About this trial
This is an open-label, multi-center, multi-cohort, phase Ib/II clinical trial, divided into 8 cohorts according to tumor types. Cohorts 1-4 are SYHA1813 combined with different regimens, including safety run-in stage and cohort expansion stage. Cohorts 5-8 are SYHA1813 monotherapy and only include the expansion cohorts. The primary objective was to evaluate the safety and efficacy of SYHA1813 single agent or in combination with different regimens in unresectable locally advanced or metastatic solid tumors.
Eligibility criteria
Qualifiers
Aged >= 18 years;
There is at least one measurable lesion in the baseline period (RECIST1.1);
ECOG PS of 0-1;
The expected survival time is >=3 months;
Disqualifiers
Patients who are known or suspected to be allergic to the test drug or its components;
Excluding the disease studied in this trial, there are other primary malignant tumors that have progressed or require treatment within the past 3 years prior to screening (except for effectively controlled skin basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer or cured breast carcinoma in situ);
The toxicity of previous anti-tumor treatments has not recovered (≤grode 1), except for hair loss and other adverse reactions judged by the investigator that do not affect the safety of the study medication;
Active leptomeningeal disease or CNS metastases that are not well controlled;
Trial design
Treatments tested in this trial
- SYHA1813
- SG001
- HB1801
- Carboplatin
- Cisplatin
- Paclitaxel
- Etoposide
- Everolimus
- Regorafenib