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

Last updated: January 12, 2026
Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasms

Treatment

SPH4336

Cadonilimab

Clinical Study ID

NCT05944224
SPH4336-201
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 Welldifferentiated/dedifferentiated liposarcoma) who cannot be treated by radicalsurgery/other local treatment.

  4. According to RECIST v1.1, participants in the dose expansion phase must have atleast one measurable lesion.

  5. The laboratory test results meet the organ function requirements before starting thestudy treatment.

  6. Prior to the start of the study treatment, the peripheral nerve toxicity of previousanti-tumor drug treatment had returned to ≤ grade 2, and other reversible toxicreactions had returned to ≤ grade 1, but hair loss/pigmentation and other effectswere assessed by the investigator as beneficial to the subjects receiving the studytreatment. The toxicity of the risk is not subject to this limitation.

  7. Subjects agree to use effective contraception from the time they sign the informedconsent to the last time they use the study drug.

Exclusion

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 adverseeffects of surgery.

  3. Had a history of other malignancies before starting the study.

  4. History of myocardial infarction, unstable angina pectoris, severe arrhythmia, andsymptomatic 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 thestart of the study and assessed by the investigators could not be included in thestudy.

  6. Previous history of organ transplantation.

  7. Before starting the study, HBsAg positive patients with HBV DNA > 500IU/ mL or 2500copies /mL or the lower limit of the study center detection, or HCV antibodypositive patients with HCV RNA positive, or known HIV-infected patients, or knownactive tuberculosis.

  8. Accompanied by any other serious, progressive, or uncontrolled disease.

  9. Subjects with a known history of immune-related adverse events that the investigatordetermined could not be included.

  10. History of severe allergic disease, history of severe drug allergy, or known allergyto 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 theinvestigator.

Study Design

Total Participants: 63
Treatment Group(s): 2
Primary Treatment: SPH4336
Phase: 1/2
Study Start date:
October 17, 2023
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Fujian Cancer Hospital

    Fuzhou, Fujian
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou 1810821, Fujian 1811017
    China

    Active - Recruiting

  • The First Affiliated Hospital,Sun Yat-sen University

    Guangzhou, Guangdong
    China

    Site Not Available

  • The First Affiliated Hospital,Sun Yat-sen University

    Guangzhou 1809858, Guangdong 1809935
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou 1784658, He'nan
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan
    China

    Site Not Available

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei
    China

    Site Not Available

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan 1791247, Hubei 1806949
    China

    Active - Recruiting

  • Xiangya Hospital Central South University

    Changsha, Hunan
    China

    Site Not Available

  • The Central Hospital of Yongzhou

    Yongzhou, Hunan
    China

    Site Not Available

  • Xiangya Hospital Central South University

    Changsha 1815577, Hunan 1806691
    China

    Active - Recruiting

  • The Central Hospital of Yongzhou

    Yongzhou 1786217, Hunan 1806691
    China

    Active - Recruiting

  • Liaoning Cancer Hospital & Institute

    Shenzhen, Liaoning 2036115
    China

    Active - Recruiting

  • Xijing Hospital

    Xi'an, Shanxi
    China

    Site Not Available

  • Xijing Hospital

    Xi’an 11474004, Shanxi 1795912
    China

    Active - Recruiting

  • West China Hospital,Sichuan University

    Chengdu, Sichuan
    China

    Site Not Available

  • West China Hospital,Sichuan University

    Chengdu 1815286, Sichuan 1794299
    China

    Active - Recruiting

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang
    China

    Active - Recruiting

  • Zhejiang cancer Hospital

    Hangzhou, Zhejiang
    China

    Site Not Available

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou 1808926, Zhejiang 1784764
    China

    Active - Recruiting

  • Zhejiang cancer Hospital

    Hangzhou 1808926, Zhejiang 1784764
    China

    Active - Recruiting

  • Peking Union Medical College Hospital

    Beijing,
    China

    Active - Recruiting

  • Peking University People's Hospital

    Beijing,
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing 1816670,
    China

    Active - Recruiting

  • Peking University People's Hospital

    Beijing 1816670,
    China

    Active - Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai,
    China

    Site Not Available

  • Shanghai Sixth People's Hospital

    Shanghai,
    China

    Active - Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai 1796236,
    China

    Active - Recruiting

  • Shanghai Sixth People's Hospital

    Shanghai 1796236,
    China

    Active - Recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin,
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin 1792947,
    China

    Active - Recruiting

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