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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

Tracking Information
First Submitted Date  ICMJE May 18, 2021
First Posted Date  ICMJE June 4, 2021
Last Update Posted Date October 13, 2021
Actual Study Start Date  ICMJE August 4, 2021
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2021)
  • 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) ]
  • 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) ]
  • In Part B (dose expansion) - disease control rate (DCR). [ Time Frame: Initiation of study drug until disease progression (up to approximately 36 months) ]
  • 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
  • In Part B (dose expansion) - duration of stable disease. [ Time Frame: Initiation of study drug until disease progression (up to approximately 36 months) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2021)
  • 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) ]
  • 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) ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate KIN-2787 in Subjects With BRAF Mutation Positive Solid Tumors
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumor, Adult
  • Non-small Cell Lung Cancer
  • Melanoma
Intervention  ICMJE Drug: KIN-2787
KIN-2787 will be administered orally twice daily in 28-day cycles
Study Arms  ICMJE
  • Experimental: Dose Escalation
    Dose escalation of KIN-2787 in patients with solid tumors harboring Class I, Class II, or Class III BRAF alterations
    Intervention: Drug: KIN-2787
  • 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
    Intervention: Drug: KIN-2787
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 28, 2021)
115
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cynthia Voong +1 (619) 614-3663 cynthia.voong@kinnate.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04913285
Other Study ID Numbers  ICMJE KN-8701
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kinnate Biopharma
Study Sponsor  ICMJE Kinnate Biopharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kinnate Biopharma
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP