Clinical trial NCT05735366: A Phase 1 Study 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2023-02-21
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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 and for 3 months after the final dose of obinutuzumab.

Exclusion Criteria:

* Intending to become pregnant or breastfeed during the study and within 3 months after the last dose of SAIL66 or tocilizumab, or within 18 months after the last dose of obinutuzumab, 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

Primary outcomes:
measure: Adverse events of SAIL66[safety and tolerability]
timeFrame: From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)
measure: Change from baseline in vital signs[safety and tolerability]
timeFrame: From screening until study completion or treatment discontinuation (approximately 18 weeks)
measure: Change from baseline in clinical laboratory test results and examination findings[safety and tolerability]
timeFrame: From screening until study completion or treatment discontinuation (approximately 18 weeks)
measure: Dose-limiting toxicities (DLTs) of SAIL66[safety and tolerability]
timeFrame: From Cycle 1 Day 1 until Cycle 1 Day 21 (Cycle 1 is 21 days)
measure: Preliminary anti-tumor activity of SAIL66 when administered at selected dose(s) in each cohort [Expansion part]
timeFrame: From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)
Secondary outcomes:
measure: Maximum serum concentration (Cmax) of SAIL66 with or without obinutuzumab[PK profile]
timeFrame: From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)
measure: Trough serum concentration (Ctrough) of SAIL66 with or without obinutuzumab[PK profile]
timeFrame: From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)
measure: Area under the concentration time-curve (AUC) of SAIL66 with or without obinutuzumab[PK profile]
timeFrame: From the first occurrence of CR or PR to progression disease (PD) or death from any cause (whichever occurs first) (approximately 18 weeks)
measure: Objective response rate(ORR)[preliminary efficacy]
timeFrame: From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)
measure: Duration of response (DoR)[preliminary efficacy]
timeFrame: 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)
measure: Disease control rate (DCR)[preliminary efficacy]
timeFrame: From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)
measure: Progression-free survival (PFS)[preliminary efficacy]
timeFrame: From administration of first study treatment to the first occurrence of disease progression or death from any cause (approximately 18 weeks)
measure: Overall survival (OS)[preliminary efficacy]
timeFrame: From administration of first study treatment to death from any cause (approximately 18 weeks)
measure: Immunogenicity of SAIL66[preliminary efficacy]
timeFrame: From Cycle 1 Day 1 (Cycle 1 is 21 days) until study completion or treatment discontinuation (approximately 18 weeks)
measure: Maximum serum concentration (Cmax) of obinutuzumab[PK profile]
timeFrame: From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)
measure: Area under the concentration time-curve (AUC) of obinutuzumab[PK profile]
timeFrame: From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)
measure: Immunogenicity of obinutuzumab[preliminary efficacy]
timeFrame: From the day of the first obinutuzumab administration until study completion or treatment discontinuation (approximately 18 weeks)
measure: Adverse events of obinutuzumab[safety and tolerability]
timeFrame: From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Augusta
country: United States
facility: Georgia Cancer Center at Augusta University
state: Georgia
city: Charleston
country: United States
facility: MUSC Hollings Cancer Center
state: South Carolina
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
state: Chuo Ku
city: Tokyo
country: Japan
facility: Cancer Institute Hospital of JFCR
state: Koto Ku
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center
state: Sunto-gun
Study officials:
affiliation: clinical-trials@chugai-pharm.co.jp
name: Sponsor Chugai Pharmaceutical Co. Ltd
role: STUDY_DIRECTOR
References: