Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05114759

A Phase I Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid Tumors

This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-A2009 for injection in patients with advanced solid tumors.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Advanced Solid Tumors

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chongqing Cancer Hospital, Chongqicun, Chongqi, 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 (patients with only non-target lesions are allowed to be enrolled in dose escalation stage);
  • 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 symptomatic 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

In dose Escalation:

SHR-A2009 will be administered intravenously. Six dose levels are preset.

In dose Expansion:

2 to 3 dose cohorts will be selected for dose expansion stage.

In indication Expansion:

Indications will be selected to evaluate preliminary efficacy.

Primary outcomes

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

    Time frame: From Day 1 to Day 21

    Incidence and category of dose limiting toxicities (DLTs) during the first 21-day 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. Tmax of SHR-A2009

    Time frame: approximately 6 months

    Time to maximum concentration of SHR-A2009

  2. Cmax of SHR-A2009

    Time frame: approximately 6 months

    Maximum concentration of SHR-A2009

  3. 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. 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

A Phase I, Open-Label, Multicenter 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
2026
Study completion
2026
First posted
Nov 10, 2021
Registry last updated
Jul 16, 2026

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.

Related clinical trials

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