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

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

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.

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: SHR-A2009

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100039
      • Chinese PLA General Hospital-Department of Medical Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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;
2. Have at least one measurable tumor lesion per RECIST v1.1;
3. ECOG performance status of 0-1;
4. Life expectancy ≥ 12 weeks;
5. Adequate bone marrow and organ function.
6. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-A2009	Drug: SHR-A2009; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum tolerated dose (MTD) or maximum administered dose (MAD)	Incidence and category of dose limiting toxicities (DLTs) during the first cycle of SHR-A2009 treatment.	From Day 1 to 90 days after last dose
Recommended Phase 2 dose (RP2D)	RP2D will be determined on the basis of evaluation on MTD/MAD, PK, efficacy data in dose escalation and dose expansion stages.	From Day 1 to 90 days after last dose
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) ([CTCAE] v5.0)	Assess safety and tolerability of SHR-A2009 by way of adverse events (CTCAE v5.0).	From Day 1 to 90 days after last dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameter: Tmax of SHR-A2009	Time to maximum concentration of SHR-A2009	approximately 6 months
PK parameter: Cmax of SHR-A2009	Maximum concentration of SHR-A2009	approximately 6 months
PK parameter: AUC0-t of SHR-A2009	area under the concentration-time curve from time 0 to the last measurable concentration time point of SHR-A2009	approximately 6 months
PK parameter: AUC0-∞ of SHR-A2009	area under the concentration-time curve from time 0 to infinity of SHR-A2009	approximately 6 months
Immunogenicity of SHR-A2009	Anti-SHR-A2009 antibody (ADA)	approximately 9 months
Overall response rate (ORR)	Evaluated using RECIST 1.1	approximately within 36 months
Duration of response (DoR)	Evaluated using RECIST 1.1	approximately within 36 months
Disease control rate (DCR)	Evaluated using RECIST 1.1	approximately within 36 months
Progression-free survival (PFS)	Evaluated using RECIST 1.1	approximately within 36 months

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2022
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: May 24, 2022
• First Submitted That Met QC Criteria: May 24, 2022
• First Posted (Actual): May 27, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 25, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SHR-A2009-I-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No