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

Phase 1

Completed

• Conditions: Advanced Solid Tumor
• Interventions: Drug: SHR-A2009

• Registration Number: NCT05394818
• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-24
• Study First Submitted QC: 2022-05-24
• Study First Posted: 2022-05-27
• Study Start: 2022-07-21
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-25
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHR-A2009	SHR-A2009	-

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD) or maximum administered dose (MAD)	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.
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) ([CTCAE] v5.0)	From Day 1 to 90 days after last dose	Assess safety and tolerability of SHR-A2009 by way of adverse events (CTCAE v5.0).
Recommended Phase 2 dose (RP2D)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chinese PLA General Hospital-Department of Medical Oncology; 🇨🇳 Beijing, Beijing, China