New drug combo targets tough cancers in early trial
NCT ID NCT05661201
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early-phase study tests the safety of combining an experimental drug called NEROFE with a standard chemotherapy, doxorubicin, in people with advanced solid tumors that have a KRAS mutation and express ST2. The trial aims to find the best dose and schedule for the combination. About 24 participants whose cancers have progressed after standard treatments will receive weekly infusions of both drugs.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NEROFE and doxorubicin (chemotherapy)
- What this could lead to
- If it works, this could point toward a new treatment option for people with advanced KRAS-mutated cancers that have not responded to other therapies.
- What could go wrong
- This is a very early Phase 1 trial with only 24 participants, focused on safety and dosing. It is too small to prove effectiveness, and the combination may cause significant side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2023
- Expected to finish
-
Jan 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Advanced/unresectable or metastatic solid tumor with a pathogenic KRAS mutation via polymerase chain reaction (PCR), next-generation sequencing (NGS), or other standard test (blood-based DNA testing is allowed) * Presence of tumor ST2 expression via immunochemistry assay * Progression or intolerance to all standard therapies, patient may decline standard therapies and retain eligibility (patients must not have available curative options); patients must have been exposed to 2 or fewer lines of systemic therapy for advanced disease (these patients would decline any unused standard therapies which are still available) * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 * Laboratory inclusion criteria: * Absolute neutrophil count ≥ 1500/mm3 * Hemoglobin ≥ 9.0 g/dL (transfusions are allowed to achieve this inclusion criterion) * Platelets ≥ 100 x 109/L (transfusions are NOT allowed to achieve this inclusion criterion) * Creatinine clearance ≥ 50 mL/min/1.73 m2 using the formula: creatinine clearance = \[\[140 - age(yr)\]\*weight(kg)\]/\[72\*serum Cr(mg/dL)\] (multiply by 0.85 for women). * AST and ALT ≤ 3 x the upper limit of normal of the institution's normal range and total bilirubin ≤ 1.5 x the upper limit of normal of the institution's normal range - if liver metastases are present, AST and ALT ≤ 5 x the upper limit of normal of the institution's normal range and total bilirubin ≤ 3 x the upper limit of normal of the institution's normal range unless there is persistent nausea, vomiting, right upper quadrant pain, fever, rash, or eosinophilia * Partial Thromboplastin Time (PTT) must be ≤ 1.5 × upper limit of normal of institution's normal range and INR (International Normalized Ratio) \< 1.5. Subjects on anticoagulation (such as warfarin) will be permitted to enroll as long as the INR is in the acceptable therapeutic range as determined by the investigator * Patients must have fully recovered from all effects of surgery. Patients must have had at least two weeks after minor surgery and four weeks after major surgery before starting therapy. Minor procedures requiring "twilight" sedation such as endoscopies or mediport placement may only require a 24-hour waiting period, but this must be discussed with an investigator * Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment and/or postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential * Patient is capable of understanding and complying with parameters as outlined in the protocol and able to sign and date the informed consent, approved by the Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures * Have measurable disease by RECIST v. 1.1 * Have disease amenable to serial core tumor biopsies * Suitable, stable venous access to allow for all study-related blood sampling (a central line such as a portacath (e.g. Medi-Port) or PICC is highly encouraged) Exclusion Criteria: * Age \< 18 years * Prior exposure to anthracycline chemotherapy * Receiving any active anti-cancer therapy while on study treatment * Brain metastases unless they have been previously treated with surgery and/or radiation at least 4 weeks prior to C1D1 and have a baseline MRI that shows no evidence of active/progressing intracranial disease * Anti-tumor therapy within 3 weeks of C1D1 (defined as, but not limited to, cytotoxic chemotherapy, immunotherapy, biological therapy, radiotherapy, and investigational agents), the "wash-out period" * Concurrent severe illness or uncontrolled medical condition that, in the investigator's judgement, would cause unacceptable safety risks * Women who are pregnant or breastfeeding * Concurrent use of an aromatase inhibitor * Psychiatric illness or social situation that would limit compliance with study requirements * Concurrent malignancy or malignancy within 2 years prior to starting study drug, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer, or a malignancy that the investigator deems has been definitively treated (e.g. early stage prostate cancer) * Active hepatitis B, C, or HIV (patients with hepatitis C infection are eligible if they have an undetectable viral load following definitive treatment, patients with HIV are eligible if they have an undetectable viral load and a CD4 count above 500 cells/mm3) * Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormalities, including any of the following: * History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 6 months prior to screening * History of documented congestive heart failure (New York Heart Association functional classification III-IV) * Documented cardiomyopathy * Left Ventricular Ejection Fraction (LVEF) \<50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO) at screening * Clinically significant cardiac arrhythmias (e.g. ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g. bifascicular block, Mobitz type II and third-degree AV block) * QTcF (using Fridericia's correction) of \> 480 msec * Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following: 1. Risk factors for Torsades de Pointe (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia. 2. Concomitant use of medication(s) with a known risk to prolong the QT interval and/or known to cause Torsades de Pointe that cannot be discontinued (within 5 half-lives or 7 days prior to starting study drug) or replaced by safe alternative medication 3. Inability to determine the QT interval on screening (QTcF, using Fridericia's correction) * Systolic blood pressure (SBP) \>160 mmHg or \<90 mmHg at screening
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for KRAS mutation-related tumors are added.
Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Georgetown Lombardi Comprehensive Cancer Center
RECRUITINGWashington D.C., District of Columbia, 20007, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an experimental pill boost cancer immunotherapy? early trial puts HG146 to the test
- New injectable drug tested for safety in Hard-to-Treat solid tumors
- First human test of BI 4060107 aims to find safe dose for Hard-to-Treat tumors
- Can a new drug shield kidneys from chemotherapy damage?
- Mining Responders' tumors for clues to a universal cancer therapy
- Proton boost radiotherapy aims to hit large tumors harder while sparing healthy tissue