HRX215 for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether HRX215, an experimental treatment, can help people with colorectal cancer that has spread to the liver. The researchers aim to determine if HRX215 can enhance liver regrowth and increase the likelihood of surgery after portal vein embolization (PVE), a procedure that reduces blood flow to the tumor. Participants should have colorectal cancer that has metastasized to the liver and be scheduled for PVE. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant findings.
Will I have to stop taking my current medications?
The trial requires that you stop taking any medications that inhibit CYP2D6 from the start of the trial treatment to day 28. Additionally, if you are on anticoagulation or antiplatelet therapy, you may need to interrupt these for a specified period.
Is there any evidence suggesting that HRX215 is likely to be safe for humans?
Research has shown that HRX215 is generally safe. In one study, patients who underwent liver surgery for colorectal cancer tolerated HRX215 well, with no major safety issues reported. Another study involving healthy volunteers also found HRX215 to be safe and well-tolerated.
Overall, these findings suggest that HRX215 is usually safe for people, with very few side effects reported. However, as with any treatment, there is always a chance of side effects, and ongoing studies will continue to monitor its safety.12345Why do researchers think this study treatment might be promising?
Researchers are excited about HRX215 for colorectal cancer because it offers a new approach compared to current treatments like chemotherapy and targeted therapies. Unlike standard treatments, HRX215 is administered orally, potentially increasing convenience for patients. Additionally, HRX215 is studied in combination with portal vein embolization (PVE) and hepatectomy, which may enhance surgical outcomes by optimizing liver function before surgery. This novel strategy aims to improve treatment effectiveness and patient quality of life, offering hope for better management of colorectal cancer.
What evidence suggests that HRX215 might be an effective treatment for colorectal cancer with liver metastasis?
This trial will compare HRX215 with a placebo for treating colorectal cancer that has spread to the liver. Studies have shown that HRX215 holds promise for this condition. Research indicates that HRX215 aids liver recovery by blocking a protein called MKK4, which can slow liver cell growth. This may promote liver regrowth and increase the chances of surgery for patients initially deemed ineligible. Early findings suggest that HRX215 can enhance liver regrowth, potentially leading to better surgical outcomes and a reduced risk of liver failure.25678
Who Is on the Research Team?
Scott L. Nyberg, MD, PhD
Principal Investigator
Mayo Clinic in Rochester
Are You a Good Fit for This Trial?
This trial is for adults with colorectal cancer that has spread to the liver and who have already had a portal vein embolization (PVE) procedure. Participants must be candidates for possible surgery to remove part of their liver after PVE.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive HRX215 or placebo orally twice daily from day 0 to day 27, starting 2 hours before undergoing PVE
Hepatectomy
Participants may undergo scheduled hepatectomy starting on or after day 32
Follow-up
Participants are monitored for safety and effectiveness after treatment, including post-operative morbidity and mortality
What Are the Treatments Tested in This Trial?
Interventions
- HRX215
Trial Overview
The study tests HRX215 (Darizmetinib), a new drug, versus placebo in patients after PVE. The goal is to see if HRX215 helps the liver regrow better so more patients can safely have surgery to remove tumors. Standard imaging and biopsies are also used.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Patients undergo scheduled PVE on day 0. Starting 2 hours before undergoing PVE, patients receive HRX215 PO BID (orally twice daily) on days 0-27 in the absence of disease progression or unacceptable toxicity. Starting on or after day 32, patients may undergo scheduled hepatectomy. Patients also undergo blood sample collection, CT, MRI, and CT-PET throughout the study. Additionally, patients may undergo tissue biopsy during scheduled hepatectomy on study.
Patients undergo scheduled PVE on day 0. Starting 2 hours before undergoing PVE, patients receive placebo PO BID (orally twice daily) on days 0-27 in the absence of disease progression or unacceptable toxicity. Starting on or after day 32, patients may undergo scheduled hepatectomy. Patients also undergo blood sample collection, CT, MRI, and CT-PET throughout the study. Additionally, patients may undergo tissue biopsy during scheduled hepatectomy on study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Citations
HRX215, A First Generation MKK4 Inhibitor Drug, for the ...
Giving HRX215 after a PVE may help improve the rate of liver regrowth and increase the likelihood of hepatectomy in patients with colorectal ...
2.
biopharmaboardroom.com
biopharmaboardroom.com/news/13/3427/heparegenix-doses-first-patient-in-phase-ib-trial-of-hrx-215-for-liver-regeneration-after-colorectal-cancer-surgery.htmlHepaRegeniX Doses First Patient in Phase Ib Trial of HRX ...
HRX-215 enters clinical evaluation to enhance hepatocyte regeneration and improve surgical outcomes in advanced-stage liver disease, with initial data readout ...
3.
ddw-online.com
ddw-online.com/heparegenix-completes-phase-ib-trial-for-liver-regeneration-drug-40452-202602/HepaRegeniX completes Phase Ib trial for liver ...
“By accelerating and enhancing liver regeneration, HRX-215 has the potential to improve post-operative outcomes and enable more patients to ...
4.
cancernetwork.com
cancernetwork.com/view/effectiveness-toxicity-and-survival-predictors-of-regorafenib-in-metastatic-colorectal-cancer-a-multicenter-study-of-routinely-collected-dataA Multicenter Study of Routinely Collected Data
Median OS was 8.03 months (95% CI, 5.90-10.17), and median PFS was 2.90 months (95% CI, 2.59-3.21). Eighty-eight patients (97.8%) experienced ...
5.
vesaliusbiocapital-4.com
vesaliusbiocapital-4.com/heparegenix-doses-first-patient-in-phase-ib-trial-with-small-molecule-inhibitor-hrx-215-to-promote-liver-regeneration/HepaRegeniX Doses First Patient in Phase Ib Trial with ...
The trial is evaluating the safety and efficacy of HRX-215 ... HRX-215 in 85 patients with liver metastases originating from colorectal cancer.
Safety of HRX215 in Patients After Minor and Major Liver ...
The goal of this clinical trial is to learn if HRX215 is safe, tolerable and active in adults who have undergone liver resection due to colorectal carcinoma ...
Safety Of HRX215 In Patients After Minor And Major Liver ...
The goal of this clinical trial is to learn if HRX215 is safe, tolerable and active in adults who have undergone liver resection due to colorectal carcinoma ...
Safety of HRX215 in Patients After Minor and Major Liver ...
The goal of this clinical trial is to learn if HRX215 is safe, tolerable and active in adults who have undergone liver resection due to colorectal carcinoma ...
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