Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
This study is looking at how safe and how well tolerated a targeted drug KIN-2787 (exarafenib) is alone and in combination with another drug (binimetinib) by people with BRAF/NRAS-mutated advanced or metastatic solid cancers.
The study will be divided into two parts. In part A, first group of eligible participants will be given KIN-2787 orally twice daily in 28-day treatment cycles. Second group will be given a combination of KIN-2787 and binimetinib. KIN-2787 will be administered orally twice daily in 28-day cycles and binimetinib will be administered twice daily for 5 days on, 2 days off for 28-day cycles. In part A treatment will be given in increasing doses.
In part B, first group will be given KIN-2787, orally twice daily in 28-day cycles. Second group will recieve a combination of KIN-2787 (exarafenib) and binimetinib. KIN-2787 will be administered orally twice daily in 28-day cycles and binimetinib will be administered twice daily for 5 days on, 2 days off for 28-day cycles. The dose of drugs used in part B will be determined by the results of part A.
Conditions
This trial is treating people with BRAF/NRAS-mutated advanced or metastatic solid cancers, including non-small cell lung cancer, melanoma and other cancers
Eligibility
Inclusion
- 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.
Exclusion
- 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
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- You are able to swallow medication by mouth.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Pierre Fabre Medicament
Scientific Title
A Phase 1/1b Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of KIN-2787 in Participants With BRAF and/or NRAS Mutation-positive Solid Tumors.
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information