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Study Summary
This trial is testing a new drug, INCB123667, to see if it is safe and effective in treating advanced or metastatic solid tumors. The trial will have two parts: in the first part, the doses of the drug will be gradually increased to find the best dose; in the second part, the drug will be given to people with different types of tumors to see how well it works.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am not taking any medications that are not allowed in the study.I have no other cancer needing treatment or that has been active in the last 2 years, except for certain skin cancers or other minor cancers treated over a year ago.My condition worsened after standard treatment, or I can't tolerate/have no other treatment options.I have been diagnosed with HIV.I am between 18 and 99 years old, living in France.I do not have severe liver disease or serious stomach/intestine problems.I am not on long-term antibiotics or antivirals for an infection.I am not currently on, nor have I recently taken, any experimental drugs.I have or had hepatitis B or C, but it's under control or cleared.I have not had major surgery in the last 28 days.I currently have or might have COVID-19.I am not pregnant or breastfeeding.I am currently on treatment for a chronic or active infection.I am fully active or can carry out light work.My cancer can be measured by scans but cannot be removed by surgery.I am not currently on, nor have I recently taken, strong medications that affect liver enzymes.I have untreated or worsening brain metastases.I haven't had radiation therapy in the last 28 days.I do not have serious heart conditions or uncontrolled high blood pressure.I haven't changed my hormone therapy or taken targeted cancer treatments recently.I have been treated with a CDK2 inhibitor before.I still have side effects from previous treatments or surgeries that are not mild.I can provide a sample of my tumor or am willing to have a biopsy.
- Group 1: Phase 1b: Dose Expansion Cohort Disease Group 4
- Group 2: Phase 1b: Dose Expansion Cohort Disease Group 5
- Group 3: Phase 1b: Dose Expansion Cohort Disease Group 6
- Group 4: Phase 1b: Dose Expansion Cohort Disease Group 1
- Group 5: Phase 1b: Dose Expansion Cohort Disease Group 2
- Group 6: Phase 1b: Dose Expansion Cohort Disease Group 3
- Group 7: Phase 1a Dose Escalation
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
How many Canadian healthcare sites are administering this research endeavor?
"This trial is currently being conducted at 14 distinct medical centres, such as those in Austin, Pittsburgh and Fort Worth. To reduce the burden of travelling for participants, it's important to select a clinic located nearby."
Are the eligibility requirements of this experiment open to those aged sixty and older?
"As per the study's inclusion criteria, any participant must be within the 18-99 age bracket. Specifically, there are 318 trials for minors and 2389 studies focusing on elderly patients."
Is this research endeavor currently recruiting participants?
"According to clinicaltrials.gov, this experiment is actively seeking participants and was uploaded on the 5th of July in 2022. The listing has been amended most recently on the 23rd of November that same year."
How many individuals are enrolled in this clinical trial at its peak capacity?
"Affirmative. Clinicaltrials.gov has data that suggests this medical trial is currently recruiting participants. The study was initially posted on July 5th 2022 and most recently edited on November 23rd 2022, with 155 people needed to be enrolled at 14 different sites."
Has the FDA granted a stamp of approval to INCB0123667?
"Due to the fact that INCB0123667 is currently only in a Phase 1 trial, it has garnered an approximate safety rating of one. This reflects the limited amount of evidence available thus far on its efficacy and risk-profile."
Is it possible to become a participant in this research endeavor?
"This clinical trial is enrolling 155 individuals suffering from cancer, ranging in age from 18 to 99. Eligibility criteria include the ability and willingness to avoid pregnancy or impregnation, life expectancy of longer than 12 weeks, ECOG performance status score no greater than 1, measurable lesions based on RECIST v1.1 that are not curative with surgery or other treatments, disease progression on prior standard treatment as well as availability of a baseline archival tumor specimen or agreement to undergo biopsies for sample collection."
What goals are researchers hoping to accomplish with this experiment?
"The sponsor of this trial, Incyte Corporation, has identified Number of Participants With Treatment Emergent Adverse Events (TEAEs) as the primary outcome to be monitored over a period spanning up to Day 28. Alongside the main objective, additional parameters such as PK Parameters: AUC [area under plasma concentration-time curve], PK Parameters: Ctau [concentration at dosing interval end] and Pk Parameters: Tmax[time until maximum plasma concentration] will also be measured."
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