Solid TumorPhase 1NCT05661201
NEROFE and Doxorubicin in KRAS-mutated ST2-positive Solid Tumors
A Phase 1 study testing NEROFE and Doxorubicin in people with Solid Tumor and KRAS Mutation-Related Tumors, run by Georgetown University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, KRAS Mutation-Related Tumors
- What is being tested?
- NEROFE and Doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2023to Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 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
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- 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)
Who cannot join
- 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
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- 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:
- 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 by safe alternative medication
- Inability to determine the QT interval on screening (QTcF, using Fridericia's correction)
- Systolic blood pressure (SBP) >160 mmHg or <90 mmHg at screening
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007
Emmy Mckissick, 202-687-1104, mm5350@georgetown.edu
Benjamin Weinberg, MD
About this study
Official title: Phase I Study of NEROFE and Doxorubicin in KRAS-mutated ST2-positive Solid Tumors
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. Participants will receive weekly doses of NEROFE and doxorubicin.
- Conditions
- Solid Tumor, KRAS Mutation-Related Tumors
- Being tested
- NEROFE, Doxorubicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEROFEDrug
weekly doses of NEROFE (48-288 mg/m2) (dose level 1: 96 mg/m2, dose level -1: 48 mg/m2, dose level 2: 192 mg/m2, dose level 3: 288 mg/m2), intravenously over 60 minutes
DoxorubicinDrug
Also called adriamycin
weekly doses of 8 mg/m2 (fixed dose), intravenous push over 3 mins;
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1: NEROFE with doxorubicin | Experimental | weekly doses of NEROFE at 96 mg/m2, intravenously over 60 minutes Receives: Drug: NEROFE; Drug: Doxorubicin |
| Dose level -1: Nerofe with doxorubicin | Experimental | weekly doses of NEROFE at 48 mg/m2, intravenously over 60 minutes Receives: Drug: NEROFE; Drug: Doxorubicin |
| Dose level 2: Nerofe with doxorubicin | Experimental | weekly doses of NEROFE at 192 mg/m2, intravenously over 60 minutes Receives: Drug: NEROFE; Drug: Doxorubicin |
| Dose Level 3: Nerofe with doxorubicin | Experimental | weekly doses of NEROFE at 288 mg/m2, intravenously over 120 minutes Receives: Drug: NEROFE; Drug: Doxorubicin |
| Dose Level 4: Nerofe with doxorubicin | Experimental | twice weekly doses of NEROFE at 288 mg/m2, intravenously over 120 minutes Receives: Drug: NEROFE; Drug: Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Safety and tolerability of NEROFE and doxorubicin in patients with advanced KRAS-mutated and ST2-positive solid tumors
Measured: Cycle 1 Day 1 until 30 days following discontinuation of study drug, approximately 6 months.
Incidence of Serious Adverse events
Safety and tolerability of NEROFE and doxorubicin in patients with advanced KRAS-mutated and ST2-positive solid tumors
Measured: From time of Consent until 30 days following discontinuation of study drug, approximately 6 months.
Incidence of Adverse events meeting protocol defined dose limiting toxicities
Safety and tolerability of NEROFE and doxorubicin in patients with advanced KRAS-mutated and ST2-positive solid tumors
Measured: Cyce 1 Day 1 through 28 days
Secondary outcomes (10)
Pharmacokinetic (PK): AUC (area under the curve) 0-24 hours
Pharmacokinetics of NEROFE and doxorubicin in patients with advanced KRAS-mutated and ST2-positive solid tumors; AUC 0-24 hours calculated using the trapezoidal rule [(Concentration at 0 hour + concentration at 24 hours) x 24]/2
Measured: 24 hours, on Cycle 1 Day 1 and Cycle 2 Day 1 (each cycle is 28 days)
Pharmacokinetic: Cmax
Pharmacokinetics of NEROFE and doxorubicin in patients with advanced KRAS-mutated and ST2-positive solid tumors; maximum 24 hour concentration
Measured: 24 hours, on Cycle 1 Day 1 and Cycle 2 Day 1 (each cycle is 28 days)
Pharmacokinetic: Cmin
Pharmacokinetics of NEROFE and doxorubicin in patients with advanced KRAS-mutated and ST2-positive solid tumors; minimum 24 hours concentration
Measured: 24 hours, on Cycle 1 Day 1 and Cycle 2 Day 1 (each cycle is 28 days)
Pharmacokinetic: Tmax
Pharmacokinetics of NEROFE and doxorubicin in patients with advanced KRAS-mutated and ST2-positive solid tumors; hour at which Cmax occurs
Measured: 24 hours, on Cycle 1 Day 1 and Cycle 2 Day 1 (each cycle is 28 days)
Pharmacokinetic: t1/2
Pharmacokinetics of NEROFE and doxorubicin in patients with advanced KRAS-mutated and ST2-positive solid tumors; the time at which the concentration is at half its initial value
Measured: 24 hours, on Cycle 1 Day 1 and Cycle 2 Day 1 (each cycle is 28 days)
Pharmacodynamics: Change in ST2 expression
Pharmacodynamics of NEROFE and doxorubicin in patients with advanced KRAS--mutated and ST2-positive solid tumors; Change in ST2 expression by IHC will be quantified by percentage of positively stained cells in pre- vs. on-treatment tumor biopsies
Measured: pretreatment to Cycle 2 Day 15 (each cycle is 28 days)
Pharmacodynamics: Change in KRAS mRNA
Pharmacodynamics of NEROFE and doxorubicin in patients with advanced KRAS-mutated and ST2-positive solid tumors; Change in KRAS mRNA will be quantified by qPCR in blood and tissue (pre- vs. on-treatment blood samples and tumor biopsies).
