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CAR T-cell Therapy
IDE196 Combinations for Solid Tumors
Phase 1 & 2
Recruiting
Research Sponsored by IDEAYA Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must be ≥18 years of age
History of syncope
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approx. 48 months
Awards & highlights
Study Summary
This trial is testing the safety and effectiveness of a new drug, IDE196, for patients with solid tumors that have a specific gene mutation. The trial has three parts. First, they will test different doses of the drug to see what is safe and what the side effects are. Second, they will test the drug combination with binimetinib to see if it is effective and has any new side effects. Third, they will test the drug combination with crizotinib to see if it is effective and has any new side effects.
Who is the study for?
This trial is for adults with certain solid tumors, including metastatic uveal melanoma, skin cancer, and colorectal cancer that have specific genetic mutations or fusions. Participants must have had prior treatment with a MEK inhibitor (except for Binimetinib Combination), measurable disease, good performance status (ECOG ≤1), life expectancy over 3 months, adequate organ function and cardiac function (for Binimetinib Combination), and agree to use contraception. Exclusions include symptomatic brain metastases, pregnancy/breastfeeding women, recent thromboembolic events or surgeries.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of IDE196 alone or in combination with Crizotinib or Binimetinib in patients whose tumors have GNAQ/11 mutations or PRKC fusions. It includes dose escalation to find the right amount of drug and then expands to more patients at this dose. The effects of food on IDE196's absorption are also studied.See study design
What are the potential side effects?
Potential side effects may include issues related to liver function changes due to IDE196; heart problems from Binimetinib; lung issues like pneumonitis from both drugs; vision changes such as retinal vein occlusion from Binimetinib; muscle pain/inflammation due to elevated CPK levels from Binimetinib.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have a history of fainting.
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I have spinal cord compression.
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I have melanoma or another solid tumor with a specific mutation and it has worsened after treatment.
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My heart pumps well, with an ejection fraction of 50% or higher.
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I can perform daily activities with minimal help and am expected to live more than 3 months.
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I have had pneumonitis or lung disease affecting the tissue and space around the air sacs.
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I finished any previous cancer treatments or major surgeries at least 4 weeks ago.
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I have been treated with a MEK inhibitor before.
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I have a history of lung scarring or fibrosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approx. 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approx. 48 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose-limiting Toxicity (DLT)
Duration of Response for combination with Binimetinib or in combination with Crizotinib Dose Expansion by Blinded Independent Review Committee
Maximum Tolerated Dose (MTD)
+5 moreSecondary outcome measures
Disease Control by Investigator
Duration of Response by Investigator
Duration of Response for combination with Binimetinib or in combination with Crizotinib in Dose Escalation and in all combination cohorts by Blinded Independent Review Committee
+4 moreOther outcome measures
Overall Survival
Progression-Free Survival
Reduction in tumor burden by total volumetric measurement
+2 moreTrial Design
9Treatment groups
Experimental Treatment
Group I: Tablet PK SubstudyExperimental Treatment1 Intervention
IDE196 dosed orally, once on Cycle 1 Day 1; thereafter, twice daily (BID) for each 28-day cycle
Group II: Dose Optimization Crizotinib CombinationExperimental Treatment2 Interventions
IDE196 dosed orally, twice daily (BID) for each 28-day cycle and Crizotinib dosed orally, twice daily (BID) for each 28-day cycle
Group III: Dose Expansion MonotherapyExperimental Treatment1 Intervention
RP2D in MUM and non-MUM tumors harboring GNAQ/11 mutations or PRKC fusions (cutaneous melanoma, CRC, other solid tumors)
Group IV: Dose Expansion Crizotinib CombinationExperimental Treatment2 Interventions
RP2D in MUM and non-MUM tumors harboring GNAQ/11 mutations (cutaneous melanoma, CRC, other solid tumors)
Group V: Dose Expansion Binimetinib CombinationExperimental Treatment2 Interventions
RP2D in MUM and non-MUM tumors harboring GNAQ/11 mutations (cutaneous melanoma, CRC, other solid tumors)
Group VI: Dose Escalation MonotherapyExperimental Treatment1 Intervention
IDE196 dosed orally, twice daily (BID) for each 28-day cycle
Group VII: Dose Escalation Crizotinib CombinationExperimental Treatment2 Interventions
IDE196 dosed orally, twice daily (BID) for each 28-day cycle and Crizotinib dosed orally, twice daily (BID) for each 28-day cycle
Group VIII: Dose Escalation Binimetinib CombinationExperimental Treatment2 Interventions
IDE196 dosed orally, twice daily (BID) for each 28-day cycle and Binimetinib dosed orally, twice daily (BID) for each 28-day cycle
Group IX: Crizotinib Monotherapy with Crossover to CombinationExperimental Treatment2 Interventions
Crizotinib dosed orally, twice daily (BID) for each 28-day cycle until disease progression then IDE196 added and dosed orally, twice daily (BID) for each 28-day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Crizotinib
2014
Completed Phase 3
~2370
Binimetinib
2018
Completed Phase 3
~1100
Find a Location
Who is running the clinical trial?
