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 Washington D.C., District of Columbia.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT07147231
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

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

First listed
Aug 29, 2025
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 (6)

FacilityCityStateZIPSite coordinators
MedStar Georgetown University HospitalWashington D.C.District of Columbia20007
Site Public Contact
202-444-2223
Benjamin A. Weinberg (PRINCIPAL_INVESTIGATOR)
Emory Saint Joseph's HospitalAtlantaGeorgia30342
Site Public Contact
404-851-7115
Olumide B. Gbolahan (PRINCIPAL_INVESTIGATOR)
Emory University Hospital MidtownAtlantaGeorgia30308
Site Public Contact
888-946-7447
Olumide B. Gbolahan (PRINCIPAL_INVESTIGATOR)
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322
Site Public Contact
404-778-1868
Olumide B. Gbolahan (PRINCIPAL_INVESTIGATOR)
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287
Site Public Contact
[email protected]
410-955-8804
Eric Christenson (PRINCIPAL_INVESTIGATOR)
University of Maryland/Greenebaum Cancer CenterBaltimoreMaryland21201
Site Public Contact
800-888-8823
Daniel Shu (PRINCIPAL_INVESTIGATOR)

Find similar trials in Washington D.C., DC

By research site
MedStar Georgetown University Hospital· Washington D.C., DCEmory Saint Joseph's Hospital· Atlanta, GAEmory University Hospital Midtown· Atlanta, GAEmory University Hospital/Winship Cancer Institute· Atlanta, GAJohns Hopkins University/Sidney Kimmel Cancer Center· Baltimore, MDUniversity of Maryland/Greenebaum Cancer Center· Baltimore, MD

Related Studies