EGFR-mutated NSCLC (Disorder)Phase 1NCT03418532
MP0250 DARPin® Protein Plus Osimertinib in Patients With EGFR-mutated NSCLC
A Phase 1 study testing MP0250 DARPin® drug candidate, Osimertinib in people with EGFR-mutated NSCLC (Disorder), run by Molecular Partners AG at 10 sites in United States.
Trial summary
The purpose of this study is to assess the anti-tumor efficacy, safety, tolerability, pharmacokinetics (PK), immunogenicity and biological activity of the MP0250 DARPin® drug candidate in combination with osimertinib orally once daily (o.d.), when administered to patients with EGFR mutated, advanced, non squamous… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EGFR-mutated NSCLC (Disorder)
- What is being tested?
- MP0250 DARPin® drug candidate, Osimertinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 10 sitesUnited States
- Study dates
- 22 Mar 2018to 24 Apr 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed metastatic or unresectable locally advanced non-squamous NSCLC with documented EGFR mutation-positive disease
- Radiologically documented disease progression on previous osimertinib treatment.
- Radiologically documented disease progression on or after most recent antitumor therapy.
- Measurable disease according to RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 2.
- Men and women ≥18 years old on the day of signing informed consent.
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- Adequate hematological, hepatic and renal function prior to first dose
- Serum albumin concentration ≥30 g/L
- Potassium and magnesium within normal range
Who cannot join
- Necrotic tumors or tumors close to large blood vessels that may impose an increased bleeding risk when treated with anti-VEGF agents.
- Second malignancy that is currently clinically significant or required active intervention during the period of 12 months prior to Screening, except early stage non-melanoma skin cancer treated with curative intent.
- Known pre-existing interstitial or inflammatory lung disease.
- Clinical signs of or documented leptomeningeal carcinomatosis. Features such as headache, nuchal rigidity, and photophobia may indicate meningeal involvement.
- Known brain metastases who are clinically unstable
- Prohibited anti-NSCLC therapies and not having recovered from related AEs to Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤1
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- Any investigational drug within 28 days prior to study treatment.
- Current participation in any other interventional clinical study (except survival follow up).
- Neuropathy as residual toxicity after prior antitumor therapy Grade >2
- Patients taking medications that have the potential to prolong the QT interval
- Significant cardiac abnormalities
- Uncontrolled hypertension
- Significant risk for bleeding
- Active or recent thrombolic events
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
UT Southwestern Medical Center
Dallas, Texas, 75390
City of Hope - Comprehensive Cancer Center
Duarte, California, 91010
Duke Cancer Institute
Durham, North Carolina, 27710
Oncology Consultants
Houston, Texas, 77030
Tennessee Oncology
Nashville, Tennessee, 37203
Florida Hospital
Orlando, Florida, 32803
University of California
San Diego, California, 92093
UCLA Medical Center
Santa Monica, California, 90404
Scottsdale Healthcare Hospitals
Scottsdale, Arizona, 85258
Georgetown University
Washington D.C., District of Columbia, 20057
About this study
Official title: A Phase 1b/2, Single-arm, Open-label, Multi-center Study of MP0250 in Combination With Osimertinib in Patients With EGFR-mutated Non-squamous Non-small Cell Lung Cancer (NSCLC) Pretreated With Osimertinib
The purpose of this study is to assess the anti-tumor efficacy, safety, tolerability, pharmacokinetics (PK), immunogenicity and biological activity of the MP0250 DARPin® drug candidate in combination with osimertinib orally once daily (o.d.), when administered to patients with EGFR mutated, advanced, non squamous NSCLC after tumor progression on osimertinib and on or after the most recent therapy.
MP0250 is a multi-DARPin® protein with three specificities, able to simultaneously neutralize the activities of vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF) and also to bind to human serum albumin (HSA) to give an increased plasma half-life and potentially enhanced tumor penetration.
- Conditions
- EGFR-mutated NSCLC (Disorder)
- Being tested
- MP0250 DARPin® drug candidate, Osimertinib
- Keywords
- DARPin®protein, MP0250, VEGF, HGF, NSCLC, EGFR mutated, Osimertinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MP0250 DARPin® drug candidate, OsimertinibCombination product
Number of Cycles: until progression, unacceptable toxicity or other reasons for withdrawal
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | MP0250 DARPin® drug candidate (6 mg/kg or 8 mg/kg or 12 mg/kg, infusion) on day 1 of each 21 day cycle. Osimertinib according to label Receives: Combination Product: MP0250 DARPin® drug candidate, Osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the objective response rate (ORR)
Tumor response will be assessed based on RECIST 1.1 by using CT or MRI
Measured: 6 months
Secondary outcomes (10)
Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to CTCAE, v4.03.
