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Looking for participantsPhase3

A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma

Sponsor: Incyte Corporation

NCT ID: NCT07522073

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
INCB161734 (drug), Placebo (drug), Investigator's choice of chemotherapy (drug)
How long the study runs
Study runs about 35 months (dates as stated)
About the drug or intervention
INCB161734 — drug: Oral; tablet · Placebo — drug: Oral; tablet · Investigator's choice of chemotherapy — drug: The investigator will select the chemotherapy in accordance with the protocol-defined requirements.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
588
Started
2026-04-09
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for solid tumors
  • • Phase3 - 588 participants
  • • The purpose of this study is to evaluate the efficacy and safety of standard chemotherapy with or without INCB161734 in participants with metastatic pancreatic ductal adenocarcinoma (PDAC)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with solid tumors

Where?

  • • Dundee - Investigative Site GB008
  • • Guildford - Investigative Site GB011
  • • Headington - Investigative Site GB002
  • • Leeds - Investigative Site GB001
  • • +5 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The purpose of this study is to evaluate the efficacy and safety of standard chemotherapy with or without INCB161734 in participants with metastatic pancreatic ductal adenocarcinoma (PDAC).

Solid Tumors

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders
  • How fit you need to be: ECOG 0 or better

Biomarkers mentioned

KRAS

What the study is looking for

  • ✓confirmed by testing a sample that has spread PDAC with a KRAS G12D mutation
  • ✓No prior systemic treatment in the that has spread setting
  • ✓ECOG Performance status 0-1
  • ✓healthy organ

Who cannot take part

  • ✗Prior treatment with any KRAS inhibitor
  • ✗Chronic or current active infection requiring systemic treatment within 1 week prior to the first dose of the study treatment
  • ✗Known active CNS metastases
  • ✗Other protocol-defined Inclusion/Exclusion Criteria may apply.
See the full criteria
Inclusion Criteria: * Histologically or cytologically confirmed metastatic PDAC with a KRAS G12D mutation * No prior systemic treatment in the metastatic setting * ECOG Performance status 0-1 * Adequate organ function Exclusion Criteria: * Prior treatment with any KRAS inhibitor * Chronic or current active infection requiring systemic treatment within 1 week prior to the first dose of study drug * Known active CNS metastases Other protocol-defined Inclusion/Exclusion Criteria may apply.

Where Is This Study? (9 UK sites)

Investigative Site GB008

Dundee DD1 9SY, United Kingdom

NOT_YET_RECRUITING

Investigative Site GB011

Guildford GU2 7XX, United Kingdom

NOT_YET_RECRUITING

Investigative Site GB002

Headington OX3 7LE, United Kingdom

NOT_YET_RECRUITING

Investigative Site GB001

Leeds LS9 7TF, United Kingdom

NOT_YET_RECRUITING

Investigative Site GB009

London EC1A 7BE, United Kingdom

Recruiting

Investigative Site GB004

London NW3 2QG, United Kingdom

NOT_YET_RECRUITING

Investigative Site GB003

Manchester M20 4BX, United Kingdom

NOT_YET_RECRUITING

Investigative Site GB010

Northwood HA6 2RN, United Kingdom

NOT_YET_RECRUITING

Investigative Site GB005

Norwich NR4 7UY, United Kingdom

NOT_YET_RECRUITING

How to Get in Touch

Incyte Corporation Call Center (US)

Sponsor contact

CONTACT

1.855.463.3463 medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

Sponsor contact

CONTACT

+800 00027423 eumedinfo@incyte.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10