Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive Solid Tumors
Lead Sponsor:
Pierre Fabre Medicament
Conditions:
Solid Tumor, Adult
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
This is a two-part, open-label, multi-center, dose escalation and dose expansion study in participants with BRAF mutation-positive and/or NRAS mutation-positive tumors designed to evaluate the safety,...
Eligibility Criteria
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
- Complete inclusion and exclusion criteria are listed in the clinical study protocol.
Key Trial Info
Start Date :
August 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2029
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04913285
Start Date
August 4 2021
End Date
March 30 2029
Last Update
December 24 2025
Active Locations (50)
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1
The Angeles Clinic
Los Angeles, California, United States, 90025-6602
2
UCLA
Los Angeles, California, United States, 90095
3
University of California San Diego, Moores Cancer Center
San Diego, California, United States, 92093
4
University of California San Francisco
San Francisco, California, United States, 94143-2205