Solid TumorPhase 1NCT05735366
A Phase 1 Study of SAIL66 in Patients With CLDN6-positive Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing SAIL66 in people with Solid Tumor, run by Chugai Pharmaceutical at 9 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- SAIL66
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 17 Apr 2023to 26 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States5 sites
Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912
MUSC Hollings Cancer Center
Charleston, South Carolina, 29425
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
Japan4 sites
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
Shizuoka Cancer Center
Shizuoka, Sunto-gun, 411-8777
National Cancer Center Hospital
Tokyo, Chuo Ku, 104-0045
Cancer Institute Hospital of JFCR
Tokyo, Koto Ku, 135-8550
About this study
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
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.
- Conditions
- Solid Tumor
- Being tested
- SAIL66
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAIL66Drug
SAIL66 as a IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Q3W Dose Escalation part | Experimental | Patients will receive SAIL66 as tri-weekly IV infusions at escalated doses. Receives: Drug: SAIL66 |
| Expansion part | Experimental | Patients will receive SAIL66 as a IV infusion at the recommended dose. Receives: Drug: SAIL66 |
| QW Dose Escalation part | Experimental | Patients will receive SAIL66 as a weekly IV infusion at escalated doses. Receives: Drug: SAIL66 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Measured: 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]
Measured: 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.
Measured: From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)
Secondary outcomes (9)
Maximum serum concentration (Cmax) of SAIL66 [PK profile]
Maximum serum concentration (Cmax) of SAIL66
Measured: From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)
Trough serum concentration (Ctrough) of SAIL66 [PK profile]
Trough serum concentration (Ctrough) of SAIL66
Measured: 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
Measured: 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]
Measured: 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
Measured: 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).
Measured: 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
Measured: 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]
Measured: 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
Measured: From Cycle 1 Day 1 (Cycle 1 is 21 days) until study completion or treatment discontinuation (approximately 18 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start17 Apr 2023
- Primary completion26 Jan 2026
- Study completion26 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sponsor Chugai Pharmaceutical Co. Ltd, Study director, clinical-trials@chugai-pharm.co.jp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735366
- Sponsor's protocol ID
- SAL101JG
- Status last verified
- Mar 2026
- First submitted
- 27 Jan 2023
- Last updated
- 10 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05735366
- Acronym / sponsor ID
- SAL101JG
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 26 Jan 2026 (actual)
- Study completion
- 26 Jan 2026 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Q3W Dose Escalation part | Experimental | Drug: SAIL66Patients will receive SAIL66 as tri-weekly IV infusions at escalated doses. |
| Expansion part | Experimental | Drug: SAIL66Patients will receive SAIL66 as a IV infusion at the recommended dose. |
| QW Dose Escalation part | Experimental | Drug: SAIL66Patients will receive SAIL66 as a weekly IV infusion at escalated doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAIL66SAIL66 as a IV infusion | Drug | Expansion part, Q3W Dose Escalation part, QW Dose Escalation part |
Primary outcome
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
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
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)
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]
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.
9 secondary outcomes
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)
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)
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)
Objective response rate(ORR)[preliminary efficacy]
Time frame: 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)
Disease control rate (DCR)[preliminary efficacy]
Time frame: 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)
Overall survival (OS)[preliminary efficacy]
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sponsor Chugai Pharmaceutical Co. Ltd study director
clinical-trials@chugai-pharm.co.jp
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SAIL66 in people with Solid Tumor, run by Chugai Pharmaceutical at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events of SAIL66[safety and tolerability] (time frame: From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.