Clinical Trials in China / NCT07231211
Recruiting
Phase 1/2
A Study of SHR-4610 Injection in Patients With Advanced Solid Tumors
NCT07231211 · tracked via the Priya Life Science China tracker
Condition(s) studied
Solid Tumors
Investigational drug(s) / intervention(s)
SHR-4610 Injection: SHR-4610 injection
SHR-A1811 for injection: SHR-A1811 for injection
Study 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.
Eligibility
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.
Primary outcome measure(s)
- 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | Recruiting |
More Shanghai Shengdi Pharmaceutical Co., Ltd trials in China
Other trials for the same condition
A Study of ADRX-0706 in Select Advanced Solid Tumors
Active, not recruiting
Official registry record
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.
View NCT07231211 on ClinicalTrials.gov ↗ ← All trials in China