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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06179160




Registration number
NCT06179160
Ethics application status
Date submitted
12/12/2023
Date registered
21/12/2023

Titles & IDs
Public title
A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
Scientific title
A Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
Secondary ID [1] 0 0
2023-507091-47-00
Secondary ID [2] 0 0
INCB161734-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - INCB161734
Treatment: Drugs - Cetuximab
Treatment: Drugs - Retifanlimab
Treatment: Drugs - GEMNabP
Treatment: Drugs - mFOLFIRINOX

Experimental: Part 1a: Dose Escalation monotherapy - INCB161734 at the protocol-defined dose strength based on cohort assignment.

Experimental: Part 1b: Dose Expansion monotherapy - INCB161734 at the protocol-defined dose strength based on cohort assignment.

Experimental: Part 1c: Pharmacodynamic cohort - INCB161734 at the protocol-defined dose strength based on cohort assignment.

Experimental: Part 2a: Dose Escalation combination - INCB161734 in combination at the protocol-defined dose strength based on cohort assignment.

Experimental: Part 2b: Dose Expansion combination - INCB161734 in combination at the protocol-defined dose strength based on cohort assignment.

Experimental: Part 1d: Food-Effect - Evaluate food effect on drug exposure as defined in the protocol.


Treatment: Drugs: INCB161734
INCB161734 will be administered at protocol defined dose.

Treatment: Drugs: Cetuximab
Cetuximab will be administered at protocol defined dose.

Treatment: Drugs: Retifanlimab
Retifanlimab will be administered at protocol defined dose.

Treatment: Drugs: GEMNabP
GEMNabP will be administered at protocol defined dose.

Treatment: Drugs: mFOLFIRINOX
mFOLFIRINOX will be administered at protocol defined dose.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with Dose Limiting Toxicities (DLTs)
Timepoint [1] 0 0
Up to 28 days
Primary outcome [2] 0 0
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Timepoint [2] 0 0
Up to 2 years and 90 days
Primary outcome [3] 0 0
Number of participants with TEAEs leading to dose modification or discontinuation
Timepoint [3] 0 0
Up to 2 years and 90 days
Secondary outcome [1] 0 0
INCB161734 pharmacokinetic (PK) in Plasma
Timepoint [1] 0 0
Up to approximately 90 days
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [3] 0 0
Disease Control Response (DCR)
Timepoint [3] 0 0
Up to 2 years
Secondary outcome [4] 0 0
Duration of Response (DOR)
Timepoint [4] 0 0
Up to 2 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2027
Actual
Sample size
Target
466
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Chris Obrien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
St Vincent'S Hospital Sydney - Darlinghurst
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
Peter Maccallum Cancer Centre - North Melbourne
Recruitment hospital [5] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
02050 - Camperdown
Recruitment postcode(s) [2] 0 0
02010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
03004 - Melbourne
Recruitment postcode(s) [4] 0 0
3051 - North Melbourne
Recruitment postcode(s) [5] 0 0
06009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Belgium
State/province [11] 0 0
Brussels
Country [12] 0 0
Belgium
State/province [12] 0 0
Edegem
Country [13] 0 0
Belgium
State/province [13] 0 0
Leuven
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
France
State/province [15] 0 0
Lyon
Country [16] 0 0
France
State/province [16] 0 0
Toulouse
Country [17] 0 0
France
State/province [17] 0 0
Villejuif Cedex
Country [18] 0 0
Italy
State/province [18] 0 0
Milan
Country [19] 0 0
Italy
State/province [19] 0 0
Rozzano
Country [20] 0 0
Italy
State/province [20] 0 0
Verona
Country [21] 0 0
Japan
State/province [21] 0 0
Chiba
Country [22] 0 0
Japan
State/province [22] 0 0
Koto-ku
Country [23] 0 0
Spain
State/province [23] 0 0
Barcelona
Country [24] 0 0
Spain
State/province [24] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Incyte Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Incyte Medical Monitor
Address 0 0
Incyte Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Incyte Corporation Call Center (US)
Address 0 0
Country 0 0
Phone 0 0
1.855.463.3463
Fax 0 0
Email 0 0
medinfo@incyte.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06179160