Testing the Combination of Anti-Cancer Drugs, Selumetinib and DS-8201a, for Advanced Pancreatic Ductal Adenocarcinoma

Sponsor
National Cancer Institute (NCI)
Study ID
NCT07619521
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Pancreatic Ductal Adenocarcinoma
  • Metastatic Pancreatic Ductal Adenocarcinoma
  • Stage III Pancreatic Cancer AJCC v8
  • Stage IV Pancreatic Cancer AJCC v8
  • Unresectable Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Diagnostic Imaging Testing — PROCEDURE
    Undergo diagnostic imaging
  • Echocardiography Test — PROCEDURE
    Undergo echocardiography
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA scan
  • Selumetinib — DRUG
    Given PO
  • Trastuzumab Deruxtecan — BIOLOGICAL
    Given IV

Study Details

This phase I/II trial tests the safety, side effects, best dose and how well giving selumetinib with DS-8201a works for the treatment of pancreatic ductal adenocarcinoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic). Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. DS-8201a is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers deruxtecan to kill them. Giving selumetinib with DS-8201a may be safe, tolerable and/or effective in treating patients with advanced, unresectable or metastatic pancreatic ductal adenocarcinoma.

Key Dates

Start date
Sep 8, 2026
Status verified
Jun 2026
Primary completion
Oct 30, 2026
Completion
Oct 30, 2026

Study Design

Enrollment
31 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (Selumetinib and DS-8201a)
    Patients receive selumetinib PO BID on days 1-21 of each cycle and DS-8201a IV, over 30-90 minutes, on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography or MUGA scan, diagnostic imaging and blood sample collection throughout the study.

Primary Outcome Measure

Occurrence of dose limiting toxicities (DLTs) (dose escalation phase) [ Time Frame: From baseline up to day 21 ]

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