Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cemiplimab (REGN2810), in Treating Refractory Microsatellite Stable Colorectal Cancer

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT07147231
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Metastatic Colorectal Adenocarcinoma
  • Refractory Colorectal Adenocarcinoma
  • Stage III Colorectal Cancer AJCC v8
  • Stage IV Colorectal Cancer AJCC v8
  • Unresectable Colorectal Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo tumor biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Cemiplimab — BIOLOGICAL
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo CT or PET/CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Pidnarulex — DRUG
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT

Study Details

This phase I/II trial studies the side effects and best dose of pidnarulex when given together with cemiplimab and to see how well it works in treating patients with microsatellite stable (MSS) colorectal cancer (CRC) that does not respond to treatment (refractory). Pidnarulex may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pidnarulex with cemiplimab may be safe, tolerable and/or effective in treating patients with refractory MSS CRC.

Key Dates

Start date
Dec 21, 2026
Status verified
Apr 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
86 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I (cemiplimab, pidnarulex)
    Patients receive cemiplimab IV over 30 minutes on days 1 and 15 of each cycle and pidnarulex IV over 60 minutes on days 1 and 8 of each cycle. Cycles repeat every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection on study and CT, MRI, or PET/CT throughout the trial.
  • Active Comparator: Phase II arm I (pidnarulex)
    Patients receive pidnarulex IV over 60 minutes on days 1 and 8 of each cycle. Cycles repeat every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo tumor biopsy and CT, MRI, or PET/CT throughout the trial. Additionally, patients undergo blood sample collection on study.
  • Experimental: Phase II arm II (cemiplimab, pidnarulex)
    Patients receive cemiplimab IV over 30 minutes on days 1 and 15 of each cycle and pidnarulex IV over 60 minutes on days 1 and 8 of each cycle. Cycles repeat every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo tumor biopsy and CT, MRI, or PET/CT throughout the trial. Additionally, patients undergo blood sample collection on study.

Primary Outcome Measure

Recommended phase 2 dose (RP2D) of pidnarulex (CX-5461) with anti-programmed cell death protein 1 (anti-PD-1) (Phase 1) [ Time Frame: Up to 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
JHU Sidney Kimmel Comprehensive Cancer Center LAOBaltimoreMaryland21231
Wells A. Messersmith
[email protected]
303-724-0747
Wells A. Messersmith (PRINCIPAL_INVESTIGATOR)

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By research site
JHU Sidney Kimmel Comprehensive Cancer Center LAO· Baltimore, MD

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