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Trial Title:
A Phase 1 Study of SAIL66 in Patients With CLDN6-positive Locally Advanced or Metastatic Solid Tumors
NCT ID:
NCT05735366
Condition:
Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SAIL66
Description:
SAIL66 as a IV infusion
Arm group label:
Expansion part
Arm group label:
Q3W Dose Escalation part
Arm group label:
QW Dose Escalation part
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.
Criteria for eligibility:
Criteria:
Inclusion 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
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, 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Banner MD Anderson Cancer Center
Address:
City:
Gilbert
Zip:
85234
Country:
United States
Status:
Recruiting
Facility:
Name:
Georgia Cancer Center at Augusta University
Address:
City:
Augusta
Zip:
30912
Country:
United States
Status:
Recruiting
Facility:
Name:
MUSC Hollings Cancer Center
Address:
City:
Charleston
Zip:
29425
Country:
United States
Status:
Recruiting
Facility:
Name:
Tennessee Oncology, PLLC
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Tokyo
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Facility:
Name:
Cancer Institute Hospital of JFCR
Address:
City:
Tokyo
Zip:
135-8550
Country:
Japan
Status:
Recruiting
Facility:
Name:
Shizuoka Cancer Center
Address:
City:
Shizuoka
Zip:
411-8777
Country:
Japan
Status:
Recruiting
Start date:
April 18, 2023
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Chugai Pharmaceutical
Agency class:
Industry
Source:
Chugai Pharmaceutical
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05735366
