Evaluating SPH4336 alone or with Cadonilimab for 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 study is testing whether a new drug called SPH4336, alone or with another drug called Cadonilimab, can help people with advanced solid tumors who can't have surgery or other local treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 63 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd (Industry-sponsored)
• Drugs / interventions: Cadonilimab
• Locations: 16 sites (Fuzhou, Fujian and 15 other locations)
• Trial ID: NCT05944224 on ClinicalTrials.gov

What this trial studies

This is a randomized, open-label Phase Ib/IIa study designed to assess the efficacy and safety of SPH4336, both as a monotherapy and in combination with Cadonilimab, in patients suffering from selected advanced solid tumors. Participants will be enrolled based on specific eligibility criteria, including having measurable lesions and meeting organ function requirements. The study aims to provide insights into the potential benefits of these treatments for patients who cannot undergo radical surgery or other local treatments.

Who should consider this trial

Good fit: Ideal candidates include patients with advanced solid tumors who have a life expectancy of at least three months and cannot be treated with radical surgery.

Not a fit: Patients with solid tumors that can be effectively treated with radical surgery or other local treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer new treatment options for patients with advanced solid tumors who currently have limited therapeutic alternatives.

How similar studies have performed: While there is ongoing research in this area, the specific combination of SPH4336 and Cadonilimab is novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Fuzhou, Fujian and 15 other locations

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

Study contacts

• Study coordinator: Haiyan Hu

Conditions Advanced Solid Tumors