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Completed

NCT Number: NCT05735366

A Phase 1 Study 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.

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Key information

Conditions

Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Cancer Center Hospital East, Kashiwa, Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SAIL66

Drug

SAIL66 as a IV infusion

Primary outcomes

  1. 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

  2. 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

  3. 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)

  4. 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]

  5. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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]

  5. 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

  6. 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).

  7. 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

  8. 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]

  9. 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

Sponsors and collaborators

Lead sponsor

Chugai Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 21, 2023
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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