A Study to Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors.
NCT ID: NCT05944224
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
63 participants
INTERVENTIONAL
2023-10-17
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SPH4336
SPH4336
SPH4336 Tablets ：Orally, 400mg once a day ; 28 days/cycle
Cadonilimab
Cadonilimab
Intravenous infusion, 6mg/Kg,28 days/cycle
SPH4336+ Cadonilimab
SPH4336
SPH4336 Tablets ：Orally, 400mg once a day ; 28 days/cycle
Cadonilimab
Intravenous infusion, 6mg/Kg,28 days/cycle
Interventions
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SPH4336
SPH4336 Tablets ：Orally, 400mg once a day ; 28 days/cycle
Cadonilimab
Intravenous infusion, 6mg/Kg,28 days/cycle
Eligibility Criteria
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Inclusion Criteria
2. Expected survival ≥3 months.
3. Patients with advanced solid tumors (including advanced Well differentiated/dedifferentiated liposarcoma) who cannot be treated by radical surgery/other local treatment.
4. According to RECIST v1.1, participants in the dose expansion phase must have at least one measurable lesion.
5. The laboratory test results meet the organ function requirements before starting the study treatment.
6. Prior to the start of the study treatment, the peripheral nerve toxicity of previous anti-tumor drug treatment had returned to ≤ grade 2, and other reversible toxic reactions had returned to ≤ grade 1, but hair loss/pigmentation and other effects were assessed by the investigator as beneficial to the subjects receiving the study treatment. The toxicity of the risk is not subject to this limitation.
7. Subjects agree to use effective contraception from the time they sign the informed consent to the last time they use the study drug.
Exclusion Criteria
2. Had undergone surgery prior to treatment and hasn't yet recovered from adverse effects of surgery.
3. Had a history of other malignancies before starting the study.
4. History of myocardial infarction, unstable angina pectoris, severe arrhythmia, and symptomatic congestive heart failure before the start of study treatment; NYHA Class ≥II; QTcF≥ 470 ms; LVEF≤ 50%.
5. Diseases affecting drug administration or gastrointestinal absorption before the start of the study and assessed by the investigators could not be included in the study.
6. Previous history of organ transplantation.
7. Before starting the study, HBsAg positive patients with HBV DNA \> 500IU/ mL or 2500 copies /mL or the lower limit of the study center detection, or HCV antibody positive patients with HCV RNA positive, or known HIV-infected patients, or known active tuberculosis.
8. Accompanied by any other serious, progressive, or uncontrolled disease.
9. Subjects with a known history of immune-related adverse events that the investigator determined could not be included.
10. History of severe allergic disease, history of severe drug allergy, or known allergy to any component of the investigational product.
11. Women who are pregnant or breastfeeding.
12. Any other reason for which patients are ineligible for the study as assessed by the investigator.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Pharmaceuticals Holding Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Fujian Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital，Sun Yat-sen University
Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, He'nan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Xiangya Hospital Central South University
Changsha, Hunan, China
The Central Hospital of Yongzhou
Yongzhou, Hunan, China
Liaoning Cancer Hospital & Institute
Shenzhen, Liaoning, China
Xijing Hospital
Xi’an, Shanxi, China
West China Hospital，Sichuan University
Chengdu, Sichuan, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang cancer Hospital
Hangzhou, Zhejiang, China
Peking Union Medical College Hospital
Beijing, , China
Peking University People's Hospital
Beijing, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Shanghai Sixth People's Hospital
Shanghai, , China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, , China
Countries
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Central Contacts
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Facility Contacts
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Yu Chen
Role: primary
Jingnan Shen
Role: primary
Peng Zhang
Role: primary
Jing Chen
Role: primary
Bin Li
Role: primary
Sijuan Ding
Role: primary
Xiaojing Zhang
Role: primary
Hongmei Zhang
Role: primary
Yu Jiang
Role: primary
Zhaoming Ye
Role: primary
Meiyu Fang
Role: primary
Mei Guan
Role: primary
Xin Sun
Role: primary
Xiaodong Tang
Role: backup
Biqiang Zheng
Role: primary
Jilong Yang
Role: primary
Other Identifiers
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SPH4336-201
Identifier Type: -
Identifier Source: org_study_id
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