SHR-4610 injection for advanced solid tumors

An Open-label, Multicenter Phase I/II Clinical Study of SHR-4610 Injection in Patients With Advanced Solid Tumors to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy

This trial will test SHR-4610 injection to see if it helps adults (18–75) with unresectable or metastatic solid tumors that have not responded to standard treatments.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 258 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Shengdi Pharmaceutical Co., Ltd (industry)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07231211 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter Phase 1/2 trial is organized into a dose exploration stage (dose escalation and dose extension) followed by an efficacy extension stage. Participants receive SHR-4610 by injection while investigators monitor safety and tolerability and identify a recommended dose. The dose-escalation phase determines safety and dose-limiting toxicities, and extension cohorts evaluate preliminary anti-tumor activity at selected doses. Eligible patients have histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors, measurable disease per RECIST v1.1, ECOG 0–1, and adequate organ function.

Who should consider this trial

Good fit: Adults aged 18–75 with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors that are relapsed/refractory to standard therapies or lack standard treatments, with measurable disease, ECOG 0–1, and adequate organ function are the intended participants.

Not a fit: Patients with active central nervous system or meningeal metastases, uncontrolled significant cardiovascular disease, moderate/severe symptomatic effusions or ascites, active hepatitis B or C, or recent systemic anticancer therapy may not benefit or may be ineligible.

Why it matters

Potential benefit: If successful, SHR-4610 could become a new treatment option that shrinks tumors or controls disease in some patients with advanced, treatment-resistant solid tumors.

How similar studies have performed: Early-phase dose-escalation programs for novel oncology injections have sometimes led to later effective therapies in specific tumor types, but SHR-4610's clinical effectiveness has not yet been established.

Eligibility criteria

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.

Where this trial is running

Hangzhou, Zhejiang

• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Yunpeng Jin

Conditions: Solid Tumors