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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 2 years
Awards & highlights
Study Summary
This trial tests a drug to see how safe and effective it is at treating advanced or metastatic solid tumors.
Who is the study for?
Adults with certain advanced or metastatic solid tumors who've had disease progression after standard treatments, including immunotherapies if applicable. They must have a good performance status, measurable disease, and be willing to undergo tumor biopsies. Exclusions include significant medical conditions, more than four prior cancer treatments for advanced disease, active infections or hepatitis/HIV, recent anticoagulation therapy changes.Check my eligibility
What is being tested?
The trial is testing the safety of a new drug called INCA33890 in patients with specific types of solid tumors. It aims to find the maximum tolerated dose and optimal dosing schedule by observing any dose-limiting toxicities that occur during treatment.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects for drugs like INCA33890 may include fatigue, nausea, diarrhea, skin reactions at injection sites and potential immune-related issues such as inflammation in various organs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with Dose Limiting Toxicities (DLTs)
Number of participants with TEAEs leading to dose modification or discontinuation
Number of participants with Treatment Emerging Adverse Events (TEAEs)
Secondary outcome measures
Disease Control Rate
Duration of Response
Objective response Rate
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Part 1b-Dose ExpansionExperimental Treatment1 Intervention
INCA33890 will be administered at the recommended dose(s) for expansion (RDE[s]) in participants with advanced or metastatic ICI sensitive or ICI non sensitive tumor types
Group II: Part 1a - Dose EscalationExperimental Treatment1 Intervention
INCA33890 will be administered at a protocol defined starting regimen intravenously. Subsequent dose regimens will be determined during study conduct.
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Who is running the clinical trial?
Incyte CorporationLead Sponsor
365 Previous Clinical Trials
55,130 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking more than 10 mg/day of prednisone or its equivalent.I am taking steroids for an autoimmune disease.I am not on long-term antibiotics or drugs for a chronic infection.I am 18 years old or older.I have a serious heart condition that is not under control.I do not have another cancer that is getting worse or needs treatment, nor have I had any other cancer in the last 2 years.My cancer is confirmed to be advanced or has spread to other parts.I have had an organ or stem cell transplant.I do not have serious heart or blood vessel problems.My cancer progressed after treatment, including immunotherapy, unless I couldn't tolerate it.I am fully active or can carry out light work.I am willing to have tumor biopsies before and during treatment.I have had more than 4 treatments for my advanced cancer.I haven't started or changed blood thinners in the last 3 months.I still have side effects from previous treatments that are not mild.My cancer has spread to my brain or CNS and is either untreated or getting worse.I have active hepatitis B, hepatitis C, or I am HIV positive.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1a - Dose Escalation
- Group 2: Part 1b-Dose Expansion
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.
Are there any available positions for this research trial?
"According to the clinicaltrials.gov database, this experiment is actively seeking candidates and was initially uploaded on July 24th 2023. The details were most recently revised on August 10th of that same year."
Answered by AI
What is the current capacity for enrolling subjects in this investigation?
"Incyte Corporation, the sponsor of this trial, requires 165 participants to meet its specific inclusion criteria. Participants can be enrolled at Hackensack University Medical Center in New jersey and Lifespan Cancer Research Institute in Rhode island amongst other medical centres."
Answered by AI
Has the initial phase of dose intensification in this trial received regulatory authorization from the FDA?
"Given the limited data associated with Phase 1 trials, we have assigned a score of 1 to part one-a's dose escalation in terms of safety."
Answered by AI
How many sites currently offer access to this trial?
"Potential participants in this clinical trial can be found at Hackensack University Medical Center in New jersey, Lifespan Cancer Research Institute in Rhode island, and the MD Anderson Cancer Centre of Texas. Additionally, there are 30 other sites recruiting for this study."
Answered by AI
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