Clinical trial NCT05394818: The Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-27
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

Brief 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.


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;
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.

Primary outcomes:
measure: Maximum tolerated dose (MTD) or maximum administered dose (MAD)
timeFrame: From Day 1 to 90 days after last dose
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: PK parameter: Tmax of SHR-A2009
timeFrame: approximately 6 months
measure: PK parameter: Cmax of SHR-A2009
timeFrame: approximately 6 months
measure: PK parameter: AUC0-t of SHR-A2009
timeFrame: approximately 6 months
measure: PK parameter: 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: Beijing
country: China
facility: Chinese PLA General Hospital-Department of Medical Oncology
state: Beijing
Study officials:
References: