Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF) in Combination With Fruquintinib in Refractory Metastatic Colorectal Cancer

NCT07130903 | Recruiting Phase 2 FDA Drug FDA Device

• 1 other identifier: 2025-035
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 9

Brief Summary

The goal of this clinical trial is to learn if adding amplitude-modulated radiofrequency electromagnetic fields (AM RF EMF) to Fruquintinib in metastatic colorectal cancer that has not responded to other standard treatment is:

• Effective in improving survival
• safe and tolerable

Conditions

Metastatic Colorectal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Overall survival (OS) is defined as the time duration from treatment start until death of any cause. The distribution of OS will be graphically summarized by a Kaplan-Meier (KM) curve, and median OS (mOS) and its one-sided 85% (i.e., two-sided 70%) confidence interval (CI) will be estimated using KM estimates.

  From start of treatment to 5 years after treatment discontinuation or death, whichever comes first

Secondary Outcomes (5)

• Safety and Tolerability

  From start of treatment to 28 days post device discontinuation

• Progression-free survival (PFS)

  From start of treatment to 5 years after treatment discontinuation or death, whichever comes first

• Rates of progressive disease

  From start of treatment to 5 years after treatment initiation or death, whichever comes first

• Changes in serum Carcinoembryonic Antigen (CEA)

  Through study completion, up to 1 year

• Changes in serum microRNA (miRNA)

  Through study completion, up to 1 year

Study Arms (1)

Amplitude-modulated radiofrequency electromagnetic fields device plus Fruquintinib

EXPERIMENTAL

TheraBionic P1 amplitude-modulated radiofrequency electromagnetic fields device 3 times daily (continuous) plus Fruquintinib daily (3 weeks on and 1 week off)

Drug: Fruquintinib; Device: TheraBionic P1

Interventions

Fruquintinib DRUG

Fruquintinib is a small molecule tyrosine kinase inhibitor (TKI) that targets VEGFR-1, -2, and -3, with a novel chemical structure which belongs to the quinazoline class

Also known as: Fruzaqla, HMPL-013

Amplitude-modulated radiofrequency electromagnetic fields device plus Fruquintinib

TheraBionic P1 DEVICE

TheraBionic P1 is a amplitude-modulated radiofrequency electromagnetic fields (AM RF EMF) device

Amplitude-modulated radiofrequency electromagnetic fields device plus Fruquintinib

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must have histologically or cytologically confirmed metastatic colorectal adenocarcinoma. There must be previous documentation of RAS (Rat sarcoma mutation), BRAF (B-Raf proto-oncogene, Serine/threonine kinase), MSI/MMR (microsatellite instability, mismatch repair) , and HER2 (Human epidermal growth factor receptor 2) status.
• Participant must have progressed on or been intolerant to the following previous treatments (if not contraindicated):
• Fluoropyrimidine-, oxaliplatin-, or irinotecan-based chemotherapy
• Anti-VEGF (vascular endothelial growth factor) biological therapy, such as bevacizumab, aflibercept, or ramucirumab
• If RAS is wild type, an anti-EGFR (epidermal growth factor receptor) therapy like cetuximab or panitumumab
• Participant must have evaluable disease as defined by the investigator using CT (computed tomography), MRI (magnetic resonance imaging), or PET (positron emission tomograph) scan.
• Participant must have a body weight ≥ 40 kg.
• Participant must be aged 22 years or older.
• Participant must be able to understand a written informed consent document and be willing to sign it.
• Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Participant must have adequate organ and marrow function within 14 days prior to the initiation of treatment as described below:
• Participant should have an expected lifespan of \>12 weeks as determined by the investigator.
• Fruquintinib is suspected to cause loss of human pregnancy and impaired development of the embryo or fetus. Therefore, women of child-bearing potential must agree to avoid becoming pregnant and male participants should avoid impregnating a female partner starting at initiation of treatment up until at least 14 days after the last fruquintinib dose.

