INCB161734 + Chemotherapy for Pancreatic Cancer
(DAWN-303 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?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive standard chemotherapy with or without INCB161734
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Placebo at the protocol-defined dose with investigator's choice of chemotherapy (mFOLFIRINOX or GemNabP) in accordance with the protocol-defined requirements.
INCB161734 at the protocol-defined dose with investigator's choice of chemotherapy (mFOLFIRINOX or GemNabP) in accordance with the protocol-defined requirements.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Incyte Corporation
Lead Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
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 ...
2.
investor.incyte.com
investor.incyte.com/news-releases/news-release-details/incyte-announces-phase-1-results-its-tgfbr2pd-1-bispecificIncyte 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 ...
3.
incytemi.com
incytemi.com/document/Poster/ESMO%202025%20-%20INCB161734%20KRASG12D%20in%20Solid%20Tumors%20%28oral%20presentation%29.pdfESMO 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 ...
5.
ascopost.com
ascopost.com/issues/march-25-2026/activity-observed-with-novel-kras-inhibitor-in-pancreatic-cancer/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 ...
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