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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05114759
Other study ID # SHR-A2009-I-101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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