Trial Title:
A Study to Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors.
NCT ID:
NCT05944224
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SPH4336
Description:
SPH4336 Tablets ：Orally, 400mg once a day ; 28 days/cycle
Arm group label:
SPH4336
Arm group label:
SPH4336+ Cadonilimab
Intervention type:
Drug
Intervention name:
Cadonilimab
Description:
Intravenous infusion, 6mg/Kg,28 days/cycle
Arm group label:
Cadonilimab
Arm group label:
SPH4336+ Cadonilimab
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subjects voluntarily participate in this study and sign informed consent.
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:
1. Taking anti-tumor traditional Chinese medicines at the time of signing the ICF.
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu Chen
Facility:
Name:
The First Affiliated Hospital，Sun Yat-sen University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Jingnan Shen
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Peng Zhang
Facility:
Name:
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Jing Chen
Facility:
Name:
Xiangya Hospital Central South University
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Contact:
Last name:
Bin Li
Facility:
Name:
The Central Hospital of Yongzhou
Address:
City:
Yongzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Sijuan Ding
Facility:
Name:
Liaoning Cancer Hospital & Institute
Address:
City:
Shenzhen
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaojing Zhang
Facility:
Name:
Xijing Hospital
Address:
City:
Xi'an
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongmei Zhang
Facility:
Name:
West China Hospital，Sichuan University
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu Jiang
Facility:
Name:
The Second Affiliated Hospital Zhejiang University School of Medicine
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhaoming Ye
Facility:
Name:
Zhejiang cancer Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Meiyu Fang
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Mei Guan
Facility:
Name:
Peking University People's Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Xin Sun
Contact backup:
Last name:
Xiaodong Tang
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Biqiang Zheng
Facility:
Name:
Shanghai Sixth People's Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Haiyan Hu
Phone:
0086-020-87343535
Email:
xuri1104@163.com
Facility:
Name:
Tianjin Medical University Cancer Institute & Hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Jilong Yang
Start date:
October 17, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Shanghai Pharmaceuticals Holding Co., Ltd
Agency class:
Industry
Source:
Shanghai Pharmaceuticals Holding Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05944224
