Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Date last updated
20/09/2024

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

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.


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.
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
* 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
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
322
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
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Belgium
State/province [8] 0 0
Brussels
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
France
State/province [10] 0 0
Toulouse
Country [11] 0 0
France
State/province [11] 0 0
Villejuif Cedex
Country [12] 0 0
Italy
State/province [12] 0 0
Rozzano
Country [13] 0 0
Spain
State/province [13] 0 0
Barcelona

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

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06179160
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06179160