IDEAYA BiosciencesLead Sponsor
4 Previous Clinical Trials
660 Total Patients Enrolled
Jasgit Sachdev, MDStudy Directorjsachdev@ideayabio.com
3 Previous Clinical Trials
237 Total Patients Enrolled
Matthew Maurer, MDStudy Directormmaurer@ideayabio.com
3 Previous Clinical Trials
510 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously been treated with a MEK inhibitor.I am 18 years old or older.I have a muscle disorder that increases my CPK levels.I have a history of fainting.I have a history of fainting.My organs are working well.I am not on any medications that can't be stopped for the study.I have had surgery to remove my stomach or part of my upper bowel, or I have another significant digestive system condition.My tumor is MSI-H/dMMR and I haven't had immune checkpoint inhibitors.I do not have AIDS, hepatitis B, or hepatitis C.I have brain metastases that are causing symptoms.I have had surgery or radiotherapy recently.I have spinal cord compression.I have been treated with a PKC inhibitor before.I still have side effects from previous cancer treatments.I am not allergic to mammalian meat products or gelatin.My high blood pressure is not controlled by medication.I have melanoma or another solid tumor with a specific mutation and it has worsened after treatment.My heart pumps well, with an ejection fraction of 50% or higher.I have mild or no nerve damage before starting crizotinib treatment.I can perform daily activities with minimal help and am expected to live more than 3 months.I have a history of fainting.I haven't had a stroke or blood clot in the last 3 months.I have had pneumonitis or lung disease affecting the tissue and space around the air sacs.I have spinal cord compression.I have no history or current signs of retinal vein occlusion.I am not allergic to binimetinib or its components.I have received treatments targeting ALK, MET, or ROS1.I finished any previous cancer treatments or major surgeries at least 4 weeks ago.I have been treated with a MEK inhibitor before.I have a history of lung scarring or fibrosis.I have had pneumonitis or lung disease.My heart does not function properly.I am not pregnant or breastfeeding.You have a disease that can be measured or tracked for changes.I have a history of lung scarring or fibrosis.I am currently being treated for an infection.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation Crizotinib Combination
- Group 2: Dose Expansion Crizotinib Combination
- Group 3: Dose Optimization Crizotinib Combination
- Group 4: Crizotinib Monotherapy with Crossover to Combination
- Group 5: Dose Escalation Monotherapy
- Group 6: Dose Expansion Monotherapy
- Group 7: Dose Escalation Binimetinib Combination
- Group 8: Dose Expansion Binimetinib Combination
- Group 9: Tablet PK Substudy
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.
Uveal Melanoma Patient Testimony for trial: Trial Name: NCT03947385 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has research been conducted on IDE196 in the past?
"Presently, 88 clinical trials are being conducted to research the efficacy of IDE196. Of those studies, 9 have progressed into Phase 3 while 8500+ sites all over the world are working on related investigations. The epicentre for these experiments is located in Bluffton, South carolina."
Answered by AI
Are there still enrollments open for this trial?
"This trial is still recruiting participants, as stated on clinicaltrials.gov; which reported the original posting date of June 28th 2019 and a most recent update being May 10th 2022."
Answered by AI
Does this experiment break with traditional research protocols?
"Presently, there are 88 ongoing clinical trials for IDE196 in 47 nations and 1408 towns. Pfizer commenced the initial trial of this medication back in 2011 with 44 patients that completed Phase 1 approval. Since then, 67 further studies have been conducted."
Answered by AI
What are the principal aims of this investigation?
"This clinical trial spans 28 days post initial dose of IDE196. The primary objective is to identify the Recommended Phase 2 Dose for monotherapy, in combination with Binimetinib, or used together with Crizotinib. Secondary metrics that will be assessed by Blinded Independent Review Committee (RECIST v1.1) include Duration of Response, Overall Response Rate and Disease Control as determined by Investigator's RECIST version 1.1 criteria."
Answered by AI
What is the upper limit of participants for this experiment?
"Affirmative. The clinicaltrial.gov database confirms that this research trial is presently recruiting participants, having been initially posted on June 28th 2019 and edited just recently on May 10th 2022. A total of 254 patients are being sought from 13 different sites for the study."
Answered by AI
In which geographical areas can individuals access this clinical trial?
"This research endeavor is being conducted at Mosaic Life Care in Saint Joseph, Missouri, San Francisco Oncology Associates in California, and Duke University Medical Centre located in Durham, Ontario. In addition to these 3 sites, there are 13 other similar locations involved."
Answered by AI
In what medical conditions is IDE196 typically employed?
"IDE196 is most frequently utilized for the treatment of metastatic melanoma, but can also be deployed against malignant neoplasms and unresectable melanoma with BRAF V600K mutation."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
What questions have other patients asked about this trial?
What is the process? Would I have to go off all treatments? What happens if I’m in trial and it shows disease progression? Is there stays involved?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
I have tried Gem/cis/imfinzi/zometa in which I did my schedule of treatments to be taken off gem/cis and left on imfinzi/zometa and on my last pet scan to show disease progression. I have cholangiocarcinoma with Mets to lung, bone & lymph nodes.
PatientReceived no prior treatments
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