ACTIVE_NOT_RECRUITING

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

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Conditions

Solid Tumor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-04-18
Study Completion:2029-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05735366

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years at time of signing Informed Consent Form
  2. * Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1
  3. * Patient must have tumor specimen available for central pathology review and confirmed as CLDN6-positive
  4. * (For male patients) Agreement to stay abstinent or use contraceptive measures with female partners, and agreement to refrain from donating sprerm during the treatment
  1. * Intending to become pregnant or breastfeed during the study and within 3 months after the last dose of SAIL66 or tocilizumab, whichever is longer
  2. * Primary central nervous system (CNS) malignancy, symptomatic (seizures etc.) CNS metastases or CNS metastases required any anti-cancer treatment
  3. * 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
  4. * Uncontrolled tumor-related pain
  5. * Uncontrolled pleural effusion, pericardial effusion, or ascites

Contacts and Locations

Principal Investigator

Sponsor Chugai Pharmaceutical Co. Ltd
STUDY_DIRECTOR
clinical-trials@chugai-pharm.co.jp

Study Locations (Sites)

Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
United States
Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912
United States
MUSC Hollings Cancer Center
Charleston, South Carolina, 29425
United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Chugai Pharmaceutical

  • Sponsor Chugai Pharmaceutical Co. Ltd, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2023-04-18
Study Completion Date2029-10-31

Study Record Updates

Study Start Date2023-04-18
Study Completion Date2029-10-31

Terms related to this study

Additional Relevant MeSH Terms

  • Solid Tumor