NCT07522073 · Incyte Corporation
A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma
(DAWN-303)
What this study is about
The purpose of this study is to evaluate the effectiveness and safety of standard chemotherapy with or without INCB161734 in participants with metastatic pancreatic ductal adenocarcinoma (PDAC).
View original scientific description
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).
Interventions
DRUG
INCB161734
Oral; tablet
DRUG
Placebo
Oral; tablet
DRUG
Investigator's choice of chemotherapy
The investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol:
Primary outcome measures
Overall Survival (OS)
Time frame: Up to approximately 3 years
Defined as the time from the date of randomization to the date of death due to any cause.
Progression-free survival (PFS) by BICR
Time frame: Up to approximately 2 years
Defined as the time from the date of randomization to the date of the first documented progression as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause.
Objective Response by BICR
Time frame: Up to approximately 2 years
Defined as complete response (CR) or partial response (PR) as determined by BICR per RECIST v1.1.
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
- 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
- Birmingham, Alabama
- Anchorage, Alaska
- Chandler, Arizona
- Tucson, Arizona
- Duarte, California
- Fullerton, California
- La Jolla, California
- Long Beach, California
- Los Angeles, California
- Orange, California
- San Francisco, California
- Santa Monica, California
And 47 more locations — see the full list below.
Collaborators
Qiagen Manchester Ltd
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 Aug 6, 2026 · Source of record for eligibility and locations