This is an open, multicenter Phase I study to evaluate the safety and tolerability of HRS-6208 in patients with advanced solid tumors.
Eligibility
Sex
ALL
Min age
18 Years
Max age
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.
Primary outcome measure(s)
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.
Trial sites (2)
Facility
City
Region
Status
Nanjing Drum Tower Hospital
Nanjing
Jiangsu
Recruiting
West China Hospital of Sichuan University
Chengdu
Sichuan
Recruiting
More Shandong Suncadia Medicine Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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