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

NCT05735366 | Completed Phase 1 FDA Drug

• 1 other identifier: SAL101JG
• Study Type: interventional
• Target: 22
• Locations: 2 countries
• Sites: 9

Brief 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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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)

• Dose-limiting toxicities (DLTs) of SAIL66[safety and tolerability]

  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)

• 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.

  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]

  From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)

• Trough serum concentration (Ctrough) of SAIL66 [PK profile]

  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]

  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]

  From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)

• Duration of response (DoR)[preliminary efficacy]

  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)

Study Arms (3)

Q3W Dose Escalation part

EXPERIMENTAL

Patients will receive SAIL66 as tri-weekly IV infusions at escalated doses.

Drug: SAIL66

Expansion part

EXPERIMENTAL

Patients will receive SAIL66 as a IV infusion at the recommended dose.

Drug: SAIL66

QW Dose Escalation part

EXPERIMENTAL

Patients will receive SAIL66 as a weekly IV infusion at escalated doses.

Drug: SAIL66

Interventions

SAIL66 DRUG

SAIL66 as a IV infusion

Expansion part; Q3W Dose Escalation part; QW Dose Escalation part

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chugai Pharmaceutical: lead

Study Sites (9)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Location

Georgia Cancer Center at Augusta University

Augusta, Georgia, 30912, United States

Location

MUSC Hollings Cancer Center

Charleston, South Carolina, 29425, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

Location

National Cancer Center Hospital

Tokyo, Chuo Ku, 104-0045, Japan

Location

Cancer Institute Hospital of JFCR

Tokyo, Koto Ku, 135-8550, Japan

Location

Shizuoka Cancer Center

Shizuoka, Sunto-gun, 411-8777, Japan

Location

Study Officials

• Sponsor Chugai Pharmaceutical Co. Ltd

  clinical-trials@chugai-pharm.co.jp

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 21, 2023
• Study Start: April 17, 2023
• Primary Completion: January 26, 2026
• Study Completion: January 26, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

JP (4); US (5)