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RecruitingPhase 1

A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of INCB161734 and how well people tolerate it, alone or with other cancer treatments. It is for adults with solid tumors that have grown into nearby areas or spread to other parts of the body and have a gene change called KRAS G12D.

This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • Your solid tumor has grown into nearby areas or spread to other parts of the body and has the KRAS G12D gene change.
  • For Part 1a and Part 2 Combination Groups 1, 2, and 7: Standard treatment stopped working, you could not tolerate it or were not eligible for it, you declined treatments known to help, or no standard treatment is available to improve your cancer.
  • You meet the study rules for your treatment group.
  • You are fully active or can do light work despite limits on hard physical activity (ECOG score of 0 or 1).

Who can't join

  • You have already received a drug that blocks KRAS G12D.
  • You had another known cancer that invaded nearby tissue within 1 year before your first study dose.
  • You have had an organ transplant, including a stem cell transplant from a donor.
  • You have a serious medical condition that is not under control.
  • You have or have had an abnormal ECG, a test of the heart’s electrical activity.
  • Your organs do not work well enough to meet the study rules.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * ≥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 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 sites (13)

AZ

CA

CO

FL

MA

MD

NJ

NY

PA

TN

TX