Adenovirus (RGDCRAdCOX2F)

Conditions

• Adenocarcinoma of Pancreas

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Replicative Adenovirus Vector (RGDCRAdCOX2F) — BIOLOGICAL
  RGDCRAdcox2F (RGD) is a "local" product and is provided through this study.

Study Details

This is a single center, Phase I dose finding study of a single direct tumor injection of an RGD modified conditionally replicative adenovirus (RGDCRAdcox2F) in persons with adenocarcinoma of the pancreas. The study is designed to determine the MTD of RGDCRAdCOX2F that corresponds to the maximum desired toxicity of ≤ 20%.

Key Dates

Start date

Dec 27, 2024

Status verified

Jan 2026

Primary completion

Oct 15, 2028

Completion

Oct 15, 2029

Study Design

Enrollment

18 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Level: -1 RGDCRAdcox2F (RGD)
  Patients given 3x10\^10 vp/d of RGD. Safety arm. Enrollment begins at DL 1 in cohorts of 2 patients. A minimum of 28 days (DLT period) must separate the last patient treated in the current cohort and the 1st patient in the next cohort of 2 patients. A minimum of 21 days must separate the 1st and 2nd patient within a cohort.
• Experimental: Level: 1 RGDCRAdcox2F (RGD)
  Patients given 3x10\^11 vp/d of RGD Enrollment begins at DL 1 in cohorts of 2 patients. A minimum of 28 days (DLT period) must separate the last patient treated in the current cohort and the 1st patient in the next cohort of 2 patients. A minimum of 21 days must separate the 1st and 2nd patient within a cohort.
• Experimental: Level: 2 RGDCRAdcox2F (RGD)
  Patients given 9x10\^11 vp/d of RGD. Enrollment begins at DL 1 in cohorts of 2 patients. A minimum of 28 days (DLT period) must separate the last patient treated in the current cohort and the 1st patient in the next cohort of 2 patients. A minimum of 21 days must separate the 1st and 2nd patient within a cohort.
• Experimental: Level: 3 RGDCRAdcox2F (RGD)
  Patients given 3x10\^12 vp/d of RGD. Enrollment begins at DL 1 in cohorts of 2 patients. A minimum of 28 days (DLT period) must separate the last patient treated in the current cohort and the 1st patient in the next cohort of 2 patients. A minimum of 21 days must separate the 1st and 2nd patient within a cohort.

Primary Outcome Measure

Number of Participants Experiencing Dose Limiting Toxicity (DLT) Events [ Time Frame: 2 years ]

Central Contacts

• Edward Greeno, MD
  612-626-6418
  [email protected]

Locations (1)

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