Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06907628

A Trial of SHR-3792 Injection in Patients With Advanced Solid Tumors

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SHR-3792 injection monotherapy for patients with advanced solid tumors, and to explore the reasonable dosage of SHR-3792 injection monotherapy for patients with advanced solid tumors.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shandong First Medical University Affiliated Cancer Hospital

Jinan, Shandong, 250117, China

Location status: Recruiting

Location contact

Jinming Yu

CONTACT

[email protected]

+86-0531-67626073

Jinming Yu

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with ability to understand and voluntarily agree to participate by giving written informed consent form for the study.
  • Patients with unresectable recurrent or metastatic solid tumors.
  • There is at least one lesion that could be measured.
  • An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
  • Adequate organ functions as defined.
  • Life expectancy ≥ 3 months.

Exclusion criteria

  • Patients with known active central nervous system (CNS) metastases.
  • Subjects with other malignancy in five years before the first dose.
  • Patients with tumor-related pain that cannot be controlled as determined.
  • Patients with serious cardiovascular and cerebrovascular diseases.
  • Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion.
  • Patients with severe infections.
  • History of immunodeficiency.
  • History of autoimmune diseases.
  • Active infection.
  • Pregnant or nursing women.
  • Known history of serious allergic reactions to the investigational product or its main ingredients.

Treatment and study plan

SHR-3792 Injection

Drug

SHR-3792 injection.

Primary outcomes

  1. Maximum tolerated dose (MTD)

    Time frame: From the first dose of study medication up to 21 days.

  2. Recommended phase Ⅱ dose (RP2D)

    Time frame: From the first dose of study medication up to 21 days.

  3. Incidence of dose limited toxicity (DLT)

    Time frame: From the first dose of study medication up to 21 days.

  4. Adverse events (AEs)

    Time frame: Up to 24 weeks.

  5. Serious adverse events (SAEs)

    Time frame: Up to 24 weeks.

Secondary outcomes

  1. Objective response rate (ORR)

    Time frame: Up to 6 months.

Study contacts

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

Fangfang Peng

CONTACT

[email protected]

+86-0518-81220121

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

A Phase Ⅰ, Open Label, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-3792 in Patients With Advanced Solid Tumors

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 2, 2025
Registry last updated
Apr 25, 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.

Published trials that share one or more normalized conditions with this study.