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RecruitingLast updated: 6 February 2024

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

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 including Cetuximab and Retifanlimab which are both monoclonal antibodies.

  • Part 2a will involve a dose escalation combination of INCB161734, cetuximab and retifanlimab.
  • Part 2b will involve a dose expansion of INCB161734 in combination with cetuximab and retifanlimab.

Conditions

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

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

More information

Trial Identifiers

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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

Eligibility

Inclusion

  • ≥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

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

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

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.

Ask your doctor if this trial could be right for you.

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