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NCT Number: NCT06764628

A Study of SHR-4375 in Subjects With Solid Tumors

This is an open-label, three-part study to evaluate the safety and efficacy of SHR-4375 for injection in subjects with solid tumors.

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Key information

Conditions

Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Xianjun Yu

CONTACT

[email protected]

021-64175590

Xianjun Yu

PRINCIPAL_INVESTIGATOR

Xiaohua Wu

CONTACT

[email protected]

021-64175590 ext. 81000

Xiaohua Wu

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

  • Symptomatic, untreated or active central nervous system metastases.
  • 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-4375

Drug

SHR-4375 injection

Primary outcomes

  1. Adverse events (AEs)

    Time frame: From Day 1 to 90 days after last dose.

  2. Dose limiting toxicity (DLT)

    Time frame: From Day 1 to 12 months.

  3. Maximal tolerable dose (MTD)

    Time frame: From Day 1 to 12 months.

  4. Recommended phase 2 dose (RP2D)

    Time frame: From Day 1 to 12 months.

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yuanchao Wang

CONTACT

[email protected]

0518-82342973

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 8, 2025
Registry last updated
Jan 22, 2025

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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