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

Solid Tumors Clinical Trial

Official title:

A Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06179160
• Other study ID #: INCB161734-101
• Secondary ID: 2023-507091-47-0
• Status: Recruiting
• Phase: Phase 1
• Start date: January 4, 2024
• Est. completion date: January 1, 2027

Study information

• Verified date: June 2024
• Source: Incyte Corporation
• Contact: Incyte Corporation Call Center (US)
• Phone: 1.855.463.3463
• Email: medinfo[@]incyte.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 322
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumors

Intervention

Drug:
• INCB161734
INCB161734 will be administered at protocol defined dose.
• Cetuximab
Cetuximab will be administered at protocol defined dose.
• Retifanlimab
Retifanlimab will be administered at protocol defined dose.

Locations

Country	Name	City	State
Australia	Chris Obrien Lifehouse	Camperdown	New South Wales
Australia	St Vincent'S Hospital Sydney	Darlinghurst	New South Wales
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Linear Clinical Research	Nedlands	Western Australia
Australia	Peter Maccallum Cancer Centre	North Melbourne	Victoria
Belgium	Cliniques Universitaires Ucl Saint-Luc	Brussels
Canada	The Ottawa Hospital Cancer Center	Ottawa	Ontario
Canada	Princess Margaret Cancer Center	Toronto	Ontario
France	Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole	Toulouse
France	Institut Gustave Roussy	Villejuif Cedex
Italy	Irccs Istituto Clinico Humanitas	Rozzano
Spain	Hospital General Universitario Vall D Hebron	Barcelona
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Sarah Cannon Research Institue At Healthone	Denver	Colorado
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Md Anderson Cancer Center	Houston	Texas
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Weill Cornell Medicine	New York	New York
United States	Mayo Clinic Hospital	Phoenix	Arizona
United States	UCLA Healthcare Hematology-Oncology	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Dose Limiting Toxicities (DLTs)	Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.	Up to 28 days
Primary	Number of participants with Treatment-emergent Adverse Events (TEAEs)	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.	Up to 2 years and 90 days
Primary	Number of participants with TEAEs leading to dose modification or discontinuation	Number of participants with TEAEs leading to dose modification or discontinuation.	Up to 2 years and 90 days
Secondary	INCB161734 pharmacokinetic (PK) in Plasma	INCB161734 concentration in plasma.	Up to approximately 90 days
Secondary	Objective Response Rate (ORR)	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.	Up to 2 years
Secondary	Disease Control Response (DCR)	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.	Up to 2 years
Secondary	Duration of Response (DOR)	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.	Up to 2 years