The purpose of this study is to determine the safety, tolerability, and recommended dose of ELVN-002 in combination with trastuzumab in participants with advanced-stage HER2-positive tumors and in combination with trastuzumab, and chemotherapy in participants with advanced-stage HER2-positive colorectal cancer and breast cancer.
Parts 1 and 3 of this study are designed to evaluate preliminary safety, tolerability, and pharmacokinetics (PK) of ELVN-002 in combination with trastuzumab in participants with advanced stage HER2 positive solid tumors. In addition, Part 3 will evaluate the preliminary efficacy of ELVN-002 in combination with trastuzumab in participants with advanced-stage HER2-positive solid tumors. Part 2 of this study will evaluate the preliminary safety, tolerability, and PK of ELVN-002 in combination with trastuzumab and chemotherapy; capecitabine and oxaliplatin(CAPEOX) or 5-fluorouracil (5-FU), leucovorin (LCV) and oxaliplatin (mFOLFOX6) in participants with advanced stage HER2 positive colorectal cancer, or eribulin or capecitabine in participants with advanced-stage HER2-positive breast cancer, or paclitaxel in participants with advanced stage solid tumors. In part 4, the preliminary safety, tolerability, PK, and efficacy of ELVN-002 in combination with trastuzumab and CAPEOX or mFOLFOX6 will be evaluated in participants with HER2-positive colorectal cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
275
capsule
intravenous
intravenous
intravenous
capsule
intravenous
intravenous
intravenous
BRCR Medical Center Inc.
Plantation, Florida, United States
Washington University
St Louis, Missouri, United States
NEXT Virginia
Fairfax, Virginia, United States
Cliniques Universitaires Saint-Luc
Brussels, Belgium
CHU de Liège
Liège, Belgium
GZA Ziekenhuizen - Campus Sint-Augustinus
Incidence of dose limiting toxicities (DLTs; Phase 1a only)
DLTs will be used to support that the recommended doses for expansion are \</= maximum tolerated dose (MTD)
Time frame: 21 days
Incidence of adverse events (AEs)
AEs will be used to support that the recommended doses for expansion are likely to be tolerable
Time frame: 24 months
Incidence of laboratory abnormalities
Clinically significant laboratory abnormalities will be used to support that the recommended doses for expansion are likely to be tolerable
Time frame: 24 months
Incidence of electrocardiogram abnormalities
Clinically significant electrocardiogram abnormalities will be used to support that the recommended doses for expansion are likely to be tolerable
Time frame: 24 months
PK parameter of area under the curve of ELVN-002 (Phase 1a only)
The concentration of ELVN-002 measured in the blood over 24 hours at steady state
Time frame: 24 months
PK parameter of maximum concentration of ELVN-002 (Phase 1a only)
The maximum concentration of ELVN-002 measured in the blood at any time point at steady state
Time frame: 24 months
PK parameter of minimum concentration of ELVN-002 (Phase 1a only)
The minimum concentration of ELVN-002 measured in the blood at any time point at steady
Time frame: 24 months
PK parameter of terminal half life of ELVN-002 (Phase 1a only)
The half life of ELVN-002 calculated from the concentration of ELVN-002 measured in blood
Time frame: 24 months
Confirmed objective response rate (ORR)
For patients with measurable disease at baseline, confirmed response as assessed by investigator per RECIST v1.1
Time frame: 24 months
Duration of response (DOR; Phase 1b only)
The time from the first response to progression or death per RECIST v1.1
Time frame: 24 months
Brain metastases response (Phase 1b only)
For patients with measurable brain metastases at baseline, the percent of patients who have a confirmed response per RECIST v1.1
Time frame: 24 months
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Wilrijk, Belgium
Institut du Cancer de Montpellier - Val D'Aurelle
Montpellier, France
CHU de Poitiers
Poitiers, France
Institut de Cancérologie de l'Ouest
Saint-Herblain, France
Institut de Cancérologie Strasbourg Europe
Strasbourg, France
...and 21 more locations