You may not qualify if:

• Participants with uncontrolled hypertension per investigator discretion.
• Participants with a history or presence of gastric/duodenal ulcer or ulcerative colitis, hemorrhage of an unresected gastrointestinal tumor, perforation, fistulas, or any other condition that could, in the investigator's judgment, result in gastrointestinal hemorrhage or perforation.
• Participants with a history or presence of hemorrhage from any other site (i.e., lower GI bleed, hemoptysis or hematemesis) within two months prior to screening.
• Participants with a history of a thromboembolic event, including deep vein thrombosis (DVT), pulmonary embolism (PE), or arterial embolism within three months prior to screening unless they are on a stable dose of anticoagulant and no further evidence of active thromboses are seen on CT scan or venous Doppler imaging. Participants with saddle (massive) pulmonary embolism that require thrombectomy/thrombolysis within 12 months of screening are excluded from the trial.
• Participants with a history of stroke and/or transient ischemic attack within 12 months prior to screening.
• Participants with clinically significant cardiovascular disease, including but not limited to acute myocardial infarction or coronary artery bypass surgery within six months prior to enrollment, severe or unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, ventricular arrhythmias requiring treatment, or previous left ventricular ejection fraction (LVEF) \< 50% by echocardiogram.
• Participants with corrected QT interval using the Fridericia method (QTcF) \> 480 msec or any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in a first-degree relative.
• Participants taking concomitant medications with a known risk of causing QT prolongation and/or torsades de pointes. (Source list is continuously updated online at www.crediblemeds.org.)
• Participants taking systemic anti-neoplastic therapies four weeks prior to the first dose of study drug, including chemotherapy, biotherapy, or immunotherapy. Palliative radiation is allowed if it does not cover all evaluable disease.
• Participants taking systemic small molecule targeted therapies (e.g., tyrosine kinase inhibitors) within five half-lives or four weeks, whichever is shorter, prior to the first dose of study drug.
• Participants who have undergone major surgery within 30 days prior to the first dose of study drug or if they still have unhealed surgical incision from previous surgery.
• Participants with any unresolved toxicities from a previous antitumor treatment greater than NCI CTCAE v5.0 grade 2.
• Participants that have current drug or alcohol abuse.
• Participants with known human immunodeficiency virus (HIV) infection are not eligible if their viral load and/or CD4 (cluster of differentiation 4) count are considered poorly controlled with anti-HIV therapy.
• Participants with a known history of active viral hepatitis. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Participants that test positive for hepatitis C virus (HCV) but are currently being treated are eligible if they have an undetectable HCV viral load.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• THERABIONIC INC.: collaborator

Study Sites (9)

Karmanos Cancer Institute at McLaren Bay Region

Bay City, Michigan, 48706, United States

RECRUITING

Karmanos Cancer Institute at McLaren Clarkston

Clarkston, Michigan, 48346, United States

RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

Karmanos Cancer Institute at McLaren Flint

Flint, Michigan, 48532, United States

RECRUITING

Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, Michigan, 48910, United States

RECRUITING

Karmanos Cancer Institute at McLaren Lapeer Region

Lapeer, Michigan, 48446, United States

RECRUITING

Karmanos Cancer Institute at McLaren Macomb

Macomb, Michigan, 48043, United States

RECRUITING

Karmanos Cancer Institute at McLaren Northern Michigan, Petoskey

Petoskey, Michigan, 49770, United States

RECRUITING

Karmanos Cancer Institute at McLaren Port Huron

Port Huron, Michigan, 48060, United States

RECRUITING

MeSH Terms

Interventions

HMPL-013

Study Officials

• Mohammed Najeeb Al Hallak, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed Najeeb Al Hallak, MD

CONTACT

13135768718; alhallakm@karmanos.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 19, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): April 17, 2028
• Study Completion (Estimated): April 17, 2030
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (9)