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ELVN-002 with trastuzumab with or without chemotherapy in HER2-positive solid tumors
NL-OMON58752Phase 2
Key facts
- Status
- Completed
- Start
- Oct 2024
- Countries
- 1
- Sponsor
- Enliven Therapeutics
- Modality
- Small Molecules
- Drugs
- elvn-002
- Conditions
- Nonhematologic neoplasmscolorectal cancer (CRC)breast cancer
01
Overview
Phase 2, open-label trial of elvn-002 in Nonhematologic neoplasms, colorectal cancer (CRC) and breast cancer (6 arms), sponsored by Enliven Therapeutics. Started Oct 2024; status: completed.
02
Design
6 arms- Study design
- Non-randomizedOpen-label
ELVN-002 + trastuzumab
Combination arm for advanced HER2-positive solid tumors.
ELVN-002 + trastuzumab + CAPEOX
Combination arm for HER2-positive colorectal cancer using capecitabine and oxaliplatin.
ELVN-002 + trastuzumab + mFOLFOX6
Combination arm for HER2-positive colorectal cancer using fluorouracil, leucovorin, and oxaliplatin.
ELVN-002 + trastuzumab + eribulin
Combination arm for HER2-positive breast cancer.
ELVN-002 + trastuzumab + capecitabine
Combination arm for HER2-positive breast cancer.
ELVN-002 + trastuzumab + paclitaxel
Combination arm for HER2-positive solid tumors or breast cancer depending on cohort.
03
Who it enrols
Adults with pathologically confirmed locally advanced, relapsed/refractory, or unresectable metastatic HER2-positive solid tumors, including colorectal and breast cancer, were eligible if they had ECOG 0-1, adequate cardiac function, and protocol-specified prior treatment. Patients with uncontrolled CNS disease, significant cardiac disease, active infection, active hepatitis B or C, unresolved toxicities, major recent surgery, or contraindications to study drugs were excluded.
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