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A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive Solid Tumors

ConditionsSolid Tumor, AdultNon-small Cell Lung CancerMelanoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPierre Fabre Medicament

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • KIN-2787

    Drug

    KIN-2787 will be administered orally twice daily in 28-day cycles

  • KIN-2787 and binimetinib

    Drug

    Continuous and Ramp-Up cohorts: KIN-2787 (exarafenib) and binimetinib will be administered orally twice daily in 28-day cycles Intermittent Cohort: KIN-2787 will be administered orally twice daily and binimetinib will be administered twice daily for 5 days on, 2 days off for 28-day cycles

Treatment groups

400 Participants
are divided into 4 treatment groups
Group A: Dose Escalation Monotherapy (Part A1)Experimental treatment 1 intervention
Group B: Dose Escalation Combination therapy (Part A2)Experimental treatment 1 intervention
Group C: Dose Expansion Monotherapy (Part B1)Experimental treatment 1 intervention
Group D: Dose Escalation Combination therapy (Part B2)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part A1 Dose escalation monotherapy:

To determine the safety and tolerability of oral administration of KIN-2787 including dose-limiting toxicities (DLTs), and to identify the maximum tolerated dose (MTD) and/or the appropriate dose for further clinical investigation in Part B Dose Expansion.

Time frame
Initiation of study drug through 28 days after last dose (up to approximately 18 months)
2

Part A2 Dose Escalation: KIN-2787 + Binimetinib Combination

To determine the safety and tolerability of oral administration of KIN-2787 + binimetinib including DLTs, and to identify the MTD and/or the appropriate dose for further clinical investigation.

Time frame
Initiation of study drug through 28 days after last dose (up to approximately 18 months)
3

In Part B (Dose Expansion) - objective response rate (ORR) using RECIST v1.1.

To assess preliminary evidence of the anti-cancer activity of KIN-2787 and for (B2) KIN-2787 + binimetinib

Time frame
Initiation of study drug until disease progression (up to approximately 36 months)
4

In Part B (Dose Expansion) - disease control rate (DCR).

Time frame
Initiation of study drug until disease progression (up to approximately 36 months)

Secondary outcomes

1

Part A1 Dose Escalation: Characterization of PK properties and effect of food on PK of KIN-2787 including, but not limited to tmax.

Time frame
Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
2

Part A1 Dose Escalation: Characterization of PK properties and effect of food on PK of KIN-2787 including, but not limited to AUC.

Time frame
Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
3

Part A1 Dose Escalation: Characterization of PK properties and effect of food on PK of KIN-2787 including, but not limited to Cmax.

Time frame
Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
4

Part A2 Dose Escalation: characterization of PK properties of KIN-2787 and binimetinib in combination including, but not limited to Cmax.

Time frame
Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pierre Fabre Medicament

Lead sponsor

Source ClinicalTrials.gov
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