A Study to Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors.
- Registration Number
- NCT05944224
- Lead Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 63
- Subjects voluntarily participate in this study and sign informed consent.
- Expected survival ≥3 months.
- Patients with advanced solid tumors (including advanced Well differentiated/dedifferentiated liposarcoma) who cannot be treated by radical surgery/other local treatment.
- According to RECIST v1.1, participants in the dose expansion phase must have at least one measurable lesion.
- The laboratory test results meet the organ function requirements before starting the study treatment.
- 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.
- Subjects agree to use effective contraception from the time they sign the informed consent to the last time they use the study drug.
- 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 adverse effects of surgery.
- Had a history of other malignancies before starting the study.
- 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%.
- 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.
- Previous history of organ transplantation.
- 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.
- Accompanied by any other serious, progressive, or uncontrolled disease.
- Subjects with a known history of immune-related adverse events that the investigator determined could not be included.
- History of severe allergic disease, history of severe drug allergy, or known allergy to 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 the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SPH4336 SPH4336 - SPH4336+ Cadonilimab SPH4336 - Cadonilimab Cadonilimab - SPH4336+ Cadonilimab Cadonilimab -
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) Approximately 2 years From the start date of study treatment to the date of progression disease or death , whichever occurred first.
- Secondary Outcome Measures
Name Time Method Objective response rate (ORR) Approximately 2 years Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
Cmax Approximately 2 years PK (Pharmacokinetics) parameters.
progression-free rate（PFR） Approximately 2 years Proportion of subjects who were alive and free of disease progression from the first use of the investigational drug to 12 weeks.
Disease control rate (DCR) Approximately 2 years DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease.
Duration of remission (DOR) Approximately 2 years DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response to the date of disease progression per RECIST v1.1 or death from any cause.
Overall Survival (OS) Approximately 8 years Determination of the overall survival times of all patients.
Incidence of Adverse event Approximately 2 years Safety and tolerability
Tmax Approximately 2 years PK (Pharmacokinetics) parameters.
Trial Locations
- Locations (16)
The First Affiliated Hospital，Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, China
Tianjin Medical University Cancer Institute & Hospital
🇨🇳Tianjin, China
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
The Central Hospital of Yongzhou
🇨🇳Yongzhou, Hunan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Liaoning Cancer Hospital & Institute
🇨🇳Shenzhen, Liaoning, China
Xijing Hospital
🇨🇳Xi'an, Shanxi, China
The Second Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Peking Union Medical College Hospital
🇨🇳Beijing, China
Zhejiang cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Shanghai Sixth People's Hospital
🇨🇳Shanghai, China
West China Hospital，Sichuan University
🇨🇳Chengdu, Sichuan, China
Peking University People's Hospital
🇨🇳Beijing, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China