iExosomes in Treating Participants With Metastatic Pancreas Cancer With KrasG12D Mutation

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03608631
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Mesenchymal Stromal Cells-derived Exosomes with KRAS G12D siRNA — DRUG
    Given IV

Study Details

This phase I trial studies the best dose and side effects of mesenchymal stromal cells-derived exosomes with KrasG12D siRNA (iExosomes) in treating participants with pancreatic cancer with KrasG12D mutation that has spread to other places in the body. iExosomes may work better at treating pancreatic cancer.

Key Dates

Start date
Jan 27, 2021
Status verified
May 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

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

Arms

  • Experimental: Treatment (iExosomes)
    Participants receive mesenchymal stromal cells-derived exosomes with KrasG12D siRNA IV over 15-20 minutes on days 1, 4, and 10. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Participants who respond may continue 3 additional courses.

Primary Outcome Measure

Maximum Tolerated Dose Determined by Dose Limiting Toxicity [ Time Frame: First 4 weeks of treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Brandon Smaglo, MD
[email protected]
713-792-2828
Brandon Smaglo (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
M D Anderson Cancer Center· Houston, TX

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