Clinical trial NCT05114759: A Phase I Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-11-10
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm study of SHR-A2009
Primary purpose: TREATMENT

Brief 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 criteria: 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 outcomes:
measure: Maximum tolerated dose (MTD) or maximum administered dose (MAD).
timeFrame: From Day 1 to Day 21
measure: Recommended Phase 2 dose (RP2D)
timeFrame: From Day 1 to 90 days after last dose
measure: Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) ([CTCAE] v5.0)
timeFrame: From Day 1 to 90 days after last dose
Secondary outcomes:
measure: Tmax of SHR-A2009
timeFrame: approximately 6 months
measure: Cmax of SHR-A2009
timeFrame: approximately 6 months
measure: AUC0-t of SHR-A2009
timeFrame: approximately 6 months
measure: AUC0-∞ of SHR-A2009
timeFrame: approximately 6 months
measure: Immunogenicity of SHR-A2009
timeFrame: approximately 9 months
measure: Overall response rate (ORR)
timeFrame: approximately within 36 months
measure: Duration of response (DoR)
timeFrame: approximately within 36 months
measure: Disease control rate (DCR)
timeFrame: approximately within 36 months
measure: Progression-free survival (PFS)
timeFrame: approximately within 36 months
Other outcomes:
Locations:
city: Chongqi
country: China
facility: Chongqing Cancer Hospital
state: Chongqi
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of JiLin University
state: Jlin
city: Jinan
country: China
facility: Shandong Cancer Hospital&Institute
state: Shandong
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Air Force Military University Tangdu Hospital
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Cancer Hospital & Institute
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital,Sichuan University
state: Sichuan
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Chiba
country: Japan
facility: National Cancer Center Hospital East
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: