This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: INCB161734 Drug: Cetuximab Drug: Retifanlimab Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 322 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
Actual Study Start Date : January 4, 2024
Estimated Primary Completion Date : January 1, 2027
Estimated Study Completion Date : January 1, 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Part 1a: Dose Escalation monotherapy
INCB161734 at the protocol-defined dose strength based on cohort assignment.
 Drug: INCB161734
INCB161734 will be administered at protocol defined dose.
Experimental: Part 1b: Dose Expansion monotherapy
INCB161734 at the protocol-defined dose strength based on cohort assignment.
 Drug: INCB161734
INCB161734 will be administered at protocol defined dose.
Experimental: Part 1c: Pharmacodynamic cohort
INCB161734 at the protocol-defined dose strength based on cohort assignment.
 Drug: INCB161734
INCB161734 will be administered at protocol defined dose.
Experimental: Part 2a: Dose Escalation combination
INCB161734 in combination at the protocol-defined dose strength based on cohort assignment.
 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.
Experimental: Part 2b: Dose Expansion combination
INCB161734 in combination at the protocol-defined dose strength based on cohort assignment.
 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. INCB161734 pharmacokinetic (PK) in Plasma [ Time Frame: Up to approximately 90 days ]
    INCB161734 concentration in plasma.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT06179160


Contacts
Layout table for location contacts
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

Locations
Show Show 19 study locations
Sponsors and Collaborators
Incyte Corporation
Investigators
Layout table for investigator information
Study Director: Incyte Medical Monitor Incyte Corporation
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT06179160    
Other Study ID Numbers: INCB161734-101
2023-507091-47-00 ( Registry Identifier: EU CT Number )
First Posted: December 21, 2023    Key Record Dates
Last Update Posted: April 26, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
INCB161734
KRASG12D Mutation
pancreatic ductal adenocarcinoma (PDAC)
colorectal cancer (CRC)
non-small cell lung cancer (NSCLC)
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents