NEROFE and Doxorubicin in KRAS-mutated ST2-positive Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeorgetown University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- NEROFE
- Doxorubicin
Treatment groups
24 Participants
are divided into 5 treatment groupsSponsors and collaborators
Georgetown University
Lead sponsor
Immune System Key Ltd
Collaborator
Source ClinicalTrials.gov