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NCT Number: NCT05394818

The Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid Tumors

This study is an open-label, phase I clinical trial of SHR-A2009 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 Tumor

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chinese PLA General Hospital-Department of Medical Oncology

Beijing, Beijing Municipality, 100039, China

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;
  • 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-A2009

Drug

The total dosage of SHR-A2009 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: From Day 1 to 90 days after last dose

    Incidence and category of dose limiting toxicities (DLTs) during the first cycle of SHR-A2009 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, 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-A2009 by way of adverse events (CTCAE v5.0).

Secondary outcomes

  1. PK parameter: Tmax of SHR-A2009

    Time frame: approximately 6 months

    Time to maximum concentration of SHR-A2009

  2. PK parameter: Cmax of SHR-A2009

    Time frame: approximately 6 months

    Maximum concentration of SHR-A2009

  3. PK parameter: AUC0-t of SHR-A2009

    Time frame: approximately 6 months

    area under the concentration-time curve from time 0 to the last measurable concentration time point of SHR-A2009

  4. PK parameter: AUC0-∞ of SHR-A2009

    Time frame: approximately 6 months

    area under the concentration-time curve from time 0 to infinity of SHR-A2009

  5. Immunogenicity of SHR-A2009

    Time frame: approximately 9 months

    Anti-SHR-A2009 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

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals 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-A2009 for Injection in Patients With Advanced Solid Tumors

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 27, 2022
Registry last updated
Dec 27, 2024

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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