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

PHASE1RECRUITING

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.

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Study details:

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, tolerability, and pharmacokinetics (PK) of KIN-2787, a RAF small molecule kinase inhibitor, to determine a recommended Phase 2 dose (RP2D) of KIN-2787, and to assess the objective response to KIN-2787 therapy alone and in combination with binimetinib, a mitogen-activated protein kinase (MEK) inhibitor. The dose expansion phase (Part B) will assess the safety and efficacy of KIN-2787 at the recommended dose and schedule in patients with cancers that contain BRAF Class I, II or III mutations, including lung cancer, melanoma, and other selected solid tumors.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2021-08-04

Primary completion: 2024-12-07

Study completion finish: 2025-12-01

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT04913285

Intervention or treatment

DRUG: KIN-2787

DRUG: KIN-2787 and binimetinib

Conditions

• Solid Tumor, Adult
• Non-small Cell Lung Cancer
• Melanoma

Condition: Solid Tumor, Adult, Non-small Cell Lung Cancer and more
DRUG: KIN-2787 and other drugs
Wollstonecraft, New South Wales, Australia and more
Sponsor: Pierre Fabre Medicament

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

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Find a site

Closest Location:

Melanoma Institute Australia

Research sites nearby

Select from list below to view details:

Melanoma Institute Australia
Wollstonecraft, New South Wales, Australia
Linear Clinical Research
Perth, Western Australia, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Dose Escalation Monotherapy (Part A1) Dose escalation of KIN-2787	DRUG: KIN-2787 KIN-2787 will be administered orally twice daily in 28-day cycles
EXPERIMENTAL: Dose Escalation Combination therapy (Part A2) Dose escalation of KIN-2787 and binimetinib	DRUG: KIN-2787 and binimetinib KIN-2787 and binimetinib will be administered orally twice daily in 28-day cycles
EXPERIMENTAL: Dose Expansion Monotherapy (Part B1) Dose expansion evaluating the recommended phase 2 dose (RP2D) of KIN-2787	DRUG: KIN-2787 KIN-2787 will be administered orally twice daily in 28-day cycles
EXPERIMENTAL: Dose Escalation Combination therapy (Part B2) Dose expansion evaluating the recommended phase 2 dose (RP2D) of KIN-2787 and binimetinib	DRUG: KIN-2787 and binimetinib KIN-2787 and binimetinib will be administered orally twice daily in 28-day cycles

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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.	Initiation of study drug through 28 days after last dose (up to approximately 18 months)
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.	Initiation of study drug through 28 days after last dose (up to approximately 18 months)
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	Initiation of study drug until disease progression (up to approximately 36 months)
In Part B (Dose Expansion) - disease control rate (DCR).	Not Specified	Initiation of study drug until disease progression (up to approximately 36 months)
In Part B (Dose Expansion) - duration of overall response (DOR).	Measure of clinical benefit, defined as the time from initial tumor response to documented tumor progression	Initiation of study drug until disease progression (up to approximately 36 months)
In Part B (Dose Expansion) - duration of stable disease.	Not Specified	Initiation of study drug until disease progression (up to approximately 36 months)

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Part A1 Dose Escalation: Characterization of PK properties and effect of food on PK of KIN-2787 including, but not limited to tmax.	Not Specified	Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Part A1 Dose Escalation: Characterization of PK properties and effect of food on PK of KIN-2787 including, but not limited to AUC.	Not Specified	Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Part A1 Dose Escalation: Characterization of PK properties and effect of food on PK of KIN-2787 including, but not limited to Cmax.	Not Specified	Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Part A2 Dose Escalation: characterization of PK properties of KIN-2787 and binimetinib in combination including, but not limited to Cmax.	Not Specified	Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Part A2 Dose Escalation: characterization of PK properties of KIN-2787 and binimetinib in combination including, but not limited to AUC.	Not Specified	Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Part A2 Dose Escalation: characterization of PK properties of KIN-2787 and binimetinib in combination including, but not limited to tmax.	Not Specified	Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Part B Dose Expansion: characterization of PK properties of KIN-2787, and for (B2) KIN-2787 + binimetinib including, but not limited to AUC.	Not Specified	Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Part B Dose Expansion: characterization of PK properties of KIN-2787, and for (B2) KIN-2787 + binimetinib including, but not limited to Cmax.	Not Specified	Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Part B Dose Expansion: characterization of PK properties of KIN-2787, and for (B2) KIN-2787 + binimetinib including, but not limited to tmax.	Not Specified	Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)

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References

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