Phase I/II Randomized Study of NBTXR3 Activated by Abscopal or RadScopal Radiation in Combination With Immunotherapy (Anti-PD-1/L-1) for Patients With Advanced Solid Malignancies

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05039632
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Malignant Solid Neoplasm
  • Metastatic Malignant Neoplasm in the Liver
  • Metastatic Malignant Neoplasm in the Lung
  • Metastatic Malignant Solid Neoplasm

Eligibility Criteria

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

Interventions

  • Hafnium Oxide-containing Nanoparticles NBTXR3 — OTHER
    Given intratumorally
  • Radiation Therapy — RADIATION
    Undergo Abscopal radiation therapy
  • Radiation Therapy — RADIATION
    Undergo RadScopal radiation therapy

Study Details

This phase I/II trial studies the side effects and possible benefits of NBTXR3, radiation therapy, Anti PD-1 / PD-L1 in treating patients with solid tumor that has spread to the lung (lung metastases) and/or liver (liver metastases). NBTXR3 may help make tumor cells more sensitive to the radiation therapy. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with Anti PD-1 / PD-L1 monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving NBTXR3, radiation therapy, Anti PD-1 / PD-L1 may help to control the disease.

Key Dates

Start date
May 8, 2023
Status verified
Feb 2026
Primary completion
Feb 1, 2028
Completion
Feb 1, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort I (NBTXR3, Abscopal, Anti PD-1 / PD-L1
    COHORT I: Patients receive NBTXR3 intratumorally on day 1. Patients also receive ( anti-PD-1/L-1) intravenously (IV) on day 8. Beginning day 15, patients undergo Abscopal radiation therapy over 1-2 weeks. Cycles with ( anti-PD-1/L-1) repeat every 3-6 weeks per standard of care up to 2 years in the absence of disease progression or unacceptable toxicity.
  • Experimental: Cohort II (NBTXR3, RadScopal, Anti PD-1 / PD-L1
    COHORT II: Patients receive NBTXR3 intratumorally on day 1. Patients also receive ( anti-PD-1/L-1) IV on day 8. Beginning day 15, patients undergo RadScopal radiation therapy over 1-2 weeks. Cycles with ( anti-PD-1/L-1)repeat every 3-6 weeks per standard of care up to 2 years in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of dose limiting toxicities [ Time Frame: Up to 4 weeks post radiation therapy ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Saumil Gandhi, MD
[email protected]
713-606-2413
Saumil Gandhi, MD (PRINCIPAL_INVESTIGATOR)

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By research site
M D Anderson Cancer Center· Houston, TX

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