Study Summary
This trial is testing a new drug, CLN-619, to see if it can shrink tumors when used alone or with another drug, pembrolizumab.
- Advanced Solid Tumors
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
2 Primary · 1 Secondary · Reporting Duration: Up to 2 years
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
6 Treatment Groups
Module B Combination Therapy Safety Cohort
1 of 6
Module B Combination Therapy Dose Escalation
1 of 6
Module B Combination Therapy Dose Escalation Cohort
1 of 6
Module A Cohort Expansion
1 of 6
Module B Combination Therapy Cohort Expansion
1 of 6
Module A Dose Escalation
1 of 6
Experimental Treatment
410 Total Participants · 6 Treatment Groups
Primary Treatment: CLN-619 · No Placebo Group · Phase 1
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
Is this experiment still open to new participants?
"Per the information posted on clinicaltrials.gov, this trial has been ongoing since October 29th 2021 and is currently seeking new participants; it was last updated July 15th 2022." - Anonymous Online Contributor
Can you provide an estimate of how many people are involved in this research?
"Affirmatively, current records on clinicaltrials.gov demonstrate that this medical trial is currently seeking participants. It was originally made available to the public on October 29th 2021 and has been updated most recently on July 15th 2022. The study envisions recruiting 148 patients from 9 different sites." - Anonymous Online Contributor
How many facilities are conducting this experiment?
"Patients are being recruited for this trail at Florida Cancer Specialists in Sarasota, START San Antonio in Nashville, Sarah Cannon Research Institute in Grand Rapids and 9 other medical centers." - Anonymous Online Contributor
To what ailments has the efficacy of CLN-619 been demonstrated?
"Beneficial results can be achieved when treating malignant neoplasms, microsatellite instability high, and inoperable melanoma with CLN-619." - Anonymous Online Contributor
What potential risks come with exposure to CLN-619?
"The potential safety of CLN-619 is yet to be fully established, so it received a score of 1. This assessment was based on the fact that this is presently in its first phase of testing and there are limited studies validating both efficacy and security." - Anonymous Online Contributor
What other research endeavors have been conducted involving CLN-619?
"CLN-619 first received clinical attention in 2010 from the City of Hope. At this time, there have been 251 trials to complete their testing and 963 that are still active with a concentration in Sarasota, Florida." - Anonymous Online Contributor