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NCT Number: NCT05836948

The Clinical Study of SHR-9839 for Injection in Patients With Advanced Solid Tumors

This study is an open-label, phase I clinical trial of SHR-9839 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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Zhejiang Tumor Hospital

Hangzhou, Zhejiang, 310006, China

Location status: Recruiting

Location contact

Xiangdong Cheng, Doctor

CONTACT

[email protected]

+86-13968032995

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;
  • 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.

Exclusion criteria

  • Patients with active central nervous system metastases or meningeal metastases;
  • Received anti-tumor treatment such as chemotherapy, biotherapy, targeted therapy, immunotherapy, radical radiotherapy, or other unlisted clinical research drugs or treatments within 4 weeks prior to the first use of the study drug;
  • History of serious cardiovascular and cerebrovascular diseases;
  • Subjects who received>30Gy of radiation therapy within 4 weeks before the first medication, and those who received ≤ 30Gy of palliative radiation therapy within 7 days before the first medication;
  • Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.

Treatment and study plan

SHR-9839

Drug

Weekly fixed dose injection of SHR-9839

Primary outcomes

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

    Time frame: On the first day of each week,4 weeks is a treatment cycle

    Incidence and category of dose limiting toxicities (DLTs) during the first 4 week cycle of SHR-9839 treatment

  2. Recommended Phase 2 dose (RP2D)

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

    RP2D will be determined on the basis of evaluation on MTD/MAD, PK, PD, efficacy data in dose escalation and dose expansion stages.

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

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

    Assess safety and tolerability of SHR-9839 by way of adverse events (CTCAE v5.0).

Secondary outcomes

  1. PK parameter: Tmax of SHR-9839

    Time frame: approximately 10 months

    Time to maximum concentration of SHR-9839

  2. PK parameter: Cmax of SHR-9839

    Time frame: approximately 10 months

    Maximum concentration of SHR-9839

  3. PK parameter: AUC0-t of SHR-9839

    Time frame: Approximately 10 months

    Area under the concentration-time curve from time 0 to the last measurable concentration time point of SHR-9839

  4. PK parameter: AUC0-∞ of SHR-9839

    Time frame: Approximately 10 months

    Area under the concentration-time curve from time 0 to infinity of SHR-9839

  5. Immunogenicity of SHR-9839

    Time frame: Approximately 12 months

    Anti-SHR-9839 antibody (ADA)

  6. Overall response rate (ORR)

    Time frame: Approximately within 36 months

    Evaluated using RECIST 1.1

  7. Duration of response (DoR)

    Time frame: Approximately within 36 months

    Evaluated using RECIST 1.1

  8. Disease control rate (DCR)

    Time frame: Approximately within 36 months

    Evaluated using RECIST 1.1

  9. Progression-free survival (PFS)

    Time frame: Approximately within 36 months

    Evaluated using RECIST 1.1

Study contacts

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

Jin Wang, COD

CONTACT

[email protected]

+86 021-61053363

Rongfu Mao, MD

CONTACT

[email protected]

+86 021-61053363

Sponsors and collaborators

Lead sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

An Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-9839 for Injection in Patients With Advanced Solid Tumors

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 1, 2023
Registry last updated
Aug 11, 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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