A Phase 1/2 interventional study of SHR-8203 Injection in Solid Tumors, sponsored by Beijing Suncadia Pharmaceuticals Co., Ltd. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Beijing Suncadia Pharmaceuticals Co., Ltd (part of Jiangsu HengRui Medicine Co., Ltd.) · Phase 1/2, Interventional, and Treatment
This trial is a multicenter, open-label Phase I/II clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and efficacy of SHR-8203 injection in participants with advanced solid tumors.
Beijing Suncadia Pharmaceuticals Co., Ltd is the lead sponsor of 25 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: SHR-8203 Injection
SHR-8203 Injection Dose 1/ Dose 2/ Dose 3/ Dose 4
The number of subjects with dose-limiting toxicity (DLT)
Time frame: From first dose of study treatment until the end of Cycle 1（up to 21 days）
Incidence and severity of AEs
Time frame: From the first visit to the end of the safety follow-up period (1 year)
Maximum Tolerated Dose
Time frame: During the DLT observation period, the dose level at which the estimated toxicity probability was closest to the target toxicity probability (i.e., 0.3)（up to 21 days）
Determination of Recommended Phase II dose (RP2D)
Time frame: After dose optimization, sufficient safety, tolerability, PK and preliminary efficacy results were obtained, and the dose selected for the subsequent indication expansion stage was confirmed by SRC discussion (1 year).
Objective Response Rate (ORR)
Time frame: From time of first dose of SHR-8203 until the date of objective disease progression or death (1 year)
Duration of Response (DoR)
Time frame: From time of first dose of objective disease progression until the date of objective disease progression or death (1 year)
Disease Control Rate (DCR)
Time frame: From time of first dose of SHR-8203 until the date of objective disease progression or death (1 year)
Progression free Survival (PFS)
Progression-free survival is defined as the time from the start of treatment until the date of objective disease progression or death.
Time frame: From time of first dose of objective disease progression until the date of objective disease progression or death (1 year)
Overall Survival (OS)
The time until death due to any cause.
Time frame: From time of first dose of objective disease progression until the date of death (2 years)
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Beijing Suncadia Pharmaceuticals Co., Ltd →