Solid Tumor, Adult study: KIN-2787 vs KIN-2787 and binimetinib
Official title A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive Solid Tumors
ClinicalTrials.gov ID: NCT04913285
What this study is testing
What is KIN-2787?
KIN-2787 is an investigational medicine, taken by mouth twice daily, being studied as a potential treatment for solid tumor, adult.
Also referred to as exarafenib.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether KIN-2787 is safe and how well it works. It also looks at how the body handles the drug.
- Who it's for
- You may be able to join if you are an adult with advanced solid tumors. Your cancer must have specific gene changes called BRAF or NRAS.
- What's involved
- You would take the study drug KIN-2787. You would also have regular check-ups and tests to monitor your health.
- Time commitment
- The source text does not specify the total length or number of visits.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provide written informed consent prior to initiation of any study-specific procedures.
- Metastatic or advanced stage solid tumor
- Known BRAF Class I, Class II, or Class III alteration or melanoma with an NRAS mutation as confirmed by previous genomic analysis of tumor tissue or...
- Measurable (Part A and B) or evaluable (Part A only) disease by RECIST v1.1.
- ECOG performance status 0-1
You likely can't join if
- Known participants who have received local therapy with either surgery and/or radiation therapy (participants with asymptomatic untreated brain...
- In Part B Dose Expansion, previous treatment with any approved or in-development small molecule BRAF-, MEK-, or MAPK-directed inhibitor therapy.
- GI tract disease causing an inability to take oral medication, malabsorption syndrome, requirement for intravenous alimentation, or uncontrolled...
- Active, uncontrolled bacterial, fungal, or viral infection.
- Participant with a positive test result for SARS-CoV2 infection, is known to have asymptomatic infection or is suspected of having SARS-CoV2, is...
- Women who are lactating or breastfeeding, or pregnant.
See the full eligibility criteria
- Provide written informed consent prior to initiation of any study-specific procedures.
- Metastatic or advanced stage solid tumor
- Known BRAF Class I, Class II, or Class III alteration or melanoma with an NRAS mutation as confirmed by previous genomic analysis of tumor tissue or ctDNA.
- Measurable (Part A and B) or evaluable (Part A only) disease by RECIST v1.1.
- ECOG performance status 0-1
- Adequate organ function, as measured by laboratory values (criteria listed in protocol).
- Able to swallow, retain, and absorb oral medications.
- Known participants who have received local therapy with either surgery and/or radiation therapy (participants with asymptomatic untreated brain metastasis may be eligible if met with certain criteria)
- In Part B Dose Expansion, previous treatment with any approved or in-development small molecule BRAF-, MEK-, or MAPK-directed inhibitor therapy.
- GI tract disease causing an inability to take oral medication, malabsorption syndrome, requirement for intravenous alimentation, or uncontrolled inflammatory GI disease.
- Active, uncontrolled bacterial, fungal, or viral infection.
- Participant with a positive test result for SARS-CoV2 infection, is known to have asymptomatic infection or is suspected of having SARS-CoV2, is excluded
- Women who are lactating or breastfeeding, or pregnant.
- Participants with any other active treated malignancy within 3 years prior to enrollment Complete inclusion and exclusion criteria are listed in the clinical study protocol.
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Denver, Colorado, United States
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- Rochester, Minnesota, United States
- Morristown, New Jersey, United States
- New Brunswick, New Jersey, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Nashville, Tennessee, United States
- Fairfax, Virginia, United States
- Waratah, New South Wales, Australia
- Wollstonecraft, New South Wales, Australia
- Southport, Queensland, Australia
- Heidelberg, Victoria, Australia
- Perth, Western Australia, Australia
- Haerbin, Heilongjiang, China
- Bordeaux, France
+ 21 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; San Diego, California, United States; San Francisco, California, United States; Denver, Colorado, United States; Jacksonville, Florida, United States; Orlando, Florida, United States and 35 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.