A Study to Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patie… (NCT05944224) | Clinical Trial Compass
RecruitingPhase 1/2
A Study to Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors.
China63 participantsStarted 2023-10-17
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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.