Actively Recruiting
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
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
86
Participants Needed
1
Research Sites
40 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have pathologically confirmed colorectal adenocarcinoma that is unresectable and/or metastatic and for which standard curative or palliative measures do not exist or are no longer effective
- Patients must have measurable disease as defined by RECIST version 1.1
- Patients must have pathologically confirmed proficient mismatch repair proteins (pMMR) and/or non-microsatellite-high status
- Phase 2 patients must have at least one liver metastasis at study entry
- Phase 2 patients must have tumor molecular testing showing MYC amplification or deleterious FBXW7 mutation
- Phase 2 patients must have at least one tumor lesion suitable for biopsy
- Patients must complete a 28-day washout period for EGFR inhibitors
- Patients must have progressed on or be intolerant to fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab, and EGFR inhibitors
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Absolute neutrophil count 1,500/mcL or higher
- Platelet count 100,000/mcL or higher
- Hemoglobin 9 g/dL or higher
- Total bilirubin 1.5 times upper limit of normal or lower (up to 3 mg/dl allowed for Gilbert disease)
- AST/ALT up to 3 times institutional upper limit of normal (5 times if liver involvement)
- Glomerular filtration rate 50 mL/min/1.73 m² or higher
- HIV-infected patients on effective therapy with undetectable viral load within 6 months are eligible
- Patients with chronic hepatitis B must have undetectable viral load on therapy
- Patients with hepatitis C must be treated and cured or have undetectable viral load if on treatment
- Patients with treated brain metastases stable for at least 1 month
- Patients with prior or concurrent malignancy not interfering with safety or efficacy
- Patients with cardiac function classified as New York Heart Association class II or better
- Women and men must agree to use effective contraception during and after the study
- Ability to understand and sign informed consent
You will not qualify if you...
- Patients with active autoimmune diseases requiring systemic treatment in past 2 years
- Patients previously treated with RNA polymerase inhibitors, G quadruplex stabilizers, or immunotherapy including PD-1 or PD-L1 inhibitors
- Patients with known photosensitivity disorders who do not agree to use sun protection
- Patients with history of cicatricial conjunctivitis or active ocular surface disease
- Patients who have not recovered from prior anti-cancer therapy adverse events above grade 1 except alopecia
- Patients currently receiving other investigational agents
- Patients with allergic reactions to compounds similar to pidnarulex or cemiplimab
- Patients using strong CYP3A4 inhibitors or inducers
- Patients taking corticosteroids above 10 mg prednisone daily or other immunosuppressive agents
- Patients with uncontrolled illness or conditions making participation unsafe
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
JHU Sidney Kimmel Comprehensive Cancer Center LAO
Baltimore, Maryland, United States, 21231
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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