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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

231 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-18

Study Completion Date

2029-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Q3W Dose Escalation part

Patients will receive SAIL66 as tri-weekly IV infusions at escalated doses.

Group Type EXPERIMENTAL

SAIL66

Intervention Type DRUG

SAIL66 as a IV infusion

Expansion part

Patients will receive SAIL66 as a IV infusion at the recommended dose.

Group Type EXPERIMENTAL

SAIL66

Intervention Type DRUG

SAIL66 as a IV infusion

QW Dose Escalation part

Patients will receive SAIL66 as a weekly IV infusion at escalated doses.

Group Type EXPERIMENTAL

SAIL66

Intervention Type DRUG

SAIL66 as a IV infusion

Interventions

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SAIL66

SAIL66 as a IV infusion

Intervention Type DRUG

Eligibility Criteria

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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

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 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No