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CLN-617 + Pembrolizumab for Solid Tumors

Phase 1

Recruiting

Research Sponsored by Cullinan Therapeutics Inc.

Eligibility Criteria Checklist

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

Must have

Aged ≥ 18 years

Part 1 Dose Escalation Cohorts: Histologically or cytologically confirmed advanced incurable or metastatic non-neurological solid tumor with accessible injectable lesions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial studies an experimental drug (CLN-617) in combo with pembrolizumab to treat advanced solid tumors. It's a Phase 1 study.

Who is the study for?

Adults (18+) with advanced solid tumors who have measurable lesions, appropriate for pembrolizumab treatment, and a life expectancy of at least 12 weeks. They must have normal organ function, resolved prior therapy toxicities to Grade 1 or stable Grade 2, except alopecia. Excludes those with uncontrolled diseases like heart issues or diabetes, active infections including HIV/Hepatitis B/C and COVID-19, recent immunosuppressive treatments or cancer therapies.Check my eligibility

What is being tested?

The trial is testing CLN-617 alone and combined with Pembrolizumab in patients with advanced solid tumors. It's an early-phase study that includes dose escalation to find the safest dose that works best before expanding to more patients.See study design

What are the potential side effects?

Potential side effects may include typical reactions from immunotherapy such as fatigue, skin reactions, inflammation in organs like the liver or lungs; also possible are infusion-related reactions due to the drugs being administered into the bloodstream.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have an advanced cancer that cannot be cured and can be injected for treatment.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My liver, kidneys, and blood counts are within the normal range.

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My liver enzymes are within the required range.

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My kidneys are functioning well enough, with a creatinine clearance rate of at least 50 mL/min.

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My white blood cell count is healthy without needing medication to boost it.

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My advanced cancer is confirmed and has a tumor that can be injected.

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My head or neck cancer is advanced, cannot be surgically removed, and has a tumor that can be injected.

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My tumor can be felt, seen on ultrasound, and safely injected.

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I have advanced melanoma that cannot be surgically removed and has lesions that can be injected.

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My hemoglobin level is at least 8 g/dL without recent blood transfusions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

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

Dose Optimization

Secondary outcome measures

All Cohorts

Trial Design

3Treatment groups

Experimental Treatment

Group I: CLN-617 Dose Optimization (Part B)Experimental Treatment2 Interventions

Patients with Advanced Solid Tumors enrolled in dose optimization receiving selected doses of CLN-617 in combination with pembrolizumab

Group II: CLN-617 Dose Expansion (Part C)Experimental Treatment2 Interventions

Patients with Advanced Melanoma or Head and Neck Squamous Cell Carcinoma (HNSCC) enrolled in dose expansion treated with CLN-617 in combination with pembrolizumab

Group III: CLN-617 Dose Escalation (Part A)Experimental Treatment2 Interventions

Patients with Advanced Solid Tumors enrolled in dose escalation cohorts treated with CLN-617 alone and in combination with pembrolizumab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cullinan Therapeutics Inc.Lead Sponsor

6 Previous Clinical Trials

712 Total Patients Enrolled

Cullinan Oncology, LLCLead Sponsor

6 Previous Clinical Trials

966 Total Patients Enrolled

Cullinan Oncology Inc.Lead Sponsor

5 Previous Clinical Trials

682 Total Patients Enrolled

Frequently Asked Questions

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

What potential hazards might participants in the CLN-617 Dose Escalation (Part A) trials face?

"The safety and efficacy of CLN-617 Dose Escalation (Part A) has not been thoroughly established yet, thus it was assigned a score of 1."

Answered by AI

What is the geographical span of this research project?

"This experiment is recruiting at 6 various sites, which are located in Orlando, Chicago and Houston among other locations. Patients should consider the proximity of a medical centre to decrease travel needs if they decide to participate."

Answered by AI

Are participants being accepted for the trial currently?

"According to the clinicaltrials.gov website, this particular trial is no longer searching for participants. The posting was initially uploaded on September 1st 2023 and it's most recent update occured around a month later on September 12th of that same year. Despite not being able to join this research study, there are presently 2694 other trials actively recruiting volunteers at present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CLN-617 Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors

2023. "CLN-617 Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06035744.