OVERVIEW

Regorafenib and XmAb20717 in Treatment of High-risk Patients with Colorectal Cancer with Radiographic Occult Molecular Residual Disease After End of Established Definitive Therapy (RX-CROME)

The primary objective of this study is to assess the safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of E7386 in combination with other anticancer drug(s).

This study is being conducted at a single medical center and aims to understand the safety and effectiveness of a combined treatment called the RX regimen, which consists of two drugs called Regorafenib and XmAb20717. The study will focus on patients with metastatic colorectal cancer (mCRC) who have a specific type of DNA in their blood called circulating tumor DNA (ctDNA).

Before enrolling in the study, patients will undergo a test to check for ctDNA using a certified laboratory test. Patients who test positive for ctDNA, are without any signs of cancer on radiographic images, and have completed their main treatment (such as surgery and additional chemotherapy for stage 3 cancer) will be eligible to participate. These patients will receive the RX regimen, which involves taking regorafenib and XmAb20717.

Throughout the study, patients will undergo scans at 3 and 6 months initially, and then every 3 to 6 months for a period of 3 years. The treatment will be continued for 6 months unless the patient withdraws their consent, experiences a recurrence of the disease, or faces unacceptable side effects.

TREATMENT DETAILS

The treatment plan for this study involves two agents: Regorafenib and XmAb20717 (also known as Vudalimab).

Regorafenib will be taken orally once a day from day 1 to day 21 of a 28-day cycle, followed by a 7-day break. Patients are advised to swallow the tablets whole with water after a light meal. They will need to keep a medication diary to record each dose, which can be done electronically or in a physical diary provided by the clinic. Any unused study medication should be brought to clinic appointments for proper disposal according to institutional policies.

XmAb20717, also known as Vudalimab, will be given intravenously on day 1 and day 15 of each 28-day cycle.

Agent	Route	Day	Re-Rx
Regorafenib	Oral	D1-21	Every 28 days
XmAb20717	IV	D1 and D15	Every 28 days

Overall, this treatment plan involves taking tablets and receiving infusions to help fight cancer, and it’s important for patients to follow the instructions and keep track of their medication.

Study Schedule:

SUBJECTS ELIGIBITY

Key Eligibility Criteria

Inclusion Criteria:

For HCC (unresectable liver cancer) participants:
– Confirmed diagnosis of HCC based on histology/cytology or clinical criteria
– Excludes certain types of HCC tumors
– Includes participants with cirrhosis, chronic hepatitis B/C infection, or meeting AASLD criteria
– Must meet specific staging criteria based on Barcelona Clinic Liver Cancer (BCLC) staging system

For ST (solid tumor) participants (except HCC):
– Confirmed diagnosis of a solid tumor for which no alternative or effective therapy exists
– Life expectancy of at least 12 weeks
– Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
– Adequate organ function and blood test results
– At least one measurable lesion based on specific criteria

Specific requirements for prior treatments are mentioned for HCC, CRC (colorectal cancer), and EC (endometrial cancer) participants, please contact a study center to review criteria as they apply to you.

Exclusion Criteria:

– Various cardiac conditions
– HIV positive
– Proteinuria (excess protein in urine)
– Active infection (except for Hepatitis B/C in HCC participants)
– Meningeal carcinomatosis (cancer in the meninges)
– Central nervous system metastases (unless previously treated and stable)
– Pulmonary lymphangitic involvement causing dysfunction
– Certain bone diseases and fractures
– History of certain recent malignancies
– Discontinuation or dose reduction of lenvatinib (specific to HCC and EC participants)
– Bleeding or thrombotic disorders (specific to HCC participants)
– Gastrointestinal bleeding or active hemoptysis (coughing up blood)
– Other specific medical conditions and surgeries

The above and other standard eligibility criteria need to be reviewed by your care provider and study team to accurately determine your eligibility for trial participation.