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A Study to Evaluate KIN-2787 in Subjects With BRAF Mutation Positive Solid Tumors

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ClinicalTrials.gov Identifier: NCT04913285
Recruitment Status : Recruiting
First Posted : June 4, 2021
Last Update Posted : October 13, 2021
Sponsor:
Information provided by (Responsible Party):
Kinnate Biopharma

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-mutated advanced or metastatic solid tumors.

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Non-small Cell Lung Cancer Melanoma Drug: KIN-2787 Phase 1

Detailed Description:

BRAF, a gene that helps to control cell growth, is commonly altered in some cancers. BRAF alterations can be categorized into three classes based on their unique properties. Targeted therapies have been approved to treat certain types of cancers that harbor BRAF Class I mutations. However, there are currently no approved BRAF targeted therapies available for patients with tumors driven by Class II or Class III BRAF alterations

This study will evaluate the safety, pharmacokinetics (PK), and early clinical activity of KIN-2787, an experimental drug intended to target solid tumors harboring Class I, Class II, or Class III BRAF alterations.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/1b Open-Label, Multicenter, Two Part Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of KIN-2787 in Subjects With BRAF Mutation Positive Solid Tumors
Actual Study Start Date : August 4, 2021
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose Escalation
Dose escalation of KIN-2787 in patients with solid tumors harboring Class I, Class II, or Class III BRAF alterations
Drug: KIN-2787
KIN-2787 will be administered orally twice daily in 28-day cycles

Experimental: Dose Expansion
Dose expansion evaluating the recommended phase 2 dose (RP2D) of KIN-2787 in patients with NSCLC, melanoma, and other solid tumors harboring Class II or Class III BRAF alterations
Drug: KIN-2787
KIN-2787 will be administered orally twice daily in 28-day cycles




Primary Outcome Measures :
  1. Incidence of dose limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), and incidence of clinically significant changes in vital signs, physical examinations, ECGs, and clinical laboratory tests. [ Time Frame: Initiation of study drug through 28 days after last dose (up to approximately 18 months) ]
  2. In Part B (dose expansion) - objective response rate (ORR) using RECIST v1.1. [ Time Frame: Initiation of study drug until disease progression (up to approximately 36 months) ]
  3. In Part B (dose expansion) - disease control rate (DCR). [ Time Frame: Initiation of study drug until disease progression (up to approximately 36 months) ]
  4. In Part B (dose expansion) - duration of overall response (DOR). [ Time Frame: Initiation of study drug until disease progression (up to approximately 36 months) ]
    Measure of clinical benefit, defined as the time from initial tumor response to documented tumor progression

  5. In Part B (dose expansion) - duration of stable disease. [ Time Frame: Initiation of study drug until disease progression (up to approximately 36 months) ]

Secondary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) of KIN-2787 [ Time Frame: Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months) ]
  2. Time to achieve Cmax (Tmax) [ Time Frame: Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months) ]
  3. Area under the plasma concentration-time curve (AUC). [ Time Frame: Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 as confirmed by previous genomic analysis of tumor tissue or ctDNA.
  • Must have received prior standard therapy appropriate for the tumor type and stage of disease (including prior therapy with a BRAF inhibitor if FDA approved for the cancer type), OR unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy.
  • Measurable or evaluable disease by RECIST v1.1.
  • ECOG performance status 0, 1, or 2.
  • Adequate organ function, as measured by laboratory values (criteria listed in protocol).
  • Able to swallow, retain, and absorb oral medications.

Exclusion Criteria:

  • Known active brain metastases from non-brain tumors.
  • For tumor types and indications not approved by FDA, prior receipt of any 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.
  • Seropositive for hepatitis B or hepatitis C.
  • Women who are lactating or breastfeeding, or pregnant.
  • In Dose Expansion, patients with BRAF Class I mutations are excluded.

Complete inclusion and exclusion criteria are listed in the clinical study protocol.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04913285


Contacts
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Contact: Cynthia Voong +1 (619) 614-3663 cynthia.voong@kinnate.com

Locations
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United States, California
UCSD Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Julia Appelt, CCRC    858-822-0201    jappelt@health.ucsd.edu   
United States, Florida
Sarah Cannon Research Institute - Lake Nona Recruiting
Orlando, Florida, United States, 32827
Contact       asksarah@sarahcannon.com   
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact    844-482-4812      
United States, Virginia
Virginia Cancer Specialists Recruiting
Fairfax, Virginia, United States, 22031
Contact: Carrie Friedman, RN, BSN, OCN    703-636-1473    vcsclinicaltrials@usoncology.com   
Sponsors and Collaborators
Kinnate Biopharma
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Responsible Party: Kinnate Biopharma
ClinicalTrials.gov Identifier: NCT04913285    
Other Study ID Numbers: KN-8701
First Posted: June 4, 2021    Key Record Dates
Last Update Posted: October 13, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kinnate Biopharma:
BRAF inhibitor
BRAF
pan-RAF
pan-RAF inhibitor
RAF1
ARAF
BRAF alteration
BRAF Class II
BRAF Class III
V600
tumor growth inhibitor (TGI)
melanoma
NSCLC
solid tumor
targeted therapy
BRAF Class I
Additional relevant MeSH terms:
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Melanoma
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas