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NCT06179160 | RECRUITING | Solid Tumors

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

Incyte Corporation

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

Solid Tumors

Intervention/treatment

INCB161734

Cetuximab

Retifanlimab

GEMNabP

mFOLFIRINOX

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 466 participants
Masking : NONE
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 : 2024-01-04
Estimated Primary Completion Date : 2027-01-01
Estimated Study Completion Date : 2027-01-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * ≥18 years old
  • * Locally-advanced or metastatic solid tumor with KRAS G12D mutation
  • * For Part 1 and Part 2 Combination Groups 1 and 2: Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available standard treatment to improve the disease outcome
  • * For Part 2 Combination Groups 3 and 4: No more than 1 prior standard treatment
  • * Cohort specific requirements as follows
    • * Parts 1A and 1D: Histologically or cytologically confirmed malignant solid tumor of any tissue origin
    • * Part 1B
    • * Disease group 1: diagnosis of PDAC and ≤ 2 prior standard systemic regimens for pancreatic cancer
    • * 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 or 3
    • * Part 1c: Confirmed diagnosis of PDAC, CRC, or NSCLC
    • * Parts 2A and 2B
    • * Combination 1: Diagnosis of PDAC or Diagnosis of CRC and
    • * Prior treatment in the advanced setting with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan and
    • * In Part 2a: ≤ 3 prior standard regimens
    • * In Part 2b: ≤ 2 prior standard regimens
    • * Combination 2: Diagnoses of PDAC, CRC or NSCLC
    • * Combination Group 3 (INCB161734 in combination with GEMNabP) and Combination Group 4 (INCB161734 in combination with mFOLFIRINOX)
      • * Diagnosis of PDAC
      • * ≤ 1 prior standard systemic regimen for pancreatic cancer
      • * 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
A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

Location Details

NCT06179160

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Mayo Clinic Hospital

Phoenix, Arizona, United States, 85054

RECRUITING

United States, California

Stanford University

Palo Alto, California, United States, 94305

RECRUITING

United States, California

UCLA Healthcare Hematology-Oncology

Santa Monica, California, United States, 90404

RECRUITING

United States, Colorado

Sarah Cannon Research Institue At Healthone

Denver, Colorado, United States, 80218

NOT YET RECRUITING

United States, Maryland

Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

Baltimore, Maryland, United States, 21287

RECRUITING

United States, Massachusetts

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

RECRUITING

United States, New Jersey

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

RECRUITING

United States, New York

Weill Cornell Medicine

New York, New York, United States, 10021

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10022

NOT YET RECRUITING

United States, Tennessee

Scri Oncology Partners

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

Md Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

Australia, New South Wales

Chris Obrien Lifehouse

Camperdown, New South Wales, Australia, 02050

RECRUITING

Australia, New South Wales

St Vincent'S Hospital Sydney

Darlinghurst, New South Wales, Australia, 02010

RECRUITING

Australia, Victoria

The Alfred Hospital

Melbourne, Victoria, Australia, 03004

RECRUITING

Australia, Victoria

Peter Maccallum Cancer Centre

North Melbourne, Victoria, Australia, 3051

RECRUITING

Australia, Western Australia

Linear Clinical Research

Nedlands, Western Australia, Australia, 06009

RECRUITING

Belgium,

UCL Saint-Luc university clinics

Brussels, Belgium, 01200

RECRUITING

Belgium,

University Hospital Antwerp (UZA)

Edegem, Belgium, 02650

RECRUITING

Belgium,

University Hospital (UZ) Leuven

Leuven, Belgium, 03000

NOT YET RECRUITING

Canada, Ontario

The Ottawa Hospital Cancer Center

Ottawa, Ontario, Canada, K1h 8l6

RECRUITING

Canada, Ontario

Princess Margaret Cancer Center

Toronto, Ontario, Canada, M5G 2M9

RECRUITING

France,

Center Leon Berard

Lyon, France, 69373

RECRUITING

France,

Cancer academic from Toulouse Institut Claudius Regaud Iuct-Ocopole

Toulouse, France, 31059

RECRUITING

France,

Gustave Roussy Institute

Villejuif cedex, France, 94805

RECRUITING

Italy,

IRCCS Foundation National Cancer Institute

Milan, Italy, 20133

RECRUITING

Italy,

IRCCS Humanitas Clinical Institute

Rozzano, Italy, 20089

RECRUITING

Italy,

Clinical Research Center of Verona

Verona, Italy, 37134

RECRUITING

Japan,

National Cancer Center Hospital East

Chiba, Japan, 277-8577

RECRUITING

Japan,

The Cancer Institute Hospital of Jfcr

Small talk, Japan, 135-8550

RECRUITING

Spain,

Vall D Hebron University General Hospital

Barcelona, Spain, 08035

RECRUITING

Spain,

Jimenez Diaz Foundation

Madrid, Spain, 28040

RECRUITING

Spain,

Quironsalud Madrid University Hospital

Madrid, Spain, 28223