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CLN-619 for Solid Tumors

START Midwest, San Antonio, TX
Solid TumorsCLN-619 - Drug
Eligibility
18+
All Sexes

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.

Eligible Conditions
  • Advanced Solid Tumors

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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Study Objectives

2 Primary · 1 Secondary · Reporting Duration: Up to 2 years

24 Months
Dose Escalation
Month 36
Dose Expansion
Up to 2 years
All Cohorts

Trial Safety

Phase-Based Safety

1 of 3

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1
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1
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

Module B Combination Therapy Safety CohortExperimental Group · 2 Interventions: CLN-619, Pembrolizumab · Intervention Types: Drug, Drug
Module B Combination Therapy Dose EscalationExperimental Group · 2 Interventions: CLN-619, Pembrolizumab · Intervention Types: Drug, Drug
Module B Combination Therapy Dose Escalation CohortExperimental Group · 2 Interventions: CLN-619, Pembrolizumab · Intervention Types: Drug, Drug
Module A Cohort Expansion
Drug
Experimental Group · 1 Intervention: CLN-619 · Intervention Types: Drug
Module B Combination Therapy Cohort ExpansionExperimental Group · 2 Interventions: CLN-619, Pembrolizumab · Intervention Types: Drug, Drug
Module A Dose Escalation
Drug
Experimental Group · 1 Intervention: CLN-619 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

Cullinan Oncology, LLCLead Sponsor
5 Previous Clinical Trials
556 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have cancer that has spread to other parts of your body or has grown too large to be removed by surgery. For one part of the study, your type of cancer is included in the list of approved cancers that can be treated with pembrolizumab.
You don't need to have received previous treatment with CPI (checkpoint inhibitors) to participate in Module A Expansion A2 for cervical carcinoma.
References

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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