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NCT Number: NCT07830199

A Clinical Study of SHR-4595 Injection in Patients With Advanced Solid Tumors to Evaluate Safety, Tolerability and Pharmacokinetics

The study is being conducted to evaluate the safety and tolerability of SHR-4595 for injection in participants with advanced solid tumors, and to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended dose for Phase II clinical studies (RP2D) of SHR-4595.

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Key information

Conditions

Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cancer Hospital of Dalian University of Technology (Liaoning Cancer Hospital & Institute), Shenyang, Liaoning, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

A subject must satisfy all of the following criteria to be considered for inclusion in the study.

  • The subjects voluntarily joined the study and signed the ICF.
  • Measurable disease, as defined by RECIST v1.1.
  • The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1.
  • Life expectancy ≥ 12 weeks.
  • 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.

  • Symptomatic, untreated or active central nervous system metastases.
  • Have uncontrolled or severe cardiovascular disease Have clinical symptoms or disease of the heart that are not well controlled.
  • With any active autoimmune disease or history of autoimmune disease.
  • Patients with active hepatitis B or hepatitis C.
  • Severe infections prior to initiation of study treatment.

Treatment and study plan

SHR-4595 for Injection

Drug

SHR-4595 for injection, in different doses.

Primary outcomes

  1. Adverse events (AEs)

    Time frame: From Day 1 to 40 days after last dose.

    Safety endpoints.

  2. Dose-limiting toxicity (DLT)

    Time frame: From Day 1 to 12 months.

    Safety endpoints.

  3. Maximum Tolerated Dose (MTD)

    Time frame: From Day 1 to 12 months.

    Safety endpoints.

  4. Recommended Phase 2 Dose (RP2D)

    Time frame: From Day 1 to 12 months.

    Safety endpoints.

Secondary outcomes

  1. Progression free survival (PFS)

    Time frame: From Day 1 to 12 months.

  2. Objective response rate (ORR)

    Time frame: From Day 1 to 12 months.

  3. Disease control rate (DCR)

    Time frame: From Day 1 to 12 months.

  4. Duration of response (DOR)

    Time frame: From Day 1 to 12 months.

  5. Overall survival (OS)

    Time frame: From Day 1 to 12 months.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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