Recruiting NCT07522073

A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma

Phase III Interventional Solid Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: INCB161734, Placebo, Investigator's choice of chemotherapy.
Who it may be relevant to: Registry conditions: Solid Tumors. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Austria, Belgium, Canada +15
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Double-Blind, Phase 3 Study of Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma (DAWN-303)

Overview

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]
Progression-free survival (PFS) by BICR [Time frame: Up to approximately 2 years]
Objective Response by BICR [Time frame: Up to approximately 2 years]

Secondary outcome measures (11)

Duration of Response (DOR) by BICR [Time frame: Up to approximately 2 years]
Disease control by BICR [Time frame: Up to approximately 2 years]
Progression-Free Survival (PFS) by investigator assessment [Time frame: Up to approximately 2 years]
Objective response by investigator assessment [Time frame: Up to approximately 2 years]
DOR by investigator assessment [Time frame: Up to approximately 2 years]
Disease control by investigator assessment [Time frame: Up to approximately 2 years]
Treatment Emergent Adverse Events (TEAEs) [Time frame: Up to approximately 2 years and 30 days]
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment [Time frame: Up to approximately 2 years and 30 days]
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 (C30) at each postbaseline visit [Time frame: Up to approximately 2 years]
Change from baseline in EORTC QLQ-PAN26 score at each postbaseline visit [Time frame: Up to approximately 2 years]
Change from baseline in EQ-5D-5L score at each postbaseline visit [Time frame: Up to approximately 2 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Treatment