Solid Tumors
Conditions
Brief summary
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.
Interventions
DRUGSHR-8203 Injection
SHR-8203 Injection Dose 1/ Dose 2/ Dose 3/ Dose 4
Sponsors
Beijing Suncadia Pharmaceuticals Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 and 75 years old, gender not limited; 2. Be willing to participate and abide by the requirements of the research protocol, and be willing to cooperate with the follow-up. 3. Participants with advanced or metastatic solid tumors confirmed by histological or cytological pathology who have failed standard treatment (disease progression or toxic intolerance) or have no effective standard treatment; 4. Able to provide sufficient fresh or archived tumor tissue specimens for the third-party central laboratory designated by the sponsor. 5. Have at least one measurable lesion as per RECIST v1.1; 6. ECOG PS score: 0-1; 7. Good organ function level.
Exclusion criteria
1. Imaging studies show that the tumor invades major blood vessels or has an unclear boundary with blood vessels, and researchers determine that there is a risk of massive hemorrhage; 2. Suffering from hypertension and unable to achieve good control through antihypertensive drug treatment; 3. Pleural effusion, pericardial effusion or peritoneal effusion accompanied by clinical symptoms, poorly controlled, or moderate to severe; 4. Major arterial or venous thrombosis events occurred within 6 months before the first administration of medication; 5. Participants who have experienced severe infections within one month prior to the first medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of subjects with dose-limiting toxicity (DLT) | From first dose of study treatment until the end of Cycle 1（up to 21 days） |
| Incidence and severity of AEs | From the first visit to the end of the safety follow-up period (1 year) |
| Maximum Tolerated Dose | 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) | 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) | From time of first dose of SHR-8203 until the date of objective disease progression or death (1 year) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DoR) | From time of first dose of objective disease progression until the date of objective disease progression or death (1 year) | — |
| Disease Control Rate (DCR) | From time of first dose of SHR-8203 until the date of objective disease progression or death (1 year) | — |
| Progression free Survival (PFS) | From time of first dose of objective disease progression until the date of objective disease progression or death (1 year) | Progression-free survival is defined as the time from the start of treatment until the date of objective disease progression or death. |
| Overall Survival (OS) | From time of first dose of objective disease progression until the date of death (2 years) | The time until death due to any cause. |
Countries
China
Contacts
CONTACTFang fang Peng, Doctoral degree
CONTACTXin Xu, Bachelor's degree
Outcome results
None listed