A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive Solid Tumors

Launched by PIERRE FABRE MEDICAMENT · May 28, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called KIN-2787 for adults who have advanced solid tumors with specific genetic changes known as BRAF or NRAS mutations. The main goals of the trial are to see how safe the treatment is, how well it is tolerated by patients, how the body processes the medication, and to get an early idea of its effectiveness against certain types of cancer, including non-small cell lung cancer and melanoma.

To participate in this trial, patients must be adults with advanced solid tumors that have been confirmed to have the BRAF or NRAS mutations. They should be in good general health and able to take oral medications. Participants will receive the treatment and will be monitored closely for any side effects and their response to the therapy. It’s important for potential participants to know that certain health conditions, recent cancer treatments, or infections may exclude them from joining the study. If you're considering participating, you’ll need to provide written consent and meet specific health criteria outlined in the study.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• Exclusion Criteria:
• • 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.