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RecruitingLast updated: 18 May 2026

INCB: This study aims to determine how safe and tolerable a new drug is when given alone, or in combination with other anti-cancer treatments, in people with advanced or metastatic solid cancers with KRAS G12D mutationA Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

INCB

Clinical summary

Summary

This study has two parts, and each part has multiple cohorts.

In Part 1, the investigational drug being evaluated (called INCB161734) will be evaluated alone (as monotherapy).

  • Part 1a will involve a dose escalation of INCB161734 as monotherapy.
  • Part 1b will invove dose expansion of INCB161734 as monotherapy.
  • Part 1c will study INCB161734's pharmacodynamics.

In Part 2, INCB161734 will be evaluated with other anti-cancer therapies. This may include cetuximab, retifanlinab, GEMNabP, mFOLFIRINOX, FOLFOX, FOLFIRI and INCA33890.

  • Part 2a will involve a dose escalation combination of INCB161734 and other medicines.
  • Part 2b will involve a dose expansion of INCB161734 in combination with other medicines.

Conditions

This trial is treating people with advanced or metastatic solid cancers with KRAS G12D mutations

Eligibility

Inclusion

  • ≥18 years old.
  • Locally advanced or metastatic solid tumor with KRAS G12D mutation.
  • For Part 1a and Part 2 Combination Groups 1, 2, and 7: Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, declined available therapies that are known to confer clinical benefit, or no standard available treatment to improve the disease outcome.
  • Cohort specific requirements aas defined in the protocol.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion

  • 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

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

Trial sponsor

Incyte Corporation

Scientific Title

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

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