NCT04913285RecruitingPhase 1
A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive Solid Tumors
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.
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 18 May 2021
- Start date
- 4 Aug 2021
- Primary completion date
- 30 Nov 2028
- Lead sponsor
- Pierre Fabre Medicament
- Diseases
- Melanoma, Lung cancer
- NCT number
- NCT04913285
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 400
- From 4 Aug 2021 to the primary completion date, 30 Nov 2028
- 48 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- 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
Other
- Women who are lactating or breastfeeding, or pregnant.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (48)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Austin Health Coordinator of this site? Confirm its status | Heidelberg | Australia | Recruiting |
| Linear Clinical Research Coordinator of this site? Confirm its status | Perth | Australia | Recruiting |
| Tasman Health Care Coordinator of this site? Confirm its status | Southport | Australia | Recruiting |
| Calvary Mater Hospital Newcastle Coordinator of this site? Confirm its status | Waratah | Australia | Recruiting |
| Melanoma Institute Australia Coordinator of this site? Confirm its status | Wollstonecraft | Australia | Recruiting |
| Beijing University Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Active, not recruiting |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Haerbin | China | Recruiting |
| LinYi Cancer Hospital Coordinator of this site? Confirm its status | Linyi | China | Active, not recruiting |
| The Shanghai Pulmonary Hospital Coordinator of this site? Confirm its status | Shanghai | China | Active, not recruiting |
| Arance Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Quiron Dexeus Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Insular de Gran Canaria Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Recruiting |
| START Madrid Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital General Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| NEXT Quirónsalud Madrid Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| H. Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| H. Virgen Macarena Coordinator of this site? Confirm its status | Seville | Spain | Recruiting |
| Berrocal Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| INCLIVA (Hospital Clinico de Valencia) Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Centre François Baclesse Coordinator of this site? Confirm its status | Caen | France | Recruiting |
| CHU de Lille Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| APHM-CHU La Timone Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| CHU Nantes-Hotel Dieu Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| CHU de Nice - Hôpital Archet 2 Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| APHP - Hôpital St Louis Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hospices Civiles de Lyon - Hôpital Lyon Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| CHU de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Recruiting |
| Oncopole Claudius Regaud Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| Istituto Nazionale dei Tumori Fondazione G. Pascale Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Active, not recruiting |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Sarah Cannon Research Institute Denver Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| Virginia Cancer Specialists Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| MD Anderson Coordinator of this site? Confirm its status | Houston | United States | Not yet recruiting |
| Mayo Clinic Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| UCLA Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| The Angeles Clinic Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Atlantic Health Coordinator of this site? Confirm its status | Morristown | United States | Recruiting |
| Sarah Cannon Research Institute (Tennessee Oncology) Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Rutgers Cancer Institute of New Jersey Coordinator of this site? Confirm its status | New Brunswick | United States | Recruiting |
| NYU Langone Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Sarah Cannon Research Institute - Florida Cancer Specialists Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Mayo Clinic - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| University of California San Diego Moores Cancer Center Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.