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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04913285




Registration number
NCT04913285
Ethics application status
Date submitted
18/05/2021
Date registered
4/06/2021
Date last updated
29/05/2024

Titles & IDs
Public title
A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive Solid Tumors
Scientific title
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.
Secondary ID [1] 0 0
KIN 2787CI101
Secondary ID [2] 0 0
KN-8701
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumor, Adult 0 0
Non-small Cell Lung Cancer 0 0
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - KIN-2787
Treatment: Drugs - KIN-2787 and binimetinib

Experimental: Dose Escalation Monotherapy (Part A1) - Dose escalation of KIN-2787

Experimental: Dose Escalation Combination therapy (Part A2) - Dose escalation of KIN-2787 and binimetinib

Experimental: Dose Expansion Monotherapy (Part B1) - Dose expansion evaluating the recommended phase 2 dose (RP2D) of KIN-2787

Experimental: Dose Escalation Combination therapy (Part B2) - Dose expansion evaluating the recommended phase 2 dose (RP2D) of KIN-2787 and binimetinib


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

Treatment: Drugs: KIN-2787 and binimetinib
KIN-2787 and binimetinib will be administered orally twice daily in 28-day cycles
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A1 Dose escalation monotherapy:
Timepoint [1] 0 0
Initiation of study drug through 28 days after last dose (up to approximately 18 months)
Primary outcome [2] 0 0
Part A2 Dose Escalation: KIN-2787 + Binimetinib Combination
Timepoint [2] 0 0
Initiation of study drug through 28 days after last dose (up to approximately 18 months)
Primary outcome [3] 0 0
In Part B (Dose Expansion) - objective response rate (ORR) using RECIST v1.1.
Timepoint [3] 0 0
Initiation of study drug until disease progression (up to approximately 36 months)
Primary outcome [4] 0 0
In Part B (Dose Expansion) - disease control rate (DCR).
Timepoint [4] 0 0
Initiation of study drug until disease progression (up to approximately 36 months)
Primary outcome [5] 0 0
In Part B (Dose Expansion) - duration of overall response (DOR).
Timepoint [5] 0 0
Initiation of study drug until disease progression (up to approximately 36 months)
Primary outcome [6] 0 0
In Part B (Dose Expansion) - duration of stable disease.
Timepoint [6] 0 0
Initiation of study drug until disease progression (up to approximately 36 months)
Secondary outcome [1] 0 0
Part A1 Dose Escalation: Characterization of PK properties and effect of food on PK of KIN-2787 including, but not limited to tmax.
Timepoint [1] 0 0
Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Secondary outcome [2] 0 0
Part A1 Dose Escalation: Characterization of PK properties and effect of food on PK of KIN-2787 including, but not limited to AUC.
Timepoint [2] 0 0
Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Secondary outcome [3] 0 0
Part A1 Dose Escalation: Characterization of PK properties and effect of food on PK of KIN-2787 including, but not limited to Cmax.
Timepoint [3] 0 0
Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Secondary outcome [4] 0 0
Part A2 Dose Escalation: characterization of PK properties of KIN-2787 and binimetinib in combination including, but not limited to Cmax.
Timepoint [4] 0 0
Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Secondary outcome [5] 0 0
Part A2 Dose Escalation: characterization of PK properties of KIN-2787 and binimetinib in combination including, but not limited to AUC.
Timepoint [5] 0 0
Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Secondary outcome [6] 0 0
Part A2 Dose Escalation: characterization of PK properties of KIN-2787 and binimetinib in combination including, but not limited to tmax.
Timepoint [6] 0 0
Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Secondary outcome [7] 0 0
Part B Dose Expansion: characterization of PK properties of KIN-2787, and for (B2) KIN-2787 + binimetinib including, but not limited to AUC.
Timepoint [7] 0 0
Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Secondary outcome [8] 0 0
Part B Dose Expansion: characterization of PK properties of KIN-2787, and for (B2) KIN-2787 + binimetinib including, but not limited to Cmax.
Timepoint [8] 0 0
Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Secondary outcome [9] 0 0
Part B Dose Expansion: characterization of PK properties of KIN-2787, and for (B2) KIN-2787 + binimetinib including, but not limited to tmax.
Timepoint [9] 0 0
Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Melanoma Institute Australia - Wollstonecraft
Recruitment hospital [2] 0 0
Linear Clinical Research - Perth
Recruitment postcode(s) [1] 0 0
2065 - Wollstonecraft
Recruitment postcode(s) [2] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
China
State/province [11] 0 0
Hubei
Country [12] 0 0
China
State/province [12] 0 0
Shandong
Country [13] 0 0
China
State/province [13] 0 0
Beijing
Country [14] 0 0
China
State/province [14] 0 0
Shanghai
Country [15] 0 0
France
State/province [15] 0 0
Bordeaux
Country [16] 0 0
France
State/province [16] 0 0
Lyon
Country [17] 0 0
France
State/province [17] 0 0
Marseille
Country [18] 0 0
France
State/province [18] 0 0
Nantes
Country [19] 0 0
France
State/province [19] 0 0
Villejuif
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Cheongju-si
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Seoul
Country [22] 0 0
Netherlands
State/province [22] 0 0
Amsterdam
Country [23] 0 0
Spain
State/province [23] 0 0
Barcelona
Country [24] 0 0
Spain
State/province [24] 0 0
Las Palmas De Gran Canaria
Country [25] 0 0
Spain
State/province [25] 0 0
Madrid
Country [26] 0 0
Spain
State/province [26] 0 0
Valencia
Country [27] 0 0
Taiwan
State/province [27] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pierre Fabre Medicament
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04913285
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kinnate Clinical Operations
Address 0 0
Country 0 0
Phone 0 0
858.252.2723
Fax 0 0
Email 0 0
clinicaltrials@kinnate.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04913285