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

Advanced Solid Tumors Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05114759
• Other study ID #: SHR-A2009-I-101
• Status: Recruiting
• Phase: Phase 1
• Start date: January 4, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: October 2021
• Source: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
• Contact: Wei Shi, MD, PhD
• Phone: +86 021-61053363
• Email: wei.shi[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 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 (patients with only non-target lesions are allowed to be enrolled in dose escalation stage);

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 symptomatic 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 Tumors
• Neoplasms

Intervention

Drug:
• SHR-A2009
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.

Locations

Country	Name	City	State
China	The First Hospital of JiLin University	Changchun	Jlin
China	Hunan Cancer Hospital	Changsha	Hunan
China	Sichuan Cancer Hospital & Institute	Chengdu	Sichuan
China	West China Hospital,Sichuan University	Chengdu	Sichuan
China	Chongqing Cancer Hospital	Chongqi	Chongqi
China	Fujian Provincial Cancer Hospital	Fuzhou	Fujian
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	Shandong Cancer Hospital&Institute	Jinan	Shandong
China	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	The Second Affiliated Hospital of Air Force Military University Tangdu Hospital	Xi'an	Shanxi
Japan	National Cancer Center Hospital East	Chiba
Japan	National Cancer Center Hospital	Tokyo
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Countries where clinical trial is conducted

China,  Japan,  Korea, Republic of, 

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 21-day cycle of SHR-A2009 treatment.	From Day 1 to Day 21
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	Tmax of SHR-A2009	Time to maximum concentration of SHR-A2009	approximately 6 months
Secondary	Cmax of SHR-A2009	Maximum concentration of SHR-A2009	approximately 6 months
Secondary	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	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