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NCT Number: NCT06381050

The Clinical Study of SHR-7631 for Injection in Patients With Advanced Solid Tumors

This study is an open-label, phase I clinical trial of SHR-7631 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion.

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking University Cancer Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently;
  • Have at least one measurable tumor lesion per RECIST v1.1 (subject with only non-target tumor lesion will be permitted if he/she is planned to participant in dose escalation stage or with mCRPC);
  • ECOG performance status of 0-1;
  • Life expectancy ≥ 12 weeks;
  • Adequate bone marrow and organ function
  • Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
  • Age 18 to 75 years old (including both ends), gender is not limited;

Exclusion criteria

  • Patients with active central nervous system metastases or meningeal metastases;
  • Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;
  • Prior treatment with antibody-drug conjugate (ADC) consisting of topoisomerase I inhibitors;
  • History of serious cardiovascular and cerebrovascular diseases;
  • Severe infection within 4 weeks prior to the first dose;
  • Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.

Treatment and study plan

SHR-7631

Drug

The total dosage of SHR-7631 was calculated according to the weight weighing results of the subjects before each administration, and was administered by intravenous drip.

Primary outcomes

  1. Maximum tolerated dose (MTD) or maximum administered dose (MAD)

    Time frame: 12 months

  2. Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) (CTCAE v5.0)

    Time frame: 36 months

Secondary outcomes

  1. PK parameter: Tmax

    Time frame: 36 months

  2. PK parameter: Cmax

    Time frame: 36 months

  3. PK parameter: AUC0-t

    Time frame: 36 months

  4. PK parameter: AUC0-∞

    Time frame: 36 months

  5. PK parameter: t1/2

    Time frame: 36 months

  6. PK parameter: MRT (mean residence time)

    Time frame: 36 months

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

An Open-label, Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-7631 for Injection in Patients With Advanced Solid Tumors

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 24, 2024
Registry last updated
Jun 13, 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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