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A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06179160
Recruitment Status : Recruiting
First Posted : December 21, 2023
Last Update Posted : April 26, 2024
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Tracking Information
First Submitted Date  ICMJE December 12, 2023
First Posted Date  ICMJE December 21, 2023
Last Update Posted Date April 26, 2024
Actual Study Start Date  ICMJE January 4, 2024
Estimated Primary Completion Date January 1, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2023)
  • Number of participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 28 days ]
    Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.
  • Number of participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to 2 years and 90 days ]
    Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug monotherapy and in combination with cetuximab and retifanlimab.
  • Number of participants with TEAEs leading to dose modification or discontinuation [ Time Frame: Up to 2 years and 90 days ]
    Number of participants with TEAEs leading to dose modification or discontinuation.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2023)
  • INCB161734 pharmacokinetic (PK) in Plasma [ Time Frame: Up to approximately 90 days ]
    INCB161734 concentration in plasma.
  • Objective Response Rate (ORR) [ Time Frame: Up to 2 years ]
    Defined as having a best overall Complete Response (CR) or Partial Response (PR), as determined by the investigator by radiographic disease assessment according to RECIST v1.1.
  • Disease Control Response (DCR) [ Time Frame: Up to 2 years ]
    Defined as having a best overall response of CR, PR, or Stable Disease (SD) as determined by the investigator by radiographic disease assessment according to RECIST v1.1.
  • Duration of Response (DOR) [ Time Frame: Up to 2 years ]
    Defined as the time from earliest date of disease response (Completed Response or Partial Response) until earliest date of disease progression as determined by the investigator by radiographic disease assessment according to RECIST v1.1 or death due to any cause if occurring sooner than progression.
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 INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
Official Title  ICMJE A Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
Brief Summary This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.
Detailed Description Not Provided
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 Tumors
Intervention  ICMJE
  • Drug: INCB161734
    INCB161734 will be administered at protocol defined dose.
  • Drug: Cetuximab
    Cetuximab will be administered at protocol defined dose.
  • Drug: Retifanlimab
    Retifanlimab will be administered at protocol defined dose.
Study Arms  ICMJE
  • Experimental: Part 1a: Dose Escalation monotherapy
    INCB161734 at the protocol-defined dose strength based on cohort assignment.
    Intervention: Drug: INCB161734
  • Experimental: Part 1b: Dose Expansion monotherapy
    INCB161734 at the protocol-defined dose strength based on cohort assignment.
    Intervention: Drug: INCB161734
  • Experimental: Part 1c: Pharmacodynamic cohort
    INCB161734 at the protocol-defined dose strength based on cohort assignment.
    Intervention: Drug: INCB161734
  • Experimental: Part 2a: Dose Escalation combination
    INCB161734 in combination at the protocol-defined dose strength based on cohort assignment.
    Interventions:
    • Drug: INCB161734
    • Drug: Cetuximab
    • Drug: Retifanlimab
  • Experimental: Part 2b: Dose Expansion combination
    INCB161734 in combination at the protocol-defined dose strength based on cohort assignment.
    Interventions:
    • Drug: INCB161734
    • Drug: Cetuximab
    • Drug: Retifanlimab
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: December 20, 2023)		 322
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2027
Estimated Primary Completion Date January 1, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ≥18 years old
  • Locally-advanced or metastatic solid tumor with KRAS G12D mutation
  • Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available standard treatment to improve the disease outcome

  • Cohort specific requirements as follows:

    • Part 1A: Histologically or cytologically confirmed malignant solid tumor of any tissue origin

    • Part 1B

      • Disease group 1: diagnosis of PDAC
      • Disease group 2: diagnosis of CRC
      • Disease group 3: diagnosis of NSCLC
      • Disease group 4: diagnosis of other advanced solid tumor and not part of Disease groups 1, 2 and 3

    • Parts 2A and 2B

      • Combination 1: Diagnosis of CRC or CRC
      • Combination 2: Diagnoses of PDAC, CRC or NSCLC
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

  • Prior treatment with any KRAS G12D inhibitor
  • Known additional invasive malignancy within 1 year of the first dose of study drug
  • History of organ transplant, including allogeneic stem cell transplantation
  • Significant, uncontrolled medical condition
  • History or presence of an ECG abnormality
  • Inadequate organ function

Other protocol-defined Inclusion/Exclusion Criteria may apply
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: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 eumedinfo@incyte.com
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   France,   Italy,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06179160
Other Study ID Numbers  ICMJE INCB161734-101
2023-507091-47-00 ( Registry Identifier: EU CT Number )
Has Data Monitoring Committee Not Provided
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
Plan to Share IPD: No
Current Responsible Party Incyte Corporation
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Incyte Corporation
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Incyte Medical Monitor Incyte Corporation
PRS Account Incyte Corporation
Verification Date April 2024

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