Actively Recruiting
Phase I Study of WJ47156 Monotherarpy and in Combination With Other Therapy in Advanced Solid Tumors
Led by Shanghai Junshi Bioscience Co., Ltd. · Updated on 2025-02-21
93
Participants Needed
1
Research Sites
131 weeks
Total Duration
On this page
Sponsors
S
Shanghai Junshi Bioscience Co., Ltd.
Lead Sponsor
S
Sponsor GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is an open-label, dose-escalation and expansion, Phase I clinical study to evaluate the safety, tolerability, PK characteristics and preliminary antitumor activity of WJ47156 monotherapy and in combination with toripalimab in patients with advanced malignant solid tumors. The study consists of two parts, including monotherapy (Part 1) and combination therapy (Part 2).
CONDITIONS
Official Title
Phase I Study of WJ47156 Monotherarpy and in Combination With Other Therapy in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years inclusive at time of consent
- Histologically or cytologically confirmed advanced malignant solid tumors
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Life expectancy of at least 12 weeks
- At least one measurable lesion per RECIST 1.1
- Adequate organ function
- Patients of childbearing potential agree to use effective contraception during the study and for 6 months after last dose
- Voluntary participation with signed informed consent and good compliance
You will not qualify if you...
- Presence of central nervous system metastasis
- Pleural, peritoneal, or pericardial effusion with symptoms or need for repeated treatment
- Inability to swallow tablets or intestinal obstruction affecting drug absorption
- For combination therapy: tumor encasement of major vessel or necrosis increasing hemorrhage risk
- Active autoimmune diseases requiring systemic treatment within 2 years prior to first dose (some exceptions allowed)
- Prior treatment with anti-PD-1/L1 therapy
- History of interstitial lung disease or active pneumonia at screening
- Gastrointestinal perforation, fistula, abscess, or recent ulcerative disease
- Serious, unhealed wounds, active ulcers, or untreated fractures
- Recent history or risk of gastrointestinal bleeding
- Clinically significant bleeding within one month prior to first dose
- History of bleeding disorders or severe coagulation dysfunction
- Severe drug-related adverse events causing permanent discontinuation of bevacizumab or similar
- Use of antiplatelet or anticoagulant therapy within 14 days prior to first dose
- Uncontrolled hypertension or severe cardiovascular disease
- Serious infection within 28 days or active infection requiring treatment within 2 weeks prior to first dose
- Active tuberculosis or hepatitis B or C infection
- History of immunodeficiency or organ transplantation
- History of other primary malignant tumors except certain treated skin cancers
- Unresolved toxicity from prior antitumor therapy above specified levels
- Recent chemotherapy, immunotherapy, anti-tumor therapy, or surgery within specified timeframes
- Recent use of systemic corticosteroids or immunosuppressants above allowed doses
- Recent live or attenuated vaccine use or planned vaccination during study
- Any other serious physical or mental conditions or lab abnormalities increasing study risk or affecting compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
N
NIannian Wang, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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