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

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumors

In brief

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.

Key facts

Study ID

NCT05944224

Run by

Shanghai Pharmaceuticals Holding Co., Ltd

People needed

63

Starts

2023-10-17

Expected to finish

2026-12-31

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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