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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Pharmaceuticals Holding Co., Ltd

About this trial

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

Qualifiers

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.

Disqualifiers

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%.

Trial design

Treatments tested in this trial

  • SPH4336
  • Cadonilimab

Treatment groups

63 Participants
are divided into 3 treatment groups