SHR-4595 Injection in Advanced Solid Tumors: Safety, Tolerability, and Dosing in Phase 1
Official title: An Open-label, Multicenter Phase I Clinical Study of SHR-4595 Injection in Patients With Advanced Solid Tumors to Evaluate Safety, Tolerability and Pharmacokinetics
Run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · NCT07830199 · Data updated 2026-11-12
This early-phase trial tests SHR-4595 injections to see if they are safe and tolerable for adults with advanced solid tumors who have exhausted standard treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 208 (estimated) |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. Industry-sponsored |
| Locations | 2 sites (Shenyang, Liaoning and 1 other locations) |
| Status | Recruiting |
| Started | October 20, 2026 |
| Main results expected | December 2029 |
| Study ends | December 2030 |
| Registry record updated | November 2, 2026 |
| Trial ID | NCT07830199 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with advanced, measurable solid tumors who have failed or declined standard therapy, and who are ECOG 0-1 with expected survival ≥ 12 weeks.
✕Probably not a fit
Patients with active CNS metastases, uncontrolled cardiovascular disease, active autoimmune disease, or active hepatitis B/C may not experience benefit and may be excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 interventional study evaluates SHR-4595 for injection in patients with advanced solid tumors to determine safety, tolerability, and pharmacokinetics. The trial will identify dose-limiting toxicities (DLT), the maximum tolerated dose (MTD), and the recommended dose for Phase II (RP2D). Eligible participants must have measurable disease, good performance status (ECOG 0-1), and a life expectancy of at least 12 weeks, having failed or refused standard therapy. Exclusion criteria include active CNS metastases, uncontrolled cardiovascular disease, active autoimmune disease, and active hepatitis B or C. The lead sponsor is Suzhou Suncadia Biopharmaceuticals, with participating sites at two cancer hospitals in China.
Why it matters
Potential benefit: If successful, participants may benefit from the potential therapeutic effects of SHR-4595 and contribute to determining a dose for future studies.
How similar studies have gone: As a first-in-class Phase 1 study, prior evidence for SHR-4595 is not established; its success would depend on tolerability and PK data from this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: A subject must satisfy all of the following criteria to be considered for inclusion in the study. 1. The subjects voluntarily joined the study and signed the ICF. 2. Measurable disease, as defined by RECIST v1.1. 3. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1. 4. Life expectancy ≥ 12 weeks. 5. Subjects with cytologically or histologically confirmed advanced solid tumors who have failed or are intolerant to standard therapy, have no standard therapy, or refuse standard therapy. Exclusion Criteria: A subject who meets any of the following criteria will be excluded from study entry. 1. Symptomatic, untreated or active central nervous system metastases. 2. Have uncontrolled or severe cardiovascular disease Have clinical symptoms or disease of the heart that are not well controlled. 3. With any active autoimmune disease or history of autoimmune disease. 4. Patients with active hepatitis B or hepatitis C. 5. Severe infections prior to initiation of study treatment.
Where it's running
-
Cancer Hospital of Dalian University of Technology (Liaoning Cancer Hospital & Institute)
Shenyang, Liaoning, China Recruiting -
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China Recruiting
Study contacts
- Study coordinator: Hongxia Han
- Email: hongxia.han@hengrui.com
- Phone: +86-0518-82342973
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.