©2024 Stanford Medicine
A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive Solid Tumors
Recruiting
I'm InterestedTrial ID: NCT04913285
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.
Stanford Investigator(s)
Christopher T Chen, MD
Assistant Professor of Medicine (Oncology)
Eligibility
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.
Intervention(s):
drug: KIN-2787
drug: KIN-2787 and binimetinib
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Aja Macias
+1 650-497-7499