Phase
Condition
Neoplasms
Treatment
SPH4336
Cadonilimab
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects voluntarily participate in this study and sign informed consent.
Expected survival ≥3 months.
Patients with advanced solid tumors (including advanced Welldifferentiated/dedifferentiated liposarcoma) who cannot be treated by radicalsurgery/other local treatment.
According to RECIST v1.1, participants in the dose expansion phase must have atleast one measurable lesion.
The laboratory test results meet the organ function requirements before starting thestudy treatment.
Prior to the start of the study treatment, the peripheral nerve toxicity of previousanti-tumor drug treatment had returned to ≤ grade 2, and other reversible toxicreactions had returned to ≤ grade 1, but hair loss/pigmentation and other effectswere assessed by the investigator as beneficial to the subjects receiving the studytreatment. The toxicity of the risk is not subject to this limitation.
Subjects agree to use effective contraception from the time they sign the informedconsent to the last time they use the study drug.
Exclusion
Exclusion Criteria:
Taking anti-tumor traditional Chinese medicines at the time of signing the ICF.
Had undergone surgery prior to treatment and hasn't yet recovered from adverseeffects of surgery.
Had a history of other malignancies before starting the study.
History of myocardial infarction, unstable angina pectoris, severe arrhythmia, andsymptomatic congestive heart failure before the start of study treatment; NYHA Class ≥II; QTcF≥ 470 ms; LVEF≤ 50%.
Diseases affecting drug administration or gastrointestinal absorption before thestart of the study and assessed by the investigators could not be included in thestudy.
Previous history of organ transplantation.
Before starting the study, HBsAg positive patients with HBV DNA > 500IU/ mL or 2500copies /mL or the lower limit of the study center detection, or HCV antibodypositive patients with HCV RNA positive, or known HIV-infected patients, or knownactive tuberculosis.
Accompanied by any other serious, progressive, or uncontrolled disease.
Subjects with a known history of immune-related adverse events that the investigatordetermined could not be included.
History of severe allergic disease, history of severe drug allergy, or known allergyto any component of the investigational product.
Women who are pregnant or breastfeeding.
Any other reason for which patients are ineligible for the study as assessed by theinvestigator.
Study Design
Connect with a study center
Fujian Cancer Hospital
Fuzhou, Fujian
ChinaSite Not Available
Fujian Cancer Hospital
Fuzhou 1810821, Fujian 1811017
ChinaActive - Recruiting
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong
ChinaSite Not Available
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou 1809858, Guangdong 1809935
ChinaActive - Recruiting
Henan Cancer Hospital
Zhengzhou 1784658, He'nan
ChinaActive - Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
ChinaSite Not Available
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei
ChinaSite Not Available
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan 1791247, Hubei 1806949
ChinaActive - Recruiting
Xiangya Hospital Central South University
Changsha, Hunan
ChinaSite Not Available
The Central Hospital of Yongzhou
Yongzhou, Hunan
ChinaSite Not Available
Xiangya Hospital Central South University
Changsha 1815577, Hunan 1806691
ChinaActive - Recruiting
The Central Hospital of Yongzhou
Yongzhou 1786217, Hunan 1806691
ChinaActive - Recruiting
Liaoning Cancer Hospital & Institute
Shenzhen, Liaoning 2036115
ChinaActive - Recruiting
Xijing Hospital
Xi'an, Shanxi
ChinaSite Not Available
Xijing Hospital
Xi’an 11474004, Shanxi 1795912
ChinaActive - Recruiting
West China Hospital,Sichuan University
Chengdu, Sichuan
ChinaSite Not Available
West China Hospital,Sichuan University
Chengdu 1815286, Sichuan 1794299
ChinaActive - Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
ChinaActive - Recruiting
Zhejiang cancer Hospital
Hangzhou, Zhejiang
ChinaSite Not Available
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou 1808926, Zhejiang 1784764
ChinaActive - Recruiting
Zhejiang cancer Hospital
Hangzhou 1808926, Zhejiang 1784764
ChinaActive - Recruiting
Peking Union Medical College Hospital
Beijing,
ChinaActive - Recruiting
Peking University People's Hospital
Beijing,
ChinaSite Not Available
Peking Union Medical College Hospital
Beijing 1816670,
ChinaActive - Recruiting
Peking University People's Hospital
Beijing 1816670,
ChinaActive - Recruiting
Fudan University Shanghai Cancer Center
Shanghai,
ChinaSite Not Available
Shanghai Sixth People's Hospital
Shanghai,
ChinaActive - Recruiting
Fudan University Shanghai Cancer Center
Shanghai 1796236,
ChinaActive - Recruiting
Shanghai Sixth People's Hospital
Shanghai 1796236,
ChinaActive - Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin,
ChinaSite Not Available
Tianjin Medical University Cancer Institute & Hospital
Tianjin 1792947,
ChinaActive - Recruiting

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