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Monoclonal Antibodies

SAIL66 for Solid Tumors

Phase 1

Recruiting

Research Sponsored by Chugai Pharmaceutical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from cycle 1 day 1 until cycle 1 day 21 (cycle 1 is 21 days)

Awards & highlights

Study Summary

This trial tests a new drug to see if it's safe and effective for treating certain types of cancer.

Who is the study for?

Adults over 18 with CLDN6-positive advanced or metastatic solid tumors can join this trial. They must be in good physical condition, meaning they're fully active or have some symptoms but can still do light work (ECOG PS of 0 or 1). A tumor sample for review is also required.Check my eligibility

What is being tested?

The study tests SAIL66's safety and how well it works in patients. It starts by giving small doses to a few people and slowly increasing the amount. Researchers will watch how the body reacts to it (PK/PD) and if it helps shrink the tumors.See study design

What are the potential side effects?

Since this is an early-phase trial, specific side effects of SAIL66 are being studied. However, common side effects may include reactions at the injection site, flu-like symptoms, fatigue, and possible changes in blood test results.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from cycle 1 day 1 until cycle 1 day 21 (cycle 1 is 21 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from cycle 1 day 1 until cycle 1 day 21 (cycle 1 is 21 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from cycle 1 day 1 until cycle 1 day 21 (cycle 1 is 21 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse events of SAIL66[safety and tolerability]

Change from baseline in clinical laboratory test results and examination findings[safety and tolerability]

Change from baseline in vital signs[safety and tolerability]

+2 more

Secondary outcome measures

Area under the concentration time-curve (AUC) of SAIL66[PK profile]

Disease control rate (DCR)[preliminary efficacy]

Duration of response (DoR)[preliminary efficacy]

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part2: Expansion partExperimental Treatment2 Interventions

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

Group II: Part1: Dose Escalation partExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tocilizumab

2012

Completed Phase 4

~1840

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Chugai PharmaceuticalLead Sponsor

95 Previous Clinical Trials

21,526 Total Patients Enrolled

Sponsor Chugai Pharmaceutical Co. LtdStudy Directorclinical-trials@chugai-pharm.co.jp

9 Previous Clinical Trials

692 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial have an open enrollment period?

"Affirmative. Per the clinical trial information on clinicialtrials.gov, this medical study is recruiting participants as of November 7th 2023. It was initially posted on April 18th, and it seeks to admit 178 patients from 6 different sites."

Answered by AI

How many locations can participants access this research experiment?

"At this moment, 6 sites are currently admitting participants into the study — Tokyo, Shizuoka and Houston included. To reduce travel costs associated with participation in the trial, it is best to pick a site that's closest to you."

Answered by AI

Is the Part2: Expansion segment of this product compliant with FDA regulations?

"The safety of the Part2: Expansion part is tentatively assessed as level 1 due to it being a Phase 1 trial and the lack of evidence for both efficacy and security."

Answered by AI

What is the total sample size involved in this research endeavor?

"Chugai Pharmaceutical is looking to enroll 178 suitable participants from multiple sites, including Cancer Institute Hospital of JFCR in Tokyo, Chuo Ku and Shizuoka Cancer Center in Shizuoka, Koto Ku."

Answered by AI

What is the desired outcome of this clinical experiment?

"This clinical trial, sponsored by Chugai Pharmaceutical, aims to assess the safety and tolerability of SAIL66 through Change from baseline in laboratory tests results and examination findings. The Area under the concentration time-curve (AUC) will also be evaluated as a secondary outcome measure along with Duration of response (DoR) and Disease control rate (DCR). All outcomes are measured over an 18 week period starting at screening until study completion or treatment discontinuation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Phase 1 Study of SAIL66 in Patients With CLDN6-positive Locally Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05735366.