- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05735366
A Phase 1 Study of SAIL66 in Patients With CLDN6-positive Locally Advanced or Metastatic Solid Tumors
November 7, 2023 updated by: Chugai Pharmaceutical
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
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.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
178
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Clinical trials information
- Phone Number: only use Email
- Email: clinical-trials@chugai-pharm.co.jp
Study Locations
-
-
Chiba
-
Kashiwa, Chiba, Japan, 277-8577
- Recruiting
- National Cancer Center Hospital East
-
-
Chuo Ku
-
Tokyo, Chuo Ku, Japan, 104-0045
- Recruiting
- National Cancer Center Hospital
-
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Koto Ku
-
Tokyo, Koto Ku, Japan, 135-8550
- Recruiting
- Cancer Institute Hospital of JFCR
-
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Sunto-gun
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Shizuoka, Sunto-gun, Japan, 411-8777
- Recruiting
- Shizuoka Cancer Center
-
-
-
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Texas
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Houston, Texas, United States, 77030
- Recruiting
- The University of Texas MD Anderson Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part1: Dose Escalation part
Patients will receive SAIL66 as a IV infusion at escalated doses.
|
SAIL66 as a IV infusion
Tocilizumab as a IV infusion
|
Experimental: Part2: Expansion part
Patients will receive SAIL66 as a IV infusion at the recommended dose.
|
SAIL66 as a IV infusion
Tocilizumab as a IV infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events of SAIL66[safety and tolerability]
Time Frame: 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
|
From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)
|
Change from baseline in vital signs[safety and tolerability]
Time Frame: From screening until study completion or treatment discontinuation (approximately 18 weeks)
|
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]
Time Frame: 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)
|
From screening until study completion or treatment discontinuation (approximately 18 weeks)
|
Dose-limiting toxicities (DLTs) of SAIL66[safety and tolerability]
Time Frame: From Cycle 1 Day 1 until Cycle 1 Day 21 (Cycle 1 is 21 days)
|
Incidence and nature of the DLTs
|
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 [Part 2]
Time Frame: 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.
|
From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum serum concentration (Cmax) of SAIL66[PK profile]
Time Frame: From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)
|
Maximum serum concentration (Cmax) 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]
Time Frame: 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
|
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]
Time Frame: 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.
[Part 1]
|
From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)
|
Duration of response (DoR)[preliminary efficacy]
Time Frame: 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
|
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]
Time Frame: 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).
|
From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)
|
Progression-free survival (PFS)[preliminary efficacy]
Time Frame: 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
|
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]
Time Frame: 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 [Part 2]
|
From administration of first study treatment to death from any cause (approximately 18 weeks)
|
Immunogenicity of SAIL66[preliminary efficacy]
Time Frame: 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
|
From Cycle 1 Day 1 (Cycle 1 is 21 days) until study completion or treatment discontinuation (approximately 18 weeks)
|
Trough serum concentration (Ctrough) of SAIL66[PK profile]
Time Frame: From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)
|
Trough serum concentration (Ctrough) of SAIL66
|
From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Sponsor Chugai Pharmaceutical Co. Ltd, clinical-trials@chugai-pharm.co.jp
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 18, 2023
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Study Registration Dates
First Submitted
January 27, 2023
First Submitted That Met QC Criteria
February 9, 2023
First Posted (Actual)
February 21, 2023
Study Record Updates
Last Update Posted (Estimated)
November 9, 2023
Last Update Submitted That Met QC Criteria
November 7, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAL101JG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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).
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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