Trial Review

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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04913285
Ethics application status
Date submitted
18/05/2021
Date registered
4/06/2021
Date last updated
12/07/2024

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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
CLaire FABRE, MD
Address 0 0
Pierre Fabre Laboratories
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Claire Fabre, MD
Address 0 0
Country 0 0
Phone 0 0
+33534506059
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04913285