number of patients with AE/SAE on the base of CTCAE (version 4.03)
Measured: 15 months
progression free survival (PFS)
PFS according to RECIST 1.1
Measured: 12 months
duration of response (DOR)
DOR according to RECIST 1.1
Measured: 9 months
overall survival (OS)
time from the date of first dose of MP0250 until death from any cause or until 1 year for all patients
Measured: 24 months
time to response (TTR)
TTR according to RECIST 1.1
Measured: 4 months
Incidence of anti-drug (MP0250) antibody formation
determined as titer of anti-drug antibodies
Measured: 15 months
pharmacokinetics
half-life
Measured: 15 months
pharmacokinetics
clearance
Measured: 15 months
pharmacokinetics
AUC
Measured: 15 months
pharmacokinetics
Cmax
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start22 Mar 2018
- Primary completion30 Aug 2019
- Study completion24 Apr 2020
Why it stopped: Sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR-mutated NSCLC (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The trial was intended to be a Phase 1/2 trial. Trial was terminated before Phase 2 commenced.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molecular Partners AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418532
- Sponsor's protocol ID
- MP0250-CP202
- Status last verified
- Mar 2023
- First submitted
- 10 Jan 2018
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2, Single-arm, Open-label, Multi-center Study of MP0250 in Combination With Osimertinib in Patients With EGFR-mutated Non-squamous Non-small Cell Lung Cancer (NSCLC) Pretreated With Osimertinib
- ClinicalTrials.gov ID
- NCT03418532
- Acronym / sponsor ID
- MP0250-CP202
- Conditions
- EGFR-mutated NSCLC (Disorder)
- Keywords
- DARPin®protein, MP0250, VEGF, HGF, NSCLC, EGFR mutated, Osimertinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Molecular Partners AGIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 24 Apr 2020 (actual)
- First posted
- 1 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the anti-tumor efficacy, safety, tolerability, pharmacokinetics (PK), immunogenicity and biological activity of the MP0250 DARPin® drug candidate in combination with osimertinib orally once daily (o.d.), when administered to patients with EGFR mutated, advanced, non squamous NSCLC after tumor progression on osimertinib and on or after the most recent therapy.
MP0250 is a multi-DARPin® protein with three specificities, able to simultaneously neutralize the activities of vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF) and also to bind to human serum albumin (HSA) to give an increased plasma half-life and potentially enhanced tumor penetration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The trial was intended to be a Phase 1/2 trial. Trial was terminated before Phase 2 commenced.
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Combination Product: MP0250 DARPin® drug candidate, OsimertinibMP0250 DARPin® drug candidate (6 mg/kg or 8 mg/kg or 12 mg/kg, infusion) on day 1 of each 21 day cycle. Osimertinib according to label |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed metastatic or unresectable locally advanced non-squamous NSCLC with documented EGFR mutation-positive disease
- Radiologically documented disease progression on previous osimertinib treatment.
- Radiologically documented disease progression on or after most recent antitumor therapy.
- Measurable disease according to RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 2.
Key exclusion criteria (14 listed)
- Necrotic tumors or tumors close to large blood vessels that may impose an increased bleeding risk when treated with anti-VEGF agents.
- Second malignancy that is currently clinically significant or required active intervention during the period of 12 months prior to Screening, except early stage non-melanoma skin cancer treated with curative intent.
- Known pre-existing interstitial or inflammatory lung disease.
- Clinical signs of or documented leptomeningeal carcinomatosis. Features such as headache, nuchal rigidity, and photophobia may indicate meningeal involvement.
- Known brain metastases who are clinically unstable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MP0250 DARPin® drug candidate, OsimertinibNumber of Cycles: until progression, unacceptable toxicity or other reasons for withdrawal | Combination product | single arm |
Primary outcome
Estimate the objective response rate (ORR)
Time frame: 6 months
Tumor response will be assessed based on RECIST 1.1 by using CT or MRI
10 secondary outcomes
Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to CTCAE, v4.03.
Time frame: 15 months
progression free survival (PFS)
Time frame: 12 months
duration of response (DOR)
Time frame: 9 months
overall survival (OS)
Time frame: 24 months
time to response (TTR)
Time frame: 4 months
Incidence of anti-drug (MP0250) antibody formation
Time frame: 15 months
pharmacokinetics
Time frame: 15 months
pharmacokinetics
Time frame: 15 months
pharmacokinetics
Time frame: 15 months
pharmacokinetics
Time frame: 15 months
Results and safety
The study was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MP0250 DARPin® drug candidate, Osimertinib in people with EGFR-mutated NSCLC (Disorder), run by Molecular Partners AG at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate the objective response rate (ORR) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.