A Phase 1 Study of SAIL66 in Patients With CLDN6-positive Locally Advanced or Metastatic Solid Tumors

Solid Tumor Clinical Trial

Official title:

A Phase I Open-label, Multicenter Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of SAIL66 in Patients With CLDN6-positive Locally Advanced or Metastatic Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05735366
• Other study ID #: SAL101JG
• Status: Recruiting
• Phase: Phase 1
• Start date: April 18, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: June 2024
• Source: Chugai Pharmaceutical
• Contact: Clinical trials information
• Phone: Only use Email
• Email: clinical-trials[@]chugai-pharm.co.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years at time of signing Informed Consent Form

• Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1

• Patients with CLDN6 positive solid tumors

Exclusion Criteria:

• Intending to become pregnant or breastfeed during the study and within 3 months after the last dose of SAIL66 or tocilizumab, whichever is longer

• Primary central nervous system (CNS) malignancy, symptomatic (seizures etc.) CNS metastases, actively progressing 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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• SAIL66
SAIL66 as a IV infusion

Locations

Country	Name	City	State
Japan	National Cancer Center Hospital East	Kashiwa	Chiba
Japan	Shizuoka Cancer Center	Shizuoka	Sunto-gun
Japan	Cancer Institute Hospital of JFCR	Tokyo	Koto Ku
Japan	National Cancer Center Hospital	Tokyo	Chuo Ku
United States	Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Tennessee Oncology, PLLC	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Chugai Pharmaceutical

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	Dose-limiting toxicities (DLTs) of SAIL66[safety and tolerability]	Incidence and nature of the DLTs	From Cycle 1 Day 1 until Cycle 1 Day 21 (Cycle 1 is 21 days)
Primary	Preliminary anti-tumor activity of SAIL66 when administered at selected dose(s) in each cohort [Part 2]	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)
Secondary	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)
Secondary	Trough serum concentration (Ctrough) of SAIL66[PK profile]	Trough serum concentration (Ctrough) of SAIL66	From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)
Secondary	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)
Secondary	Objective response rate(ORR)[preliminary efficacy]	ORR assessed per RECIST v.1.1 by the investigators. [Part 1 and Part 3]	From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Overall survival (OS)[preliminary efficacy]	Overall survival (OS), defined as the time from administration of first study treatment to death from any cause [Part 2]	From administration of first study treatment to death from any cause (approximately 18 weeks)
Secondary	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)