A IB/II Phase Clinical Study on the Safety, Tolerability, and Efficacy of SHR-9839(sc) in Combination Anti-tumor Therapy in Patients With Solid Tumors

ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

About this trial

This study is an open-label, multi-center Phase IB/II clinical trial of SHR-9839(sc) combined with anti-tumor therapy in patients with advanced solid tumors, aimed at evaluating the safety, tolerability, and efficacy of SHR-9839(sc) in combination with anti-tumor therapy in patients with advanced solid tumors.

Eligibility criteria

Qualifiers

Able to provide informed consent, has signed the IRB/EC-approved informed consent form with the date indicated, and is willing and able to comply with treatment plan visits, examinations, and other procedural requirements;

Age 18-70 years (inclusive) at the time of signing the informed consent form, no gender restriction;

ECOG performance status of 0 or 1;

Expected survival ≥12 weeks;

Disqualifiers

Patients with active central nervous system (CNS) metastases or leptomeningeal metastases (including a history of such);

Patients with other malignancies within 3 years before the first dose, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, locally resected prostate cancer, ductal carcinoma in situ post-surgery, or papillary thyroid carcinoma post-surgery (hormonal therapy for non-metastatic prostate or breast cancer is allowed);

Patients deemed by the investigator to have uncontrolled tumor-related pain. Subjects requiring analgesic treatment must have a stable analgesic regimen before entering the study; symptomatic lesions suitable for palliative radiotherapy should be treated prior to study entry;

Patients with severe cardiovascular or cerebrovascular disease;

Trial design

Treatments tested in this trial

  • SHR-9839(sc) For Injection

Treatment groups

70 Participants
are divided into 2 treatment groups