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

Advanced Solid Tumor Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05394818
• Other study ID #: SHR-A2009-I-102
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 21, 2022
• Est. completion date: June 1, 2026

Study information

• Verified date: October 2023
• Source: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 19
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital-Department of Medical Oncology	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	PK parameter: Tmax of SHR-A2009	Time to maximum concentration of SHR-A2009	approximately 6 months
Secondary	PK parameter: Cmax of SHR-A2009	Maximum concentration of SHR-A2009	approximately 6 months
Secondary	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
Secondary	PK parameter: AUC0-8 of SHR-A2009	area under the concentration-time curve from time 0 to infinity of SHR-A2009	approximately 6 months
Secondary	Immunogenicity of SHR-A2009	Anti-SHR-A2009 antibody (ADA)	approximately 9 months
Secondary	Overall response rate (ORR)	Evaluated using RECIST 1.1	approximately within 36 months
Secondary	Duration of response (DoR)	Evaluated using RECIST 1.1	approximately within 36 months
Secondary	Disease control rate (DCR)	Evaluated using RECIST 1.1	approximately within 36 months
Secondary	Progression-free survival (PFS)	Evaluated using RECIST 1.1	approximately within 36 months