NCT06179160 · Incyte Corporation
A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
What this study is about
This study is conducted to determine the safety and how well patients handle the treatment of INCB161734 as a single agent or in combination with other anticancer therapies.
View original scientific description
This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.
Interventions
DRUG
INCB161734
INCB161734 will be administered at protocol defined dose.
DRUG
Cetuximab
Cetuximab will be administered at protocol defined dose.
DRUG
Retifanlimab
Retifanlimab will be administered at protocol defined dose.
DRUG
GEMNabP
GEMNabP will be administered at protocol defined dose.
DRUG
mFOLFIRINOX
mFOLFIRINOX will be administered at protocol defined dose.
DRUG
FOLFOX
FOLFOX will be administered at protocol defined dose.
DRUG
FOLFIRI
FOLFIRI will be administered at protocol defined dose.
DRUG
INCA33890
INCA33890 will be administered at protocol defined dose.
Primary outcome measures
Number of participants with Dose Limiting Toxicities (DLTs)
Time frame: Up to 28 days
Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 2 years and 90 days
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.
Number of participants with TEAEs leading to dose modification or discontinuation
Time frame: Up to 2 years and 90 days
Number of participants with TEAEs leading to dose modification or discontinuation.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Phoenix, Arizona
- Palo Alto, California
- Santa Monica, California
- Denver, Colorado
- Sarasota, Florida
- Baltimore, Maryland
- Boston, Massachusetts
- Hackensack, New Jersey
- New York, New York
- Philadelphia, Pennsylvania
- Nashville, Tennessee
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 22, 2026 · Source of record for eligibility and locations