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New treatment option for Solid Tumor
Official title NEROFE and Doxorubicin in KRAS-mutated ST2-positive Solid Tumors
ClinicalTrials.gov ID: NCT05661201
What this study is testing
What is NEROFE?
NEROFE is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn about the safety of NEROFE and doxorubicin and how well it works in patients with advanced/unresectable or metastatic solid KRAS-mutated and ST-positive solid tumors. The main question it aims to answer is to find the recommended dose and scheduled for the combination of NEROFE and doxorubicin.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Advanced/unresectable or metastatic solid tumor with a pathogenic KRAS mutation via polymerase chain reaction (PCR), next-generation sequencing...
- 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...
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- Laboratory
You likely can't join if
- 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...
- Anti-tumor therapy within 3 weeks of C1D1 (defined as, but not limited to, cytotoxic chemotherapy, immunotherapy, biological therapy, radiotherapy...
- Concurrent severe illness or uncontrolled medical condition that, in the investigator's judgement, would cause unacceptable safety risks
See the full eligibility criteria
Who can join
- 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...
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- Laboratory
- 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...
- Partial Thromboplastin Time (PTT) must be ≤ 1.5 × upper limit of normal of institution's normal range and INR (International Normalized Ratio) \< 1.5. people on anticoagulation (such as warfarin) will be permitted to...
- 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...
- 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...
- 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...
- 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)
What rules you out
- 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...
- 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...
- 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:
- Risk factors for Torsades de Pointe (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia.
- 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...
- Inability to determine the QT interval on screening (QTcF, using Fridericia's correction)
- Systolic blood pressure (SBP) \>160 mmHg or \<90 mmHg at screening
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.