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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: SPH4336; Drug: Cadonilimab

• Study Type: Interventional
• Enrollment (Estimated): 63
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Haiyan Hu; Phone Number: 0086-020-87343535; Email: xuri1104@163.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University People's Hospital
    • Contact: Xin Sun
    • Contact: Xiaodong Tang
  • Beijing, China
    • Recruiting
    • Peking Union Medical College Hospital
    • Contact: Mei Guan
  • Shanghai, China
    • Recruiting
    • Fudan University Shanghai Cancer Center
    • Contact: Biqiang Zheng
  • Shanghai, China
    • Recruiting
    • Shanghai Sixth People's Hospital
    • Contact: Haiyan Hu; Phone Number: 0086-020-87343535; Email: xuri1104@163.com
  • Tianjin, China
    • Recruiting
    • Tianjin Medical University Cancer Institute & Hospital
    • Contact: Jilong Yang
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • Fujian Cancer Hospital
      • Contact: Yu Chen
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital,Sun Yat-sen University
      • Contact: Jingnan Shen
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • Henan Cancer Hospital
      • Contact: Peng Zhang
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology
      • Contact: Jing Chen
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Xiangya Hospital Central South University
      • Contact: Bin Li
    • Yongzhou, Hunan, China
      • Recruiting
      • The Central Hospital of Yongzhou
      • Contact: Sijuan Ding
  • Liaoning
    • Shenzhen, Liaoning, China
      • Recruiting
      • Liaoning Cancer Hospital & Institute
      • Contact: Xiaojing Zhang
  • Shanxi
    • Xi'an, Shanxi, China
      • Recruiting
      • Xijing Hospital
      • Contact: Hongmei Zhang
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • West China Hospital，Sichuan University
      • Contact: Yu Jiang
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: Meiyu Fang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • The Second Affiliated Hospital Zhejiang University School of Medicine
      • Contact: Zhaoming Ye

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SPH4336	Drug: SPH4336; SPH4336 Tablets ：Orally, 400mg once a day ; 28 days/cycle
Experimental: Cadonilimab	Drug: Cadonilimab; Intravenous infusion, 6mg/Kg,28 days/cycle
Experimental: SPH4336+ Cadonilimab	Drug: SPH4336; SPH4336 Tablets ：Orally, 400mg once a day ; 28 days/cycle; Drug: Cadonilimab; Intravenous infusion, 6mg/Kg,28 days/cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Determination of the overall survival times of all patients.	Approximately 8 years
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
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
Cmax	PK (Pharmacokinetics) parameters.	Approximately 2 years
Tmax	PK (Pharmacokinetics) parameters.	Approximately 2 years
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
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
Incidence of Adverse event	Safety and tolerability	Approximately 2 years

Collaborators and Investigators

• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SPH4336-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No