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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Maximum tolerated dose (MTD) or maximum administered dose (MAD). — From Day 1 to Day 21 Incidence and category of dose limiting toxicities (DLTs) during the first 21-day cycle of SHR-A2009 treatment.
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.
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).
Trial sites (16)
Facility
City
Region
Status
Chongqing Cancer Hospital
Chongqicun
Chongqi
Fujian Provincial Cancer Hospital
Fuzhou
Fujian
Guangdong Provincial People's Hospital
Guangzhou
Guangdong
Hunan Cancer Hospital
Changsha
Hunan
The Second Affiliated Hospital of Nanchang University
Nanchang
Jiangxi
The First Hospital of JiLin University
Changchun
Jlin
Shandong Cancer Hospital&Institute
Jinan
Shandong
The Second Affiliated Hospital of Air Force Military University Tangdu Hospital
Xi’an
Shanxi
Sichuan Cancer Hospital & Institute
Chengdu
Sichuan
West China Hospital,Sichuan University
Chengdu
Sichuan
First Affiliated Hospital of Kunming Medical University
Kunming
Yunnan
National Cancer Center Hospital East
Chiba
Chiba
National Cancer Center Hospital
Tokyo
Tokyo
Seoul National University Hospital
Seoul
Seoul
Asan Medical Center
Seoul
Seoul
Samsung Medical Center
Seoul
Seoul
More Suzhou Suncadia Biopharmaceuticals Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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