Measured: pretreatment to Cycle 2 Day 15 (each cycle is 28 days)
Progression free survival (PFS)
time from the date of the initial treatment to the date of first documented disease progression or death due to any cause, whichever occurs first.
Measured: 6 months
Overall Survival (OS)
Overall Survival (OS): defined as the date of the initial treatment to the date of the participant's death.
Measured: 2 years 6 months
Overall Response Rate (ORR)
The proportion of participants who achieve a PR or better according to the RECIST version 1.1 criteria.
Measured: every 8 weeks until progression, approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start12 Apr 2023
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Immune System Key Ltd
- Responsible party
- Sponsor
- Investigators
- Benjamin Weinberg, MD, Study chair, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661201
- Sponsor's protocol ID
- STUDY00005711
- Status last verified
- Mar 2026
- First submitted
- 28 Nov 2022
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of NEROFE and Doxorubicin in KRAS-mutated ST2-positive Solid Tumors
- ClinicalTrials.gov ID
- NCT05661201
- Acronym / sponsor ID
- STUDY00005711
- Conditions
- Solid Tumor, KRAS Mutation-Related Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Immune System Key Ltd
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Participants will receive weekly doses of NEROFE and doxorubicin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1: NEROFE with doxorubicin | Experimental | Drug: NEROFE, Drug: Doxorubicinweekly doses of NEROFE at 96 mg/m2, intravenously over 60 minutes |
| Dose level -1: Nerofe with doxorubicin | Experimental | Drug: NEROFE, Drug: Doxorubicinweekly doses of NEROFE at 48 mg/m2, intravenously over 60 minutes |
| Dose level 2: Nerofe with doxorubicin | Experimental | Drug: NEROFE, Drug: Doxorubicinweekly doses of NEROFE at 192 mg/m2, intravenously over 60 minutes |
| Dose Level 3: Nerofe with doxorubicin | Experimental | Drug: NEROFE, Drug: Doxorubicinweekly doses of NEROFE at 288 mg/m2, intravenously over 120 minutes |
| Dose Level 4: Nerofe with doxorubicin | Experimental | Drug: NEROFE, Drug: Doxorubicintwice weekly doses of NEROFE at 288 mg/m2, intravenously over 120 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
Key exclusion criteria (23 listed)
- 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"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEROFEweekly doses of NEROFE (48-288 mg/m2) (dose level 1: 96 mg/m2, dose level -1: 48 mg/m2, dose level 2: 192 mg/m2, dose level 3: 288 mg/m2), intravenously over 60 minutes | Drug | Dose Level 1: NEROFE with doxorubicin, Dose Level 3: Nerofe with doxorubicin, Dose Level 4: Nerofe with doxorubicin, Dose level -1: Nerofe with doxorubicin, Dose level 2: Nerofe with doxorubicin |
| DoxorubicinAlso: adriamycinweekly doses of 8 mg/m2 (fixed dose), intravenous push over 3 mins; | Drug | Dose Level 1: NEROFE with doxorubicin, Dose Level 3: Nerofe with doxorubicin, Dose Level 4: Nerofe with doxorubicin, Dose level -1: Nerofe with doxorubicin, Dose level 2: Nerofe with doxorubicin |
Primary outcome
Incidence of adverse events
Time frame: Cycle 1 Day 1 until 30 days following discontinuation of study drug, approximately 6 months.
Safety and tolerability of NEROFE and doxorubicin in patients with advanced KRAS-mutated and ST2-positive solid tumors
Incidence of Serious Adverse events
Time frame: From time of Consent until 30 days following discontinuation of study drug, approximately 6 months.
Safety and tolerability of NEROFE and doxorubicin in patients with advanced KRAS-mutated and ST2-positive solid tumors
Incidence of Adverse events meeting protocol defined dose limiting toxicities
Time frame: Cyce 1 Day 1 through 28 days
Safety and tolerability of NEROFE and doxorubicin in patients with advanced KRAS-mutated and ST2-positive solid tumors
10 secondary outcomes
Pharmacokinetic (PK): AUC (area under the curve) 0-24 hours
Time frame: 24 hours, on Cycle 1 Day 1 and Cycle 2 Day 1 (each cycle is 28 days)
Pharmacokinetic: Cmax
Time frame: 24 hours, on Cycle 1 Day 1 and Cycle 2 Day 1 (each cycle is 28 days)
Pharmacokinetic: Cmin
Time frame: 24 hours, on Cycle 1 Day 1 and Cycle 2 Day 1 (each cycle is 28 days)
Pharmacokinetic: Tmax
Time frame: 24 hours, on Cycle 1 Day 1 and Cycle 2 Day 1 (each cycle is 28 days)
Pharmacokinetic: t1/2
Time frame: 24 hours, on Cycle 1 Day 1 and Cycle 2 Day 1 (each cycle is 28 days)
Pharmacodynamics: Change in ST2 expression
Time frame: pretreatment to Cycle 2 Day 15 (each cycle is 28 days)
Pharmacodynamics: Change in KRAS mRNA
Time frame: pretreatment to Cycle 2 Day 15 (each cycle is 28 days)
Progression free survival (PFS)
Time frame: 6 months
Overall Survival (OS)
Time frame: 2 years 6 months
Overall Response Rate (ORR)
Time frame: every 8 weeks until progression, approximately 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin Weinberg, MD study chair
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NEROFE and Doxorubicin in people with Solid Tumor and KRAS Mutation-Related Tumors, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emmy Mckissick ((202) 687-1104, mm5350@georgetown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Cycle 1 Day 1 until 30 days following discontinuation of study drug, approximately 6 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.