Informations générales (source: ClinicalTrials.gov)
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.
Interventional
Phase 1
Pierre Fabre Medicament (Voir sur ClinicalTrials)
août 2021
mars 2029
03 juillet 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | David PLANCHARD | 17/05/2024 14:31:28 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHM-CHU La Timone - Marseille - France | Caroline Gaudy | Contact (sur clinicalTrials) | |||
| Centre Leon Berard - Lyon - France | Philippe Cassier | Contact (sur clinicalTrials) | |||
| CHU Nantes-Hotel Dieu - Nantes - France | Stephanie Bordenave | Contact (sur clinicalTrials) | |||
| Institut Bergonie - Bordeaux - France | Antonie Italiano | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- 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.