31 Participants NeededMy employer runs this trial

Selumetinib + Trastuzumab Deruxtecan for Pancreatic Cancer

Recruiting at 1 trial location
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: National Cancer Institute (NCI)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of combining selumetinib and trastuzumab deruxtecan for treating advanced pancreatic cancer that cannot be surgically removed or has metastasized. Selumetinib blocks enzymes that promote cancer cell growth, while trastuzumab deruxtecan targets and delivers chemotherapy directly to specific cancer cells. Individuals diagnosed with HER2-positive pancreatic cancer, indicating the presence of a specific protein in their cancer cells, might be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this novel combination therapy.

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

Previous research has shown that the drugs selumetinib and trastuzumab deruxtecan have some safety in treating cancer. Studies found that patients taking selumetinib lived for a median of nine months. Another study showed that trastuzumab deruxtecan resulted in a median survival of 12.5 months, suggesting it might be more beneficial than other treatments.

While these studies didn't detail specific side effects, past trials revealed no major concerns, indicating these treatments are generally tolerable. However, since these are strong drugs meant to fight serious cancers, side effects are possible.

This combination therapy is relatively new, especially for pancreatic cancer, so ongoing trials aim to better understand its safety and effectiveness. Prospective participants should discuss potential risks and benefits with their healthcare provider before joining a trial.12345

Why are researchers excited about this trial's treatments?

Selumetinib and Trastuzumab Deruxtecan are unique because they target pancreatic cancer in innovative ways. Unlike traditional treatments like chemotherapy, which broadly attacks rapidly dividing cells, Selumetinib specifically inhibits the MEK pathway, a critical route for cancer cell growth. Trastuzumab Deruxtecan, on the other hand, is an antibody-drug conjugate that delivers chemotherapy directly to cancer cells expressing the HER2 protein, minimizing damage to healthy cells. Researchers are excited about these treatments because they offer a more precise attack on cancer cells, potentially leading to better outcomes with fewer side effects.

What evidence suggests that selumetinib and trastuzumab deruxtecan could be effective for pancreatic cancer?

Research has shown that trastuzumab deruxtecan (T-DXd) may help treat various cancers, including pancreatic cancer. In some studies, 37.1% of patients experienced tumor shrinkage or disappearance, known as the objective response rate (ORR). Many patients also maintained stable disease, meaning their cancer did not worsen for a period. This trial will administer a combination of selumetinib and T-DXd to participants. Selumetinib may inhibit tumor growth by blocking certain enzymes essential for cancer cell growth. This combination could benefit advanced pancreatic cancer. These findings suggest potential benefits, but further research is needed to confirm their effectiveness.678910

Who Is on the Research Team?

AK

Anup K Kasi Loknath Kumar

Principal Investigator

Yale University Cancer Center LAO

Are You a Good Fit for This Trial?

This trial is for adults (18+) with advanced pancreatic ductal adenocarcinoma that cannot be removed by surgery or has spread. Participants must have a KRAS mutation and HER2-positive tumors, measurable disease, and have tried at least one prior chemotherapy for their cancer.

Inclusion Criteria

My eligibility must be confirmed by the study's principal investigator before joining.
I have had at least one chemotherapy treatment for advanced pancreatic cancer or have chosen to skip a recommended therapy.
I have been diagnosed with pancreatic adenocarcinoma.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Patients receive selumetinib orally twice daily and DS-8201a intravenously to assess dose limiting toxicities and determine the recommended phase 2 dose

21 days per cycle
Visits every 21 days

Phase II (Expansion)

Patients continue to receive selumetinib and DS-8201a to assess objective response rate and safety

21 days per cycle, up to 1 year
Visits every 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Every 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Selumetinib
  • Trastuzumab Deruxtecan

Trial Overview

The study is testing the safety and effectiveness of combining two drugs—selumetinib and trastuzumab deruxtecan—for treating advanced pancreatic cancer. Patients will receive both drugs to see if this combination can help control the disease.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Treatment (Selumetinib and DS-8201a)Experimental Treatment6 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Citations

Testing the Combination of Anti-Cancer Drugs ...

This phase I/II trial tests the safety, side effects, best dose and how well giving selumetinib with trastuzumab deruxtecan (DS-8201a) works for ...

NCT07619521 | Testing the Combination of Anti-Cancer ...

Giving selumetinib with DS-8201a may be safe, tolerable and/or effective in treating patients with advanced, unresectable or metastatic pancreatic ductal ...

Efficacy and safety of trastuzumab deruxtecan in patients with ...

Best objective response (by INV) of stable disease was observed in 61.0% of the BTC cohort and 68.0% of the PC cohort; median overall survival was 7.0 (95% CI ...

A clinical trial is underway to evaluate the combination of ...

The study examines safety, dosing, and preliminary efficacy signals for this dual-agent strategy in an aggressive malignancy with few effective ...

Trastuzumab deruxtecan (T-DXd) in patients (pts) with ...

In DP-02, T-DXd showed tumor-agnostic potential, with an objective response rate (ORR) of 37.1% (95% CI 31.3, 43.2) and clinically meaningful survival outcomes ...

Trastuzumab Deruxtecan(T-DXd) and Afatinib Combination in ...

The median OS was 12.5 months for the T-DXd group and 8.9 months for the physician's choice group (HR = 0.60, 95% CI: 0.42, 0.86). In a ...

Phase II study of selumetinib, an orally active inhibitor of ...

Median progression-free survival (PFS) was 3.0 months (95% CI, 0.8–8.2) and median overall survival (OS) 9 months (95% CI, 2.5–20.9).

Selumetinib Completed Phase 2 Trials for Pancreatic ...

Selumetinib Completed Phase 2 Trials for Pancreatic Cancer Treatment. Trusted drug data inside clinical and healthcare software. Access detailed drug and ...

Study evaluates efficacy and safety of pancreatic cancer ...

the combination of therapies significantly improved survival even in less robust patients with metastatic pancreatic ductal adenocarcinoma ( ...

Ph2 Pan-Tumor Study of Ifnatamab Deruxtecan in Pts with ...

A Phase 1b/2 Pan-Tumor Open-Label Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid ...