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INCB106385 + Immunotherapy for Cancer
Phase 1
Waitlist Available
Research Sponsored by Incyte Corporation
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 up to approximately 28 months
Awards & highlights
Study Summary
This trial is testing a new drug to treat cancer. The drug is given as monotherapy or in combination with another drug. The goal is to see if it is safe and effective.
Who is the study for?
This trial is for adults with certain advanced solid tumors that are CD8 T-cell-positive and have progressed after standard treatments. Participants must be in good physical condition (ECOG 0-1), have a life expectancy over 12 weeks, measurable disease, and agree to biopsies and contraception. Exclusions include recent vaccines, unmanaged immune-related toxicity or autoimmune diseases, active CNS metastases, other cancers within 2 years, unresolved treatment side effects, investigational drug use within recent weeks, significant heart issues or infections.Check my eligibility
What is being tested?
The study tests INCB106385 alone or combined with immunotherapy INCMGA00012 on various advanced cancers. It's an early-phase trial assessing safety and how the body processes these drugs (pharmacokinetics), their impact on the body (pharmacodynamics), and initial effectiveness at different doses.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system affecting organs due to increased activity against cancer cells but also possibly targeting normal tissue; infusion reactions; changes in blood counts; fatigue; gastrointestinal disturbances like nausea or diarrhea.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 28 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 28 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of treatment-emergent adverse events (TEAE)
Secondary outcome measures
AUC of INCB106385 as a single agent or in combination with INCMGA00012
CL/F of INCB106385 as a single agent or in combination with INCMGA00012
Change in immune cell activation in tumors
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Treatment Group B (TGB) - INCB106385+INCMGA00012Experimental Treatment2 Interventions
In part 1 dose escalation, the dose levels will be escalated following a BOIN design.
In part 2 dose expansion, participants will be assigned to different groups based on their tumor types and treated at the RDE.
Group II: Treatment Group A (TGA) - INCB106385Experimental Treatment1 Intervention
In part 1 dose escalation, the dose levels will be escalated following a BOIN design.
In part 2 dose expansion, participants will be assigned to different groups based on their tumor types and treated at the RDE.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INCB106385
2021
Completed Phase 1
~60
INCMGA00012
2021
Completed Phase 1
~60
Find a Location
Who is running the clinical trial?
Incyte CorporationLead Sponsor
364 Previous Clinical Trials
55,111 Total Patients Enrolled
Sven Gogov, M.DStudy DirectorIncyte Corporation
Ilona Rybicka, M.DStudy DirectorIncyte Corporation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You had serious side effects from a previous immune therapy that needed strong medication to treat.You have a weakened immune system or are taking steroids for a long time.You have cancer that has spread to the brain or the covering of the brain and spinal cord.You have another type of cancer that is getting worse or needs treatment, or you had a different type of cancer within the past 2 years.You have an autoimmune disease that needed medication for the past 2 years.You have not fully recovered from the side effects of previous treatment or surgery.You have a serious heart condition.You are taking strong medications that affect how other drugs work in your body.You have had to take strong antibiotics, antivirals, or antifungal medications for an infection within a week before starting the study treatment.You have a current infection or are at risk of reactivating hepatitis B or C.You have a history of lung disease or have lung inflammation.Your tumors have CD8 T-cells present.You have been diagnosed with HIV.You have had an organ or stem cell transplant in the past.You have a stomach or intestine problem that could make it hard for your body to absorb the drug.You have advanced or spreading cancer in the head and neck, lungs, ovaries, breasts, prostate, bladder, or specific types of stomach or bowel cancers that didn't get better with standard treatments.You have a disease that can be measured using specific guidelines.You are able to perform daily activities without any difficulty or with only a little difficulty.You are expected to live for at least 12 more weeks.Your lab test results are within normal ranges.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Group A (TGA) - INCB106385
- Group 2: Treatment Group B (TGB) - INCB106385+INCMGA00012
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study presently enrolling participants?
"This medical study is still open to recruitment, as evidenced by the current listing on clinicaltrials.gov. Initially posted in February 2021, this trial was last updated in November of 2022."
Answered by AI
Have there been additional investigations that have addressed the role of INCB106385?
"Initially researched in 2016 at Acibadem Cityclinica Mhat Tokuda, INCB106385 has since been subject to 7 completed trials. Currently, 26 experiments are actively recruiting participants; with many of these being conducted in New york City."
Answered by AI
Has this kind of research ever been conducted before?
"Since its inception in 2016, the Incyte Corporation has spearheaded research into INCB106385. After a successful Phase 1 trial involving 325 participants, 26 further trials are now live across 117 cities and 43 countries worldwide."
Answered by AI
Are there multiple sites in the US conducting this research?
"This medical trial is actively enrolling out of 8 distinct sites, including locations in New york, West Hollywood and Houston. To limit your travel needs if you join the study, we strongly recommend selecting a site near to you."
Answered by AI
Has the FDA sanctioned INCB106385 for use in medical treatments?
"As this is a Phase 1 trial and therefore lack substantial evidence of safety, INCB106385 was graded as having a Level 1 safety rating."
Answered by AI
How many participants have been enrolled in this research study?
"To adequately execute this trial, a total of 230 eligible patients need to be recruited. Potential participants can find locations in New york and California, such as Columbia University Medical Center in New York City or Cedars-Sinai Medical Center in West Hollywood."
Answered by AI
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