Solid Tumors
Conditions
Brief summary
This study is an open, multicenter Phase I/II clinical trial, divided into two stages: dose exploration (including dose escalation and dose extension) and efficacy extension.
Interventions
DRUGSHR-4610 Injection
SHR-4610 injection
SHR-A1811 for injection
Sponsors
Shanghai Shengdi Pharmaceutical Co., Ltd
Study design
Allocation
NON_RANDOMIZED
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. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form; 2. Age range: 18-75 years old, both male and female are welcome; 3. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment; 4. Have at least one measurable tumor lesion per RECIST v1.1; 5. ECOG performance status of 0-1; 6. Life expectancy ≥ 12 weeks; 7. Adequate bone marrow and organ function.
Exclusion criteria
1. Patients with active central nervous system metastases or meningeal metastases; 2. Systemic antitumor therapy was received 4 weeks before the start of the study; 3. Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or higher pleural effusion or pericardial effusion; 4. Have poorly controlled or severe cardiovascular disease; 5. Subjects with active hepatitis B or active hepatitis C; 6. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Dose-Limiting Toxicity (DLT) | Post-dose at day 1 to the end of treatment visit, about 1 year. |
| The Maximum Tolerated Dose (MTD) | Post-dose at day 1 to the end of treatment visit, about 1 year. |
| Recommended dosage for Phase II (RP2D) | Post-dose at day 1 to the end of treatment visit, about 1 year. |
| Incidence and severity of adverse events (AEs) | Up to 90 days after the last administration. |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) | From the first administration to the end of treatment visit, about 1 year. |
| Duration of relief (DOR) | From the first administration to the end of treatment visit, about 1 year. |
| Disease Control Rate (DCR) | From the first administration to the end of treatment visit, about 1 year. |
| Time to Response (TTR) | From the first administration to the end of treatment visit, about 1 year. |
| Progression-free survival (PFS) | From the first administration to the end of treatment visit, about 1 year. |
| Time to the maximum plasma concentration (Tmax) | From Day 1 pre-dose to 30 days after the last administration. |
| Maximum concentration of SHR-4610 (Cmax) | From Day 1 pre-dose to 30 days after the last administration. |
| SHR-4610 serum trough concentration (Ctrough) | From Day 1 pre-dose to 30 days after the last administration. |
| Area under the concentration versus time curve of SHR-4610 from time zero to time t (AUC0-t) | From Day 1 pre-dose to 30 days after the last administration. |
Countries
China
Contacts
CONTACTYunpeng Jin
CONTACTYuting Wang
Outcome results
None listed