Solid Tumors
Conditions
Brief summary
This is an open, multicenter Phase I study to evaluate the safety and tolerability of HRS-6208 in patients with advanced solid tumors.
Interventions
DRUGHRS-6208
HRS-6208.
Sponsors
Shandong Suncadia Medicine 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. Patients with unresectable locally advanced or metastatic solid tumors confirmed by histology or cytology who have relapsed or progressed after standard treatment, or have no standard treatment options, or do not apply standard treatment at this stage; 2. Age 18\ 75 years old; 3. At least one measurable lesion per RECIST v1.1 criteria; 4. ECOG PS score: 0-1.
Exclusion criteria
1. History of other malignancies within the past 5 years, excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; 2. The adverse reactions of previous anti-tumor therapy have not recovered to NCI-CTCAE v5.0 grade evaluation ≤ 1; 3. He has severe cardiovascular and cerebrovascular diseases; 4. Severe infection within 4 weeks prior to the first dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events (AEs) | From Day 1 to 30 days after the last dose. |
| Maximum tolerated dose (MTD) | From Day 1 to 21 days after the first dose. |
| Dose limiting toxicity (DLT) | From Day 1 to 21 days after the first dose. |
| Recommended phase 2 dose (RP2D) | From Day 1 to 30 days after the last dose. |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) | From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months). |
| Overall Survival (OS) | From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months). |
| Duration of Response (DoR) | From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months). |
| Disease Control Rate (DCR) | From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months). |
| Progression free Survival (PFS) | From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months). |
Countries
China
Contacts
Primary ContactXin Xu
Backup ContactZhiye Chen
Outcome results
None listed