A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive Solid Tumors
Trial ID or NCT#
NCT04913285
Status
RECRUITING
Purpose
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-2787 in adults with BRAF/NRAS-mutated advanced or metastatic solid tumors.
Official 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.
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Aja Macias
+1 650-497-7499
View on ClinicalTrials.gov
