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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate liver and kidney function and hematological parameters within a normal range
Module A Monotherapy Dose Escalation Cohort and Module B Combination Therapy Dose Escalation Cohorts: Histologically or cytologically-confirmed metastatic or locally advanced, unresectable solid tumors. For Module B, tumor type is listed as an approved indication per the current prescribing information for pembrolizumab.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
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.
Who is the study for?
Adults with advanced solid tumors, including specific types such as NSCLC, cervical cancer, HNSCC, and urothelial carcinoma. Participants must have measurable disease, acceptable organ function and performance status. Prior treatments are specified for each cohort. Pregnant or breastfeeding women and those unwilling to prevent pregnancy or donate sperm during the study are excluded.Check my eligibility
What is being tested?
The trial is testing CLN-619 alone and combined with Pembrolizumab in patients with various advanced solid tumors. It's an early-phase (Phase 1), open-label study which means both researchers and participants know what treatment is being given.See study design
What are the potential side effects?
Potential side effects may include typical reactions associated with immunotherapy such as inflammation of organs, infusion-related reactions, fatigue, possible immune system complications like pneumonitis or colitis, liver issues meeting Hy's Law criteria.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver, kidneys, and blood counts are healthy.
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My cancer is advanced, cannot be surgically removed, and for Module B, it's a type treatable with pembrolizumab.
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My lung cancer is advanced and cannot be removed with surgery.
Select...
Side effects from my previous cancer treatment are mild now.
Select...
My bladder cancer cannot be removed by surgery and has spread.
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My head or neck cancer cannot be removed by surgery and has spread.
Select...
My NSCLC worsened after treatment with specific immune therapies or targeted therapies for EGFR or ALK mutations.
Select...
My lung cancer is advanced and cannot be removed with surgery.
Select...
My cervical cancer is advanced and cannot be removed with surgery.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose Escalation
Dose Expansion
Secondary outcome measures
All Cohorts
Trial Design
4Treatment groups
Experimental Treatment
Group I: Module B Combination Therapy Dose EscalationExperimental Treatment2 Interventions
Patients with advanced solid tumors enrolled in dose escalation cohorts treated with CLN-619 in combination with pembrolizumab
Group II: Module B Combination Therapy Cohort ExpansionExperimental Treatment2 Interventions
Patients with select tumor types enrolled in expansion cohorts treated with CLN-619 at a dose selected from the Module B Escalation arm, in combination with pembrolizumab
Group III: Module A Dose EscalationExperimental Treatment1 Intervention
Patients with advanced solid tumors enrolled in dose escalation cohorts treated with CLN-619
Group IV: Module A Cohort ExpansionExperimental Treatment1 Intervention
Patients with select solid tumor types enrolled in expansion cohorts treated with CLN-619 at a dose selected from the Module A Escalation arm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Cullinan Therapeutics Inc.Lead Sponsor
5 Previous Clinical Trials
358 Total Patients Enrolled
Cullinan Oncology Inc.Lead Sponsor
5 Previous Clinical Trials
358 Total Patients Enrolled
Cullinan Oncology, LLCLead Sponsor
6 Previous Clinical Trials
642 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My liver, kidneys, and blood counts are healthy.You are currently struggling with drug or alcohol addiction.I am currently infected with COVID-19.I am 18 years old or older.I am not pregnant, breastfeeding, planning to become pregnant soon, and agree to use birth control during and after the study.My lung cancer is advanced and cannot be removed with surgery.My cancer has spread to my brain or its coverings.I have not taken part in a drug trial within the last 28 days or five half-lives of the drug.My treatment history matches the specific requirements for the trial's module.You had a severe allergic reaction to any part of the study drug CLN-619 or pembrolizumab in the past.I have more than one type of cancer.My cancer is advanced, cannot be surgically removed, and has been confirmed by lab tests.You understand and agree to the study's rules and requirements, and you sign a paper saying you agree to participate.Side effects from my previous cancer treatment are mild now.My bladder cancer cannot be removed by surgery and has spread.I finished my last palliative radiotherapy at least 14 days ago.My head or neck cancer cannot be removed by surgery and has spread.My NSCLC worsened after treatment with specific immune therapies or targeted therapies for EGFR or ALK mutations.I have taken immunosuppressive drugs within the last 28 days.My cervical cancer treatment did not necessarily include or exclude prior CPI therapy.I haven't had vaccines for infectious diseases like HPV in the last 28 days.The study is only open to people who are expected to live for at least 12 weeks.I've had severe side effects from immunotherapy, including nerve, eye, lung, heart, or colon issues, or serious liver problems.I am a male not planning to father a child or donate sperm during and for 120 days after the study.I haven't taken any antiviral, antibacterial, or antifungal medication for an infection in the last 7 days.My cancer is advanced, cannot be surgically removed, and for Module B, it's a type treatable with pembrolizumab.You have a medical condition that would make it difficult for you to receive the treatment planned for this study.I have NSCLC, HNSCC, or urothelial carcinoma.My lung cancer is advanced and cannot be removed with surgery.My cervical cancer is advanced and cannot be removed with surgery.I am fully active or restricted in physically strenuous activity but can do light work.You have a current autoimmune disease or have had one in the past.I have HIV or have tested positive for it.I have had hepatitis B or C in the past.I am not incapacitated or involuntarily incarcerated.I can follow the study plan and attend all required check-ups.I haven't had cancer treatment or major surgery in the last 28 days.My condition worsened 16 weeks after getting at least 3 doses of PD-1 therapy.I have either non-small cell lung cancer or cervical cancer.I have had an organ or bone marrow transplant from another person.
Research Study Groups:
This trial has the following groups:- Group 1: Module B Combination Therapy Cohort Expansion
- Group 2: Module A Cohort Expansion
- Group 3: Module B Combination Therapy Dose Escalation
- Group 4: Module A Dose Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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