NEROFE and Doxorubicin in KRAS-mutated ST2-positive Solid Tumors

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Georgetown University
Study ID
NCT05661201
Phase
PHASE1
Status
Recruiting
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Conditions

  • KRAS Mutation-Related Tumors
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NEROFE — DRUG
    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
  • Doxorubicin — DRUG
    weekly doses of 8 mg/m2 (fixed dose), intravenous push over 3 mins;

Study Details

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.

Key Dates

Start date
Apr 12, 2023
Status verified
Mar 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level 1: NEROFE with doxorubicin
    weekly doses of NEROFE at 96 mg/m2, intravenously over 60 minutes
  • Experimental: Dose level -1: Nerofe with doxorubicin
    weekly doses of NEROFE at 48 mg/m2, intravenously over 60 minutes
  • Experimental: Dose level 2: Nerofe with doxorubicin
    weekly doses of NEROFE at 192 mg/m2, intravenously over 60 minutes
  • Experimental: Dose Level 3: Nerofe with doxorubicin
    weekly doses of NEROFE at 288 mg/m2, intravenously over 120 minutes
  • Experimental: Dose Level 4: Nerofe with doxorubicin
    twice weekly doses of NEROFE at 288 mg/m2, intravenously over 120 minutes

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Cycle 1 Day 1 until 30 days following discontinuation of study drug, approximately 6 months. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Georgetown Lombardi Comprehensive Cancer CenterWashington D.C.District of Columbia20007
Emmy Mckissick
[email protected]
202-687-1104
Benjamin Weinberg, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Georgetown Lombardi Comprehensive Cancer Center· Washington D.C., DC

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