Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KIN-2787 | Drug | — | UNRESOLVED |
| KIN-2787 and binimetinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Dose Escalation Monotherapy (Part A1)
- description
- Dose escalation of KIN-2787
- interventionNames
- Drug: KIN-2787
- type
- EXPERIMENTAL
- label
- Dose Escalation Combination therapy (Part A2)
- description
- Dose escalation of KIN-2787 and binimetinib
- interventionNames
- Drug: KIN-2787 and binimetinib
- type
- EXPERIMENTAL
- label
- Dose Expansion Monotherapy (Part B1)
- description
- Dose expansion evaluating the recommended phase 2 dose (RP2D) of KIN-2787
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available