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NCT Number: NCT05944224

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Fujian Cancer Hospital, Fuzhou, Fujian, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

SPH4336

Drug

SPH4336 Tablets :Orally, 400mg once a day ; 28 days/cycle

cadonilimab

Drug

Intravenous infusion, 6mg/Kg,28 days/cycle

Primary outcomes

  1. Progression-free survival (PFS)

    Time frame: Approximately 2 years

    From the start date of study treatment to the date of progression disease or death , whichever occurred first.

Secondary outcomes

  1. Objective response rate (ORR)

    Time frame: Approximately 2 years

    Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.

  2. progression-free rate(PFR)

    Time frame: Approximately 2 years

    Proportion of subjects who were alive and free of disease progression from the first use of the investigational drug to 12 weeks.

  3. Cmax

    Time frame: Approximately 2 years

    PK (Pharmacokinetics) parameters.

  4. Tmax

    Time frame: Approximately 2 years

    PK (Pharmacokinetics) parameters.

  5. Disease control rate (DCR)

    Time frame: Approximately 2 years

    DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease.

  6. Duration of remission (DOR)

    Time frame: Approximately 2 years

    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.

  7. Overall Survival (OS)

    Time frame: Approximately 8 years

    Determination of the overall survival times of all patients.

  8. Incidence of Adverse event

    Time frame: Approximately 2 years

    Safety and tolerability

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Industry

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 13, 2023
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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