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ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer
The goal of this clinical trial is to test ELVN-002 in people with cancers that have an abnormal HER2 gene. The main question the trial aims to answer is if ELVN-002 is safe and tolerable at different doses. A second main question is to evaluate the concentration of ELVN-002 in the blood at different doses and to see how this correlates with safety and see how the concentration of drug changes over time.
The third main question is to see if ELVN-002 works to shrink cancers that have HER2 genetic abnormalities, particularly non-small cell lung cancer.
Study details:
There are 4 parts to the trial. Part 1 is a dose escalation with ELVN-002 monotherapy for people with advanced stage solid tumors that have a HER2 mutation, amplification or high HER2 over-expression. Part 2 is an ELVN-002 monotherapy dose exploration where additional people may be enrolled at dose levels that have cleared the dose escalation in Part 1 to further evaluate the safety, tolerability, pharmacokinetics and clinical activity.
Part 3 is a dose expansion of ELVN-002 monotherapy which will enroll up to 40 patients people with advanced stage HER2 mutant non-small cell lung cancer. Patients in Part 3 will be randomized 1:1 to receive one of two dose levels. Part 4 is a combination dose escalation where, based on the results of Part 1 and 2, a combination of ELVN-002 and either fam-trastuzumab deruxtecan-nxki (in HER2 mutant non-small cell lung cancer) or trastuzumab emtansine (in HER2 positive breast cancer) will be evaluated for safety and tolerability.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-03-20
Primary completion: 2026-07-01
Study completion finish: 2026-07-01
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT05650879
Intervention or treatment
DRUG: ELVN-002
DRUG: Fam-Trastuzumab Deruxtecan-Nxki
DRUG: Trastuzumab emtansine
Conditions
- • HER2 Mutant Non-small Cell Lung Cancer
- • HER2-positive Metastatic Breast Cancer
- • HER2 Gene Mutation
- • HER2 Amplification
Find a site
Closest Location:
Linear Clinical Research Limited
Research sites nearby
Select from list below to view details:
Linear Clinical Research Limited
Nedlands, Western Australia, Australia
Macquarie University Hospital
Westmead, New South Wales, Australia
Blacktown Hospital
Darlinghurst, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Phase 1a Monotherapy Dose Escalation
| DRUG: ELVN-002
|
EXPERIMENTAL: Phase 1a Monotherapy Dose Exploration
| DRUG: ELVN-002
|
EXPERIMENTAL: Phase 1b Monotherapy Dose Expansion
| DRUG: ELVN-002
|
EXPERIMENTAL: Phase 1a Combination Dose Escalation with T-DXd
| DRUG: ELVN-002
|
EXPERIMENTAL: Phase 1a Combination Dose Escalation with T-DM1
| DRUG: ELVN-002
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Incidence of dose limiting toxicities in Phase 1a monotherapy | Not Specified | 21 days |
Incidence of adverse events in Phase 1a monotherapy | Not Specified | 24 months |
incidence of laboratory abnormalities in Phase 1a monotherapy | Not Specified | 24 months |
incidence of ECG abnormalities in Phase 1a monotherapy | Not Specified | 24 months |
incidence of dose limiting toxicities in Phase 1a combination with fam-trastuzumab deruxtecan (T-DXd) | Not Specified | 42 days |
Incidence of adverse events in Phase 1a combination with T-DXd | Not Specified | 24 months |
incidence of laboratory abnormalities in Phase 1a combination with T-DXd | Not Specified | 24 months |
incidence of ECG abnormalities in Phase 1a combination with T-DXd | Not Specified | 24 months |
incidence of dose limiting toxicities in Phase 1a combination with trastuzumab emantasine (T-DM1) | Not Specified | 42 days |
Incidence of adverse events in Phase 1a combination with T-DM1 | Not Specified | 24 months |
incidence of laboratory abnormalities in Phase 1a combination with T-DM1 | Not Specified | 24 months |
incidence of ECG abnormalities in Phase 1a combination with T-DM1 | Not Specified | 24 months |
Incidence of adverse events in Phase 1b monotherapy | Not Specified | 24 months |
incidence of laboratory abnormalities in Phase 1b monotherapy | Not Specified | 24 months |
incidence of ECG abnormalities in Phase 1b monotherapy | Not Specified | 24 months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Objective Response rate in Phase 1a monotherapy | For patients with measurable disease at baseline, confirmed response per RECIST 1.1 | 24 months |
Objective response rate in Phase 1b monotherapy | Confirmed response per RECIST 1.1 | 24 months |
Duration of response in Phase 1b monotherapy | The time from the first response to progression or death per RECIST 1.1 | 24 months |
Brain metastases response in Phase 1b monotherapy | for patients with measurable brain metastases at baseline, the percent of patients who have a confirmed response per RECIST 1.1 | 24 months |
PK parameter of area under the curve of ELVN-002 in Phase 1a monotherapy | the concentration of ELVN-002 measured in the blood over 24 hours at steady state | 21 days |
PK parameter of maximum concentration of ELVN-002 in Phase 1a monotherapy | the maximum concentration of ELVN-002 measured in the blood at any time point at steady state | 21 days |
PK parameter of terminal half life of ELVN-002 in Phase 1a monotherapy | the half life of ELVN-002 calculated from the concentration of ELVN-002 in blood | 21 days |
PK parameter of area under the curve of ELVN-002 in Phase 1b monotherapy | the concentration of ELVN-002 measured in the blood over 24 hours at steady state | 21 days |
PK parameter of maximum concentration of ELVN-002 in Phase 1b monotherapy | the maximum concentration of ELVN-002 measured in the blood at any time point at steady state | 21 days |
PK parameter of terminal half life of ELVN-002 in Phase 1b monotherapy | the half life of ELVN-002 calculated from the concentration of ELVN-002 in blood | 21 days |
Frequently Asked Questions
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