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ION537 for Solid Tumors

Phase 1

Waitlist Available

Research Sponsored by Ionis Pharmaceuticals, Inc.

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 up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)

Awards & highlights

Study Summary

This trial is testing a new drug to see what doses are safe and effective for treating patients with advanced solid tumors.

Eligible Conditions

Solid Tumors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Inhibition of Yes-associated Protein (YAP1) Expression

Number of Participants With Dose-limiting Toxicities (DLTs)

Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Treatment-emergent Serious Adverse Event (TESAE), Graded by Severity

+3 more

Secondary outcome measures

Area Under the Plasma Concentration-Time Curve from Hour Zero to Hour 24 AUC[0-24] for ION537

Clinical Benefit Rate (CBR)

Duration of Response (DoR)

+9 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: ION537Experimental Treatment1 Intervention

Multiple ascending doses of ION537 will be administered by intravenous (IV) injection on Days 1, 4, 8, 11, 15, and 22 in Cycle 1 and weekly dosing in each subsequent cycle until disease progression.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ION537

2021

Completed Phase 1

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ionis Pharmaceuticals, Inc.Lead Sponsor

146 Previous Clinical Trials

15,267 Total Patients Enrolled

M.D. Anderson Cancer CenterOTHER

2,966 Previous Clinical Trials

1,804,766 Total Patients Enrolled

Frequently Asked Questions

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

Approximately how many participants are taking part in this clinical trial?

"Indeed, the clinicaltrials.gov webpage confirms that this examination is currently searching for volunteers to join. It was launched on May 1st 2021 and most recently modified October 13th 2022; 102 individuals from a single site are being recruited."

Answered by AI

Has ION537 been corroborated by the Food and Drug Administration?

"Our team of researchers at Power have assessed the safety profile of ION537 to be a 1. This is due to this being an early stage experiment, thus there are limited data points verifying its efficacy and reliability from a patient's perspective."

Answered by AI

Are there openings available for potential participants in this research?

"Affirmative. Clinicaltrials.gov's records show that since it was initially posted on May 1st 2021, this study has been actively seeking participants. 102 patients are required to enroll at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of ION537 in Patients With Molecularly Selected Advanced Solid Tumors

2021. "A Study of ION537 in Patients With Molecularly Selected Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04659096.