A Study to Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors.

Advanced Solid Tumors Clinical Trial

Official title:

A Randomized, Open-label, Phase Ib/IIa Clinical Study to Evaluate the Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors, Including Advanced Well Differentiated/Dedifferentiated Liposarcoma.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05944224
• Other study ID #: SPH4336-201
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 17, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2023
• Source: Shanghai Pharmaceuticals Holding Co., Ltd
• Contact: Haiyan Hu
• Phone: 0086-020-87343535
• Email: xuri1104[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 63
• Est. completion date: December 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• SPH4336
SPH4336 Tablets :Orally, 400mg once a day ; 28 days/cycle
• Cadonilimab
Intravenous infusion, 6mg/Kg,28 days/cycle

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing
China	Peking University People's Hospital	Beijing
China	Xiangya Hospital Central South University	Changsha	Hunan
China	West China Hospital,Sichuan University	Chengdu	Sichuan
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	The First Affiliated Hospital,Sun Yat-sen University	Guangzhou	Guangdong
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhejiang cancer Hospital	Hangzhou	Zhejiang
China	Fudan University Shanghai Cancer Center	Shanghai
China	Shanghai Sixth People's Hospital	Shanghai
China	Liaoning Cancer Hospital & Institute	Shenzhen	Liaoning
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin
China	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei
China	Xijing Hospital	Xi'an	Shanxi
China	The Central Hospital of Yongzhou	Yongzhou	Hunan
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pharmaceuticals Holding Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)	From the start date of study treatment to the date of progression disease or death , whichever occurred first.	Approximately 2 years
Secondary	Objective response rate (ORR)	Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.	Approximately 2 years
Secondary	progression-free rate(PFR)	Proportion of subjects who were alive and free of disease progression from the first use of the investigational drug to 12 weeks.	Approximately 2 years
Secondary	Cmax	PK (Pharmacokinetics) parameters.	Approximately 2 years
Secondary	Tmax	PK (Pharmacokinetics) parameters.	Approximately 2 years
Secondary	Disease control rate (DCR)	DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease.	Approximately 2 years
Secondary	Duration of remission (DOR)	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.	Approximately 2 years
Secondary	Overall Survival (OS)	Determination of the overall survival times of all patients.	Approximately 8 years
Secondary	Incidence of Adverse event	Safety and tolerability	Approximately 2 years