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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 assessed up to approximately 1-3 years.
Awards & highlights
Study Summary
This trial tests a new cancer drug in patients with solid tumors. It checks safety & effectiveness.
Who is the study for?
This trial is for adults with various advanced cancers who've had standard treatment. They must be willing to use birth control and undergo biopsies. It's not for those with brain tumors, recent thrombosis, active pneumonitis, untreated brain metastases, autoimmune diseases, or a history of severe reactions to monoclonal antibodies.Check my eligibility
What is being tested?
CDX-585 is being tested in this study where all participants receive the drug openly without randomization. The trial aims to find the right dose and see how well it works across different types of advanced solid tumors.See study design
What are the potential side effects?
Potential side effects are not specified here but may include typical reactions related to immune therapies such as fatigue, skin reactions, digestive issues, and possible immune-related complications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed up to approximately 1-3 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed up to approximately 1-3 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: To determine the maximum tolerated dose of CDX-585 and to select the CDX-585 dose(s) for evaluation in tumor-specific expansion cohorts
Tumor-specific expansion cohorts: To further evaluate the safety of CDX-585 by tumor type.
Secondary outcome measures
Clinical Benefit Rate
Duration of Response
Immunogenicity Evaluation
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: CDX-585Experimental Treatment1 Intervention
Dose-escalation phase: Eligible patients will receive treatment, based on cohort assigned, in 2-week cycles until progression or intolerance.
Expansion phase: Patients enrolled in the expansion phase of the study will receive CDX-585 at the dose level chosen during the escalation phase.
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Who is running the clinical trial?
Celldex TherapeuticsLead Sponsor
61 Previous Clinical Trials
3,820 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had anti-PD-L1 therapy in the last 12 weeks or anti-PD-1 therapy in the last 4 weeks.I've been cancer-free for a year, except for minor skin cancers or in situ cancers.I have received standard treatment for my cancer in its advanced stages.I am willing to have biopsies before and during treatment if needed.I have an active autoimmune disease or a history of one.I have had or currently have lung inflammation not caused by an infection.I have been treated with more than one anti-PD-1 or anti-PD-L1 therapy.I have brain metastases that haven't been treated.I have never been treated with anti-ILT4 antibody.My cancer has returned, spread, or is very advanced, but it's not a brain tumor.I have not had blood clots in the past 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: CDX-585
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.
To what extent does CDX-585 present a hazard to patients?
"There is limited to no data that exists on the safety and efficacy of CDX-585, so it has been assigned a score of 1."
Answered by AI
Are candidates able to join this research endeavor at present?
"Affirmative. Clinicaltrials.gov verifies that this clinical trial, originally posted on May 11th 2023, is actively enrolling participants. At present, 130 patients from one location are needed to complete the study."
Answered by AI
What is the current participation rate of this clinical research?
"Correct. According to clinicaltrials.gov, this trial was first posted on May 11th 2023 and is still actively recruiting participants. The study requires 130 individuals from one site for full participation."
Answered by AI
What are the desired outcomes of this experiment?
"This clinical trial, which has a 6 month duration as its temporal parameter, intends to determine the maximum tolerated dose of CDX-585 and select it for further evaluation. The safety and tolerability of this drug will be assessed via CTCAE v5.0 while secondary objectives include evaluating overall survival patterns and the duration of response in patients who meet measure criteria."
Answered by AI
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