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

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.

Conditions

Solid Tumor

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Gilbert

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States, 85234

Augusta

Georgia Cancer Center at Augusta University, Augusta, Georgia, United States, 30912

Charleston

MUSC Hollings Cancer Center, Charleston, South Carolina, United States, 29425

Nashville

Tennessee Oncology, PLLC, Nashville, Tennessee, United States, 37203

Houston

The University of Texas MD Anderson Cancer Center, Houston, Texas, United States, 77030

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age ≥ 18 years at time of signing Informed Consent Form
  • * Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1
  • * Patients with CLDN6 positive solid tumors
  • * 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, actively progressing 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Chugai Pharmaceutical,

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

Study Record Dates

2028-12-31