disease.
- Active gastrointestinal issues affecting drug absorption or metabolism.
- History of severe eye disease not improved to grade 1.
- Active brain metastases not stabilized.
- Carcinomatous meningitis, spinal cord compression, hepatic encephalopathy.
- Severe or uncontrolled hypertension.
- Certain cardiac conditions or abnormal ECG findings.
- Significant bleeding or coagulation disorders within recent months.
- Active HBV, HCV, or HIV infection.
- History of other primary solid tumors with exceptions.
- Severe active infections.
- Active autoimmune diseases requiring systemic treatment within 2 years.
- History of interstitial lung disease or non-infectious pneumonia requiring steroids.
- TP53 wild-type phenotype by genetic testing or immunohistochemistry.
- Other factors interfering with participation or study results as deemed by investigator.
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
2
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350000
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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
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5
Sun Yat-sen Hospital, Sun Yat-sen University
Guangzhou, Gunagdong, China, 510000
Actively Recruiting
6
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430023
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7
Hunan Cancer Hospital
Changsha, Hunan, China, 410000
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8
Liaoning Cancer Hospital
Shenyang, Liaoning, China, 110000
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9
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China, 110000
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10
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
Y
Yirong Zhao, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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