Actively Recruiting
A Study to Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors.
Led by Shanghai Pharmaceuticals Holding Co., Ltd · Updated on 2026-01-13
63
Participants Needed
16
Research Sites
167 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized, Open-label, Phase Ib/IIa study to evaluate the efficacy and safety of SPH4336 monotherapy or in combination with Cadonilimab in the patients with selected advanced solid tumors.
CONDITIONS
Official Title
A Study to Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Expected survival of at least 3 months
- Have advanced solid tumors, including advanced well differentiated/dedifferentiated liposarcoma, not suitable for radical surgery or local treatment
- Have at least one measurable tumor lesion according to RECIST v1.1 for dose expansion phase
- Meet laboratory requirements for organ function before starting treatment
- Previous anti-tumor drug toxicities have returned to grade 2 or less for peripheral nerve toxicity and grade 1 or less for other reversible toxicities, except for hair loss or pigmentation
- Agree to use effective contraception from consent until last use of study drug
You will not qualify if you...
- Taking anti-tumor traditional Chinese medicines at the time of consent
- Not recovered from surgery adverse effects prior to treatment
- History of other malignancies before study start
- History of myocardial infarction, unstable angina, severe arrhythmia, symptomatic congestive heart failure (NYHA Class II or higher), QTcF ≥ 470 ms, or LVEF ≤ 50%
- Diseases affecting drug administration or gastrointestinal absorption preventing study inclusion
- Previous organ transplantation
- Positive for HBsAg with high HBV DNA levels, positive for HCV antibody with HCV RNA positive, known HIV infection, or active tuberculosis
- Other serious, progressive, or uncontrolled diseases
- Known immune-related adverse events precluding study participation
- History of severe allergic disease, severe drug allergy, or allergy to study drugs
- Pregnant or breastfeeding women
- Other investigator-assessed reasons for ineligibility
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Fujian Cancer Hospital
Fuzhou, Fujian, China
Actively Recruiting
2
The First Affiliated Hospital，Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
3
Henan Cancer Hospital
Zhengzhou, He'nan, China
Actively Recruiting
4
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
5
Xiangya Hospital Central South University
Changsha, Hunan, China
Actively Recruiting
6
The Central Hospital of Yongzhou
Yongzhou, Hunan, China
Actively Recruiting
7
Liaoning Cancer Hospital & Institute
Shenzhen, Liaoning, China
Actively Recruiting
8
Xijing Hospital
Xi’an, Shanxi, China
Actively Recruiting
9
West China Hospital，Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
10
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
11
Zhejiang cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
12
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
13
Peking University People's Hospital
Beijing, China
Actively Recruiting
14
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
15
Shanghai Sixth People's Hospital
Shanghai, China
Actively Recruiting
16
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
Actively Recruiting
Research Team
H
Haiyan Hu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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