Advanced Solid Tumors
Conditions
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.
Interventions
DRUGSHR-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.
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single arm study of SHR-A2009
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-∞ of SHR-A2009 | approximately 6 months | area under the concentration-time curve from time 0 to infinity of SHR-A2009 |
| Immunogenicity of SHR-A2009 | approximately 9 months | Anti-SHR-A2009 antibody (ADA) |
| Overall response rate (ORR) | approximately within 36 months | Evaluated using RECIST 1.1 |
| Tmax of SHR-A2009 | approximately 6 months | Time to maximum concentration of SHR-A2009 |
| Disease control rate (DCR) | approximately within 36 months | Evaluated using RECIST 1.1 |
| Progression-free survival (PFS) | approximately within 36 months | Evaluated using RECIST 1.1 |
| Duration of response (DoR) | approximately within 36 months | Evaluated using RECIST 1.1 |
| Cmax of SHR-A2009 | approximately 6 months | Maximum concentration of SHR-A2009 |
| AUC0-t of SHR-A2009 | approximately 6 months | area under the concentration-time curve from time 0 to the last measurable concentration time point of SHR-A2009 |
Countries
China, Japan, South Korea
Contacts
Primary ContactWei Shi, MD, PhD
Outcome results
None listed