Study on Pidnarulex and Cemiplimab for Treating Hard-to-Treat Microsatellite Stable Colorectal Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT07147231

Provider View

This clinical trial is testing a combination of two drugs, Pidnarulex and Cemiplimab, to see if they can effectively treat colorectal cancer that hasn't responded to other treatments. The study aims to find the best dose and assess the safety and effectiveness of this combination.

Patient Parameters

Program Overview

This study is exploring whether a combination of two drugs, Pidnarulex and Cemiplimab, can help treat colorectal cancer that is microsatellite stable (MSS) and has not responded to other treatments. Pidnarulex may stop cancer cells from growing by blocking certain enzymes, while Cemiplimab is an immunotherapy that helps the immune system attack cancer cells. The study will determine the best dose and evaluate the safety and effectiveness of this treatment combination.

Description

The study is divided into two phases. In Phase I, researchers will determine the best dose of Pidnarulex when used with Cemiplimab and assess the safety of this combination. In Phase II, the study will evaluate how well the treatment works in stopping cancer progression and improving survival in patients with colorectal cancer that has spread to the liver and is microsatellite stable.

Participants will receive Pidnarulex and Cemiplimab through an IV infusion on specific days of each treatment cycle, which lasts 28 days. The treatment can continue for up to 26 cycles unless the cancer progresses or side effects become unacceptable. Patients will undergo regular scans and blood tests to monitor their response to the treatment.

The study will also explore how the drugs affect cancer cells and the immune system, and whether certain genetic markers can predict a better response to the treatment. After completing the treatment, patients will have follow-up visits to monitor their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have colorectal cancer that cannot be surgically removed or has spread to other parts of the body, and standard treatments are no longer effective.
  • Have measurable cancer as defined by specific medical criteria.
  • Have a specific type of colorectal cancer that is microsatellite stable (MSS) and has proficient mismatch repair proteins (pMMR).
  • For Phase II, have at least one liver metastasis and specific genetic markers in the tumor.
  • Be 18 years or older.
  • Have a good overall health status with an ECOG performance score of 0 to 2.
  • Have adequate blood cell counts and organ function as determined by specific blood tests.
  • HIV-positive patients must have an undetectable viral load on effective therapy.
  • Patients with hepatitis B or C must have controlled or treated infections.
  • Patients with treated brain metastases are eligible if stable for at least one month.
  • Agree to use effective contraception during the study and for a specified period after treatment.
  • Be able to understand and sign an informed consent document.

Exclusion Criteria

  • Have active autoimmune diseases requiring treatment in the past two years.
  • Have had prior treatment with similar drugs or immunotherapy.
  • Have known photosensitivity disorders and do not agree to use sun protection.
  • Have not recovered from side effects of previous cancer treatments.
  • Are taking other investigational drugs or have allergies to study drugs.
  • Are taking medications that affect the metabolism of Pidnarulex.
  • Have uncontrolled medical conditions that make participation unsafe.
  • Are pregnant or breastfeeding due to potential risks to the baby.

Locations

FACILITYZIPCITYSTATE
JHU Sidney Kimmel Comprehensive Cancer Center LAO21231BaltimoreMaryland

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