588 Participants NeededMy employer runs this trial

INCB161734 + Chemotherapy for Pancreatic Cancer

(DAWN-303 Trial)

Recruiting at 245 trial locations
IC
IC
Overseen ByIncyte Corporation Call Center (ex-US)
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Incyte Corporation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well a new drug, INCB161734 (an experimental treatment), works with standard chemotherapy in treating metastatic pancreatic ductal adenocarcinoma (PDAC), a type of advanced pancreatic cancer. Researchers aim to determine if adding this drug improves the treatment's effectiveness and safety. The trial includes two groups: one receiving INCB161734 with chemotherapy and another receiving a placebo with chemotherapy. Individuals diagnosed with metastatic PDAC and a KRAS G12D mutation, who have not received prior treatment for their cancer, might be suitable candidates. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to a treatment that could soon become widely available.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that INCB161734 is generally safe. In earlier studies, patients who received this treatment alone or with other cancer therapies usually tolerated it well. These studies focus on its use for cancers with a specific mutation called KRAS G12D. The results consistently indicate that the side effects are manageable. Although any treatment can have side effects, current data suggest that INCB161734 is safe enough for further testing in more advanced trials.12345

Why do researchers think this study treatment might be promising for pancreatic cancer?

Researchers are excited about INCB161734 because it offers a new approach to treating pancreatic cancer by combining with standard chemotherapy options like mFOLFIRINOX or GemNabP. Unlike traditional treatments that primarily focus on directly attacking cancer cells, INCB161734 could potentially enhance the effectiveness of chemotherapy by targeting specific pathways in the cancer cells. This innovative mechanism may help improve patient outcomes by making the cancer cells more susceptible to the effects of chemotherapy, offering hope for better control of the disease.

What evidence suggests that INCB161734 plus chemotherapy could be an effective treatment for pancreatic cancer?

Research has shown that INCB161734 may be promising for treating pancreatic cancer. In patients with pancreatic ductal adenocarcinoma (PDAC), those taking 1,200 mg of INCB161734 daily had a 34% chance of significant tumor shrinkage. Among a group of 41 patients, 37% experienced a reduction in tumor size, and in 78% of cases, the cancer did not worsen. In this trial, one group of participants will receive INCB161734 with standard chemotherapy, while another group will receive a placebo with standard chemotherapy. These findings suggest that INCB161734, when combined with standard chemotherapy, might manage the disease better than chemotherapy alone.14567

Who Is on the Research Team?

IM

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Are You a Good Fit for This Trial?

This trial is for adults with metastatic pancreatic cancer that has a KRAS G12D mutation. Participants must not have had previous treatment for their advanced cancer, need to be in good physical condition, and have organs working well.

Inclusion Criteria

I am fully active or have only minor physical limitations.
My organs are working well enough for treatment.
I have metastatic pancreatic cancer with a KRAS G12D mutation.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard chemotherapy with or without INCB161734

Up to approximately 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 1 year

What Are the Treatments Tested in This Trial?

Interventions

  • INCB161734

Trial Overview

The study compares standard chemotherapy plus either the new drug INCB161734 or a placebo. Patients are randomly assigned to receive chemo with or without INCB161734 to see which works better and is safer.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Placebo plus chemotherapyExperimental Treatment2 Interventions
Group II: INCB161734 plus chemotherapyExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials
408
Recruited
66,800+
Steven Stein profile image

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot profile image

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Qiagen Manchester Ltd

Collaborator

Citations

Preliminary phase 1 results of INCB161734, a novel oral ...

Conclusions: INCB161734 monotherapy has a manageable safety profile, with promising early clinical efficacy and evidence of molecular response ...

Incyte Announces Phase 1 Results for its TGFβR2×PD-1 ...

PDAC patients receiving 600 mg (n=25) and 1,200 mg (n=29) INCB161734 daily demonstrated objective response rates (ORR; 20% and 34%) and high ...

ESMO 2025 - INCB161734 KRASG12D in Solid Tumors ( ...

Preliminary Phase 1 Results of INCB161734, a Novel Oral ... NSCLC, non-small cell lung cancer; OC, ovarian cancer; PDAC, pancreatic ductal adenocarcinoma.

Preliminary phase 1 results of INCB161734, a novel oral ...

Conclusions: INCB161734 monotherapy has a manageable safety profile, with promising early clinical efficacy and evidence of molecular response in pts with ...

Activity Observed with Novel KRAS Inhibitor in Pancreatic ...

Of 41 evaluable patients treated with single-agent INCB161734 at the recommended phase II dose of 1,200 mg/day, 15 (37%) achieved objective ...

INCB161734 at ASCO GI: Early Data in KRAS G12D PDAC

Conclusion. Data presented at ASCO GI 2026 indicate that INCB161734 demonstrates a manageable safety profile as monotherapy and in combination ...

Incyte Announces Phase 1 Results for its TGFβR2×PD-1 ...

In an October 19, 2025, proffered paper session, data were presented from the monotherapy arm (Part 1) of the INCB161734 Phase 1 trial in ...