Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000797572
Ethics application status
Not required
Date submitted
4/07/2024
Date registered
4/07/2024
Date last updated
4/07/2024
Date data sharing statement initially provided
4/07/2024
Type of registration
Retrospectively registered

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] 312015 0
NCT06179160
Secondary ID [2] 312016 0
2023-507091-47-00
Secondary ID [3] 312017 0
INCB161734-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumors 333624 0
Condition category
Condition code
Alternative and Complementary Medicine 330311 330311 0 0
Herbal remedies

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] 328467 0
Treatment: Drugs
Comparator / control treatment
Test by vishakha
Control group
Active

Outcomes
Primary outcome [1] 338055 0
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.
Timepoint [1] 338055 0
Up to 28 days
Primary outcome [2] 338056 0
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.
Timepoint [2] 338056 0
Up to 2 years and 90 days
Primary outcome [3] 338057 0
Number of participants with TEAEs leading to dose modification or discontinuation - Number of participants with TEAEs leading to dose modification or discontinuation.
Timepoint [3] 338057 0
Up to 2 years and 90 days
Secondary outcome [1] 434319 0
INCB161734 pharmacokinetic (PK) in Plasma - INCB161734 concentration in plasma.
Timepoint [1] 434319 0
Up to approximately 90 days
Secondary outcome [2] 434320 0
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.
Timepoint [2] 434320 0
Up to 2 years
Secondary outcome [3] 434321 0
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.
Timepoint [3] 434321 0
Up to 2 years
Secondary outcome [4] 434322 0
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.
Timepoint [4] 434322 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
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
768
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA,VIC
Recruitment outside Australia
Country [1] 26267 0
United States of America
State/province [1] 26267 0
Arizona
Country [2] 26268 0
United States of America
State/province [2] 26268 0
California
Country [3] 26269 0
United States of America
State/province [3] 26269 0
Colorado
Country [4] 26270 0
United States of America
State/province [4] 26270 0
Massachusetts
Country [5] 26271 0
United States of America
State/province [5] 26271 0
New Jersey
Country [6] 26272 0
United States of America
State/province [6] 26272 0
New York
Country [7] 26273 0
United States of America
State/province [7] 26273 0
Texas
Country [8] 26274 0
Belgium
State/province [8] 26274 0
Brussels
Country [9] 26275 0
Canada
State/province [9] 26275 0
Ontario
Country [10] 26276 0
France
State/province [10] 26276 0
Toulouse
Country [11] 26277 0
Italy
State/province [11] 26277 0
Rozzano
Country [12] 26278 0
Spain
State/province [12] 26278 0
Barcelona

Funding & Sponsors
Funding source category [1] 316366 0
Hospital
Name [1] 316366 0
mvm
Country [1] 316366 0
Aruba
Primary sponsor type
Commercial sector/Industry
Name
Incyte Corporation
Address
Country
Argentina
Secondary sponsor category [1] 318550 0
None
Name [1] 318550 0
Address [1] 318550 0
Country [1] 318550 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 315170 0
nmm
Ethics committee address [1] 315170 0
n mmn
Ethics committee country [1] 315170 0
Azerbaijan
Date submitted for ethics approval [1] 315170 0
01/07/2024
Approval date [1] 315170 0
Ethics approval number [1] 315170 0

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
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133894 0
Ms Incyte Medical Monitor
Address 133894 0
Incyte Corporation
Country 133894 0
Australia
Phone 133894 0
+61 406613421
Fax 133894 0
Email 133894 0
[email protected]
Contact person for public queries
Name 133895 0
Incyte Medical Monitor
Address 133895 0
Incyte Corporation
Country 133895 0
Australia
Phone 133895 0
+61 406613421
Fax 133895 0
Email 133895 0
[email protected]
Contact person for scientific queries
Name 133896 0
Incyte Medical Monitor
Address 133896 0
Incyte Corporation
Country 133896 0
Australia
Phone 133896 0
+61 406613421
Fax 133896 0
Email 133896 0
[email protected]

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?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23962Analytic codec1   ok1
23963Clinical study reportc2   ok2


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23962Analytic codec1   ok1
23963Clinical study reportc2   ok2

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.