Clinical trial Recruiting at 1 site Phase1; Phase2 Interventional Ages 18 and up

Evaluating SHR-4375 for patients with solid tumors

Official title: An Open-label, Single-arm, Multicenter Phase I/II Clinical Study of SHR-4375 Injection in Patients With Advanced Solid Tumors to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy

Run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · NCT06764628 · Data updated 2026-11-12

This study is testing a new treatment called SHR-4375 to see if it can help people with advanced solid tumors who haven't had success with other therapies.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment208 (estimated)
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.
Industry-sponsored
Locations1 site (Shanghai, Shanghai Municipality)
StatusRecruiting
StartedJanuary 9, 2025
Main results expectedMay 2027
Study endsMay 2027
Registry record updatedJanuary 22, 2025
Trial IDNCT06764628 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with advanced solid tumors who have not responded to or cannot tolerate standard treatments.

Probably not a fit

Patients with untreated central nervous system metastases or active autoimmune diseases may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, three-part study aims to assess the safety and efficacy of SHR-4375 in individuals diagnosed with solid tumors. Participants will receive SHR-4375 injections and will be monitored for their response to the treatment. The study includes patients who have advanced solid tumors and have either failed standard therapies or are intolerant to them. The research will follow strict eligibility criteria to ensure the safety and appropriateness of the participants.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited alternatives.

How similar studies have gone: While this approach is being explored, similar studies have shown promise in targeting solid tumors with novel therapies.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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:

1. Symptomatic, untreated or active central nervous system metastases.
2. With any active autoimmune disease or history of autoimmune disease.
3. Patients with active hepatitis B or hepatitis C.
4. Severe infections prior to initiation of study treatment.

Where it's running

  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai Municipality, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.