Actively Recruiting
SON-DP in Participants With Relapsed/Refractory Intolerant to Standard of Care Therapies for Advanced/Metastatic Solid Tumors
Led by Qurgen Inc. · Updated on 2025-09-03
96
Participants Needed
11
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase I Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of SON-DP in Subjects with Advanced Solid Tumors
CONDITIONS
Official Title
SON-DP in Participants With Relapsed/Refractory Intolerant to Standard of Care Therapies for Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 to 75 years (inclusive).
- Participants with histologically confirmed solid tumors for Phase Ia.
- Participants with advanced primary liver cancer or advanced primary gastric cancer for Phase Ib.
- At least one measurable lesion by RECIST v1.1, excluding lesions affected by recent local treatments.
- ECOG performance status of 0 or 1.
- Able to understand and willing to sign informed consent.
- Expected lifespan greater than 3 months as assessed by investigator.
- Candidates for and able to manage central venous access line.
- Participants with treated, stable brain metastases off steroids for at least 2 weeks.
- Willing to undergo tumor biopsies as required.
- Adequate liver and kidney function as defined by specific lab criteria.
- Primary liver cancer participants classified as Child-Pugh class A or B with score 7 and no hepatic encephalopathy.
- Adequate bone marrow function with defined blood counts and no recent transfusions or growth factor support.
- Acceptable coagulation test results with specific limits.
- Toxicity from previous treatments returned to baseline or grade 1 or less with some exceptions.
- Female participants agree not to breastfeed during and for 90 days after study.
- Fertile participants agree to use reliable contraception during and for 90 days after study.
You will not qualify if you...
- Pregnant or breastfeeding women.
- Participation in another investigational study within 2 weeks or 5 half-lives before starting treatment.
- Active or untreated CNS metastases requiring therapy or increasing steroid doses.
- Significant or uncontrolled heart disease including heart failure, low ejection fraction, uncontrolled hypertension, arrhythmias, recent heart attack, or unstable angina.
- Uncontrolled hypertension or recent hypertensive crisis.
- Stroke or significant brain hemorrhage within 6 months.
- Severe pulmonary diseases including recent pulmonary embolism, severe asthma, COPD, restrictive lung disease, or pneumonia.
- Active HIV infection or active chronic hepatitis B or C; active syphilis.
- Other primary cancers except certain cured or indolent malignancies.
- Symptomatic pleural, pericardial effusion, or ascites requiring repeated drainage.
- Recent anticancer therapy or radiation within specified time frames.
- Chronic systemic steroid or immunosuppressive therapy above allowed doses.
- Use of live vaccines within 4 weeks prior to and during treatment.
- Active neurological symptoms or recent stroke except stable chronic conditions.
- Use of medications incompatible with urea or requiring special caution.
- Diseases affecting thirst recognition center.
- Active infection requiring IV antibiotic or antiviral treatment within 14 days.
- Major surgery within 4 weeks except minor procedures.
- History of organ or stem cell transplant within 5 years.
- Any condition preventing safe participation or compliance.
- Allergy to study drug or its components.
- History of severe allergic reaction to protein products.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 11 locations
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Not Yet Recruiting
2
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
3
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China, 102200
Actively Recruiting
4
The First Hospital of Lanzhou University
Lanzhou, Gansu, China, 730000
Actively Recruiting
5
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
6
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
7
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Actively Recruiting
8
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi, China, 710061
Actively Recruiting
9
Introduction to Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)
Jinan, Shandong, China, 250117
Actively Recruiting
10
ZhongShan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
11
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
J
Jianjun Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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