REC-1245 for Cancer

(No information Trial)

Recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Recursion Pharmaceuticals Inc.

Disqualifiers: GI malabsorption, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: up to 24 months

85 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a multi-center, open-label study to investigate the safety, tolerability, PK, PD, and preliminary activity of REC-1245 administered orally on a once daily (QD) schedule in participants with unresectable, locally advanced, or metastatic solid tumors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What safety data exists for REC-1245 in humans?

The safety profile of regorafenib, a similar molecular target anticancer drug, shows that it can cause serious adverse events like hand-foot skin reaction, high blood pressure, fatigue, diarrhea, and liver issues. These side effects often occur early in treatment but can be managed with dose adjustments and close monitoring. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for individuals with cancers that can't be removed by surgery, are locally advanced, or have spread to other parts of the body. It's open to those with primary cancer, oral and head & neck cancers, or lymphoma.

Inclusion Criteria

My cancer is advanced and cannot be removed by surgery.

I am fully active and can carry on all my pre-disease activities without restriction.

My cancer can be measured by scans according to specific criteria.

Exclusion Criteria

I have been treated with an RBM39 degrader before.

I have serious stomach or nutrient absorption problems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive REC-1245 orally on a once daily schedule for up to 2 years

up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• REC-1245

Trial Overview The study is testing REC-1245, a new medication given orally once daily. The goal is to assess its safety and how well it works in treating various advanced cancers.

Participant Groups

Group I: Phase 1b Dose #2 Experimental Treatment 1 Intervention

Dose #2 TBD

Group II: Phase 1b Dose #1 Experimental Treatment 1 Intervention

Dose Confirmation

Group III: Phase 1a Experimental Treatment 1 Intervention

Dose Escalation

REC-1245 is already approved in United States, European Union for the following indications:

Approved in United States as REC-1245 for:

• None approved; currently in Phase 1/2 clinical trial for biomarker-enriched solid tumors and lymphoma

Approved in European Union as REC-1245 for:

• None approved; currently in Phase 1/2 clinical trial for biomarker-enriched solid tumors and lymphoma

Who Is Running the Clinical Trial?

Recursion Pharmaceuticals Inc.

Lead Sponsor

Trials

6

Recruited

450+

Findings from Research

Regorafenib (REG) was associated with a high incidence of renal adverse drug reactions (ADRs), accounting for 93.1% of 379 reports, with significant safety signals for conditions like chromaturia, hydronephrosis, and acute kidney injury.

Encorafenib (ENC) also showed potential renal toxicity, particularly with acute kidney injury and dysuria, indicating that both drugs may pose risks to kidney health in patients with metastatic colorectal cancer (mCRC) that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renal Disorders with Oral Tyrosine Kinase Inhibitors in Metastatic Colorectal Cancer: An Analysis from the FDA Adverse Event Reporting System Database. Russo, G., Barbieri, MA., Sorbara, EE., et al.[2023]

The PRO-CTCAE tool allows breast cancer patients to report their own symptoms during chemotherapy, providing real-time feedback to clinicians, which could improve patient care.

This national study aims to assess the impact of electronic PRO-CTCAE reporting on critical treatment outcomes such as dose reduction, hospitalization, and febrile neutropenia, marking a significant step in understanding patient-reported outcomes in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Routine surveillance for symptomatic toxicities with real-time clinician reporting in Danish breast cancer patients-Organization and design of the first national, cluster randomized trial using the Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE). Pappot, H., Baeksted, C., Knoop, A., et al.[2019]

Regorafenib is the first approved tyrosine kinase inhibitor for metastatic colorectal cancer, showing significant improvements in progression-free and overall survival in patients who had previously undergone multiple lines of chemotherapy and targeted therapies, based on results from two phase III trials.

While regorafenib has a safety profile similar to other tyrosine kinase inhibitors, it is associated with specific adverse events like hand-foot skin reaction and hypertension, which can be managed effectively through patient education and timely dose adjustments, allowing patients to continue benefiting from the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient outcomes with regorafenib for metastatic colorectal cancer - patient selection, dosing, patient education, prophylaxis, and management of adverse events. Hofheinz, RD., Arnold, D., Kubicka, S., et al.[2015]

In a study involving 299 patients with refractory metastatic colorectal cancer, different dosing schedules of regorafenib were evaluated for safety, showing that 60% of patients in the standard dose group experienced severe treatment-related adverse events, compared to 55% and 54% in the lower dose and intermittent dosing groups, respectively.

The alternative dosing schedules were found to be feasible and safe, with the intermittent dosing showing a potential numerical improvement in managing severe adverse events, particularly during the initial treatment cycles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised phase 2 study comparing different dose approaches of induction treatment of regorafenib in previously treated metastatic colorectal cancer patients (REARRANGE trial). Argilés, G., Mulet, N., Valladares-Ayerbes, M., et al.[2023]

A meta-analysis of 53 Phase II/III/IV trials involving nearly 20,000 patients revealed that molecular target anticancer drugs significantly increase the risk of serious adverse events (SAEs) by 57% and fatal adverse events (FAEs) by 51% compared to placebo.

The overall incidence rates for SAEs and FAEs were found to be 26.9% and 2.3%, respectively, highlighting the need for careful monitoring and preventive measures for patients receiving these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of serious adverse event and fatal adverse event with molecular target anticancer drugs in cancer patients: A meta-analysis. Wang, Z., Yang, X., Wang, J., et al.[2020]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Renal Disorders with Oral Tyrosine Kinase Inhibitors in Metastatic Colorectal Cancer: An Analysis from the FDA Adverse Event Reporting System Database. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Routine surveillance for symptomatic toxicities with real-time clinician reporting in Danish breast cancer patients-Organization and design of the first national, cluster randomized trial using the Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE). [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Improving patient outcomes with regorafenib for metastatic colorectal cancer - patient selection, dosing, patient education, prophylaxis, and management of adverse events. [2015]

4. England pubmed.ncbi.nlm.nih.gov

A randomised phase 2 study comparing different dose approaches of induction treatment of regorafenib in previously treated metastatic colorectal cancer patients (REARRANGE trial). [2023]

5. India pubmed.ncbi.nlm.nih.gov

Risk of serious adverse event and fatal adverse event with molecular target anticancer drugs in cancer patients: A meta-analysis. [2020]