A Phase 1 Study of SAIL66 in Patients With CLDN6-positive Locally Advanced or Metastatic Solid Tumors
- Registration Number
- NCT05735366
- Lead Sponsor
- Chugai Pharmaceutical
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 231
- Age ≥ 18 years at time of signing Informed Consent Form
- Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1
- Patient must have tumor specimen available for central pathology review and confirmed as CLDN6-positive
- (For male patients) Agreement to stay abstinent or use contraceptive measures with female partners, and agreement to refrain from donating sprerm during the treatment and for 3 months after the final dose of obinutuzumab.
- Intending to become pregnant or breastfeed during the study and within 3 months after the last dose of SAIL66 or tocilizumab, or within 18 months after the last dose of obinutuzumab, whichever is longer
- Primary central nervous system (CNS) malignancy, symptomatic (seizures etc.) CNS metastases or CNS metastases required any anti-cancer treatment
- History or presence of CNS disease such as stroke (e.g., subarachnoid hemorrhage or cerebral infarction), epilepsy, CNS vasculitis, neurodegenerative disease, aphasia, dementia or paresis
- Uncontrolled tumor-related pain
- Uncontrolled pleural effusion, pericardial effusion, or ascites
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Q3W Dose Escalation part SAIL66 Patients will receive SAIL66 as tri-weekly IV infusions at escalated doses. QW Dose Escalation part with/without obinutuzumab premedication SAIL66 Patients will receive SAIL66 as a weekly IV infusion at escalated doses, with or without obinutuzumab premedication. QW Dose Escalation part with/without obinutuzumab premedication Obinutuzumab Patients will receive SAIL66 as a weekly IV infusion at escalated doses, with or without obinutuzumab premedication. Expansion part SAIL66 Patients will receive SAIL66 as a IV infusion at the recommended dose.
- Primary Outcome Measures
Name Time Method Adverse events of SAIL66[safety and tolerability] From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks) 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
Change from baseline in vital signs[safety and tolerability] From screening until study completion or treatment discontinuation (approximately 18 weeks) Change from baseline in vital signs
Change from baseline in clinical laboratory test results and examination findings[safety and tolerability] From screening until study completion or treatment discontinuation (approximately 18 weeks) Change from baseline in clinical laboratory test results and examination findings specified in this study including, but not limited, electrocardiograms (ECGs)
Dose-limiting toxicities (DLTs) of SAIL66[safety and tolerability] From Cycle 1 Day 1 until Cycle 1 Day 21 (Cycle 1 is 21 days) Incidence and nature of the DLTs \[Q3W Dose Escalation part and QW Dose Escalation part with/without obinutuzumab\]
Preliminary anti-tumor activity of SAIL66 when administered at selected dose(s) in each cohort [Expansion part] From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks) 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.
- Secondary Outcome Measures
Name Time Method Maximum serum concentration (Cmax) of SAIL66 with or without obinutuzumab[PK profile] From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks) Maximum serum concentration (Cmax) of SAIL66 with or without obinutuzumab
Trough serum concentration (Ctrough) of SAIL66 with or without obinutuzumab[PK profile] From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks) Trough serum concentration (Ctrough) of SAIL66 with or without obinutuzumab
Area under the concentration time-curve (AUC) of SAIL66 with or without obinutuzumab[PK profile] From the first occurrence of CR or PR to progression disease (PD) or death from any cause (whichever occurs first) (approximately 18 weeks) Area under the concentration time-curve (AUC) of SAIL66 with or without obinutuzumab
Objective response rate(ORR)[preliminary efficacy] From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks) ORR assessed per RECIST v.1.1 by the investigators. \[Q3W Dose Escalation part and QW Dose Escalation part with/without obinutuzumab\]
Duration of response (DoR)[preliminary efficacy] 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) 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
Disease control rate (DCR)[preliminary efficacy] From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks) 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).
Progression-free survival (PFS)[preliminary efficacy] From administration of first study treatment to the first occurrence of disease progression or death from any cause (approximately 18 weeks) 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
Overall survival (OS)[preliminary efficacy] From administration of first study treatment to death from any cause (approximately 18 weeks) Overall survival (OS), defined as the time from administration of first study treatment to death from any cause \[Expansion part\]
Immunogenicity of SAIL66[preliminary efficacy] From Cycle 1 Day 1 (Cycle 1 is 21 days) until study completion or treatment discontinuation (approximately 18 weeks) Incidence of ADAs to SAIL66 and potential correlation with PK parameters and safety
Maximum serum concentration (Cmax) of obinutuzumab[PK profile] From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks) Maximum serum concentration (Cmax) of obinutuzumab (In parts with obinutuzumab premedication)
Area under the concentration time-curve (AUC) of obinutuzumab[PK profile] From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks) Area under the concentration time-curve (AUC) of obinutuzumab (In parts with obinutuzumab premedication)
Immunogenicity of obinutuzumab[preliminary efficacy] From the day of the first obinutuzumab administration until study completion or treatment discontinuation (approximately 18 weeks) Incidence of ADAs to obinutuzumab and potential correlation with PK parameters and safety (In parts with obinutuzumab premedication)
Adverse events of obinutuzumab[safety and tolerability] From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks) 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(In parts with obinutuzumab premedication)
Trial Locations
- Locations (9)
Georgia Cancer Center at Augusta University
🇺🇸Augusta, Georgia, United States
MUSC Hollings Cancer Center
🇺🇸Charleston, South Carolina, United States
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
Tennessee Oncology, PLLC
🇺🇸Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
National Cancer Center Hospital East
🇯🇵Kashiwa, Chiba, Japan
National Cancer Center Hospital
🇯🇵Tokyo, Chuo Ku, Japan
Cancer Institute Hospital of JFCR
🇯🇵Tokyo, Koto Ku, Japan
Shizuoka Cancer Center
🇯🇵Shizuoka, Sunto-gun, Japan