Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

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

ID
Name
SAL101JG
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.
Trial arms
Trial start
2023-04-18
Estimated PCD
2028-12-31
Trial end
2028-12-31
Status
Recruiting
Phase
Early phase I
Treatment
SAIL66
SAIL66 as a IV infusion
Arms:
Part1: Dose Escalation part, Part2: Expansion part
Tocilizumab
Tocilizumab as a IV infusion
Arms:
Part1: Dose Escalation part, Part2: Expansion part
Size
178
Primary endpoint
Adverse events of SAIL66[safety and tolerability]
From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)
Change from baseline in vital signs[safety and tolerability]
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]
From screening until study completion or treatment discontinuation (approximately 18 weeks)
Dose-limiting toxicities (DLTs) of SAIL66[safety and tolerability]
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 [Part 2]
From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 178, 'type': 'ESTIMATED'}}
Updated at
2023-11-09

1 organization

2 products

1 indication

Organization
Chugai Pharmaceutical
Product
Tocilizumab
Indication
Solid Tumor
Product
SAIL66