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

March 9, 2026 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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Japan
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
    • Chuo Ku
      • Tokyo, Chuo Ku, Japan, 104-0045
        • National Cancer Center Hospital
    • Koto Ku
      • Tokyo, Koto Ku, Japan, 135-8550
        • Cancer Institute Hospital of JFCR
    • Sunto-gun
      • Shizuoka, Sunto-gun, Japan, 411-8777
        • Shizuoka Cancer Center
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson Cancer Center
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Georgia Cancer Center at Augusta University
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • MUSC Hollings Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology, PLLC
    • Texas
      • Houston, Texas, United States, 77030
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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
  • 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

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 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Expansion part
Patients will receive SAIL66 as a IV infusion at the recommended dose.
Drug: SAIL66
SAIL66 as a IV infusion
Experimental: Q3W Dose Escalation part
Patients will receive SAIL66 as tri-weekly IV infusions at escalated doses.
Drug: SAIL66
SAIL66 as a IV infusion
Experimental: QW Dose Escalation part
Patients will receive SAIL66 as a weekly IV infusion at escalated doses.
Drug: SAIL66
SAIL66 as a IV infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
Preliminary anti-tumor activity of SAIL66 when administered at selected dose(s) in each cohort [Expansion part]
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)
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 [Q3W Dose Escalation part and QW Dose Escalation part]
From Cycle 1 Day 1 until Cycle 1 Day 21 (Cycle 1 is 21 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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)
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 [Expansion part]
From administration of first study treatment to death from any cause (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. [Q3W Dose Escalation part and QW Dose Escalation part]
From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)
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)
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chugai Pharmaceutical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 17, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 26, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 26, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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