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This is a Phase 1 dose-escalation and expansion study that will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of SAIL66 in patients with CLDN6-positive locally advanced or metastatic solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Q3W Dose Escalation part | Experimental | Patients will receive SAIL66 as tri-weekly IV infusions at escalated doses. |
|
| Expansion part | Experimental | Patients will receive SAIL66 as a IV infusion at the recommended dose. |
|
| QW Dose Escalation part | Experimental | Patients will receive SAIL66 as a weekly IV infusion at escalated doses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAIL66 | Drug | SAIL66 as a IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events of SAIL66[safety and tolerability] | Incidence, nature, and severity of adverse events graded according to NCI Common Terminology CTCAE v5.0, with severity of CRS determined according to the American Society for Transplantation and Cell Therapy (ASTCT) Consensus Grading Criteria | From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks) |
| Change from baseline in vital signs[safety and tolerability] | Change from baseline in vital signs | From screening until study completion or treatment discontinuation (approximately 18 weeks) |
| Change from baseline in clinical laboratory test results and examination findings[safety and tolerability] | Change from baseline in clinical laboratory test results and examination findings specified in this study including, but not limited, electrocardiograms (ECGs) | From screening until study completion or treatment discontinuation (approximately 18 weeks) |
| Dose-limiting toxicities (DLTs) of SAIL66[safety and tolerability] | Incidence and nature of the DLTs [Q3W Dose Escalation part and QW Dose Escalation part] | From Cycle 1 Day 1 until Cycle 1 Day 21 (Cycle 1 is 21 days) |
| Preliminary anti-tumor activity of SAIL66 when administered at selected dose(s) in each cohort [Expansion part] | Objective response rate (ORR), defined as the proportion of patients with a confirmed complete response (CR) or partial response (PR) on two consecutive occasions >= 4 weeks apart, assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 by the investigators. | From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum serum concentration (Cmax) of SAIL66 [PK profile] | Maximum serum concentration (Cmax) of SAIL66 | From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks) |
| Trough serum concentration (Ctrough) of SAIL66 [PK profile] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sponsor Chugai Pharmaceutical Co. Ltd | clinical-trials@chugai-pharm.co.jp | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | United States | ||
| Georgia Cancer Center at Augusta University |
Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds\_request.html).
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Trough serum concentration (Ctrough) of SAIL66 |
| From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks) |
| Area under the concentration time-curve (AUC) of SAIL66 [PK profile] | Area under the concentration time-curve (AUC) of SAIL66 | From the first occurrence of CR or PR to progression disease (PD) or death from any cause (whichever occurs first) (approximately 18 weeks) |
| Objective response rate(ORR)[preliminary efficacy] | ORR assessed per RECIST v.1.1 by the investigators. [Q3W Dose Escalation part and QW Dose Escalation part] | From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks) |
| Duration of response (DoR)[preliminary efficacy] | Duration of response (DoR), defined as the time from the first occurrence of CR or PR to progression disease (PD) or death from any cause (whichever occurs first), per the investigator according to RECIST v.1.1 | From the first occurrence of CR or PR to progression disease (PD) or death from any cause (whichever occurs first)(whichever occurs first) (approximately 18 weeks) |
| Disease control rate (DCR)[preliminary efficacy] | Disease control rate (DCR), defined as the proportion of patients who have CR, PR, or stable disease (SD) as best overall response per RECIST v.1.1 as determined by the investigator. SD must be confirmed at the first tumor assessment as scheduled in Appendix 1 after the start of treatment (the minimum duration for SD). | From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks) |
| Progression-free survival (PFS)[preliminary efficacy] | Progression-free survival (PFS), defined as the time from administration of first study treatment to the first occurrence of disease progression or death from any cause, as determined by the investigator according to RECIST v.1.1 | From administration of first study treatment to the first occurrence of disease progression or death from any cause (approximately 18 weeks) |
| Overall survival (OS)[preliminary efficacy] | Overall survival (OS), defined as the time from administration of first study treatment to death from any cause [Expansion part] | From administration of first study treatment to death from any cause (approximately 18 weeks) |
| Immunogenicity of SAIL66[preliminary efficacy] | Incidence of ADAs to SAIL66 and potential correlation with PK parameters and safety | From Cycle 1 Day 1 (Cycle 1 is 21 days) until study completion or treatment discontinuation (approximately 18 weeks) |
| Augusta |
| Georgia |
| 30912 |
| United States |
| MUSC Hollings Cancer Center | Charleston | South Carolina | 29425 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37203 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| National Cancer Center Hospital East | Kashiwa | Chiba | 277-8577 | Japan |
| National Cancer Center Hospital | Tokyo | Chuo Ku | 104-0045 | Japan |
| Cancer Institute Hospital of JFCR | Tokyo | Koto Ku | 135-8550 | Japan |
| Shizuoka Cancer Center | Shizuoka | Sunto-gun | 411-8777 | Japan |