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NCT Number: NCT07123129

A Trial of SHR-7782 for Treatment of Advanced Malignant Tumors

The main objective of this study is to evaluate the effectiveness and safety of SHR-7782 for participants with advanced malignant cancer.

Recruiting

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participate in the study voluntarily, sign the informed consent form.
  • Subjects were able to provide primary or metastatic cancer samples.
  • At least one measurable lesion (RECIST version 1.1).
  • ECOG 0~1.
  • With adequate organ functions.
  • Expected survival time ≥ 12 weeks.

Exclusion criteria

  • With untreated brain metastasis or active central nervous system tumor metastases.
  • Imaging shows that the tumor invades large blood vessels or has unclear boundaries with blood vessels.
  • Patients with other malignant tumors in the past or at the same time.
  • Patients with clinical symptoms, uncontrolled, or moderate or above pleural effusion, pericardial effusion, or peritoneal effusion.
  • Patients with a history of interstitial pneumonia or interstitial lung disease or non-infectious pneumonia requiring steroid treatment.
  • With poorly controlled or severe cardiovascular disease.
  • Bleeding events of NCI-CTCAE v5.0 grade ≥ 2 occurred within 1 month before the first medication.
  • Subjects who had a serious infection within 1 month before the first medication.
  • History of immunodeficiency.
  • Known allergy to any component of the SHR-7782 product.
  • According to the researcher's judgment, there are other factors that may affect the research results or cause the research to be terminated midway.

Treatment and study plan

SHR-7782 Injection

Drug

SHR-7782 injection.

Primary outcomes

  1. Dose Limited Toxicity (DLT)

    Time frame: Up to 21 days.

  2. Maximum Tolerated Dose (MTD)

    Time frame: Up to 6 months.

  3. Recommended Phase II Dose (RP2D)

    Time frame: Up to 21 days.

Secondary outcomes

  1. Objective Response Rate (ORR) assessed by the investigator according to RECIST 1.1 criteria

    Time frame: Up to approximately 24 months.

  2. Duration of Response (DoR) assessed by the investigator according to RECIST 1.1 criteria

    Time frame: Up to approximately 24 months.

  3. Disease Control Rate (DCR) assessed by the investigator according to RECIST 1.1 criteria

    Time frame: Up to approximately 24 months.

  4. Progression Free Survival (PFS) assessed by the investigator according to RECIST 1.1 criteria

    Time frame: Up to approximately 24 months.

  5. Overall Survival (OS)

    Time frame: Up to approximately 24 months.

Study contacts

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

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-7782 Injection in the Treatment of Advanced Malignant Cancer

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 14, 2025
Registry last updated
Jan 30, 2026

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